Commercialization, marketing and social media

As regulators and commercial payers tighten the screws on pharma’s profits, companies need to get the ball rolling early to position drugs for a competitive market. 

Convincing payers and doctors that breakthroughs and first-in-class therapies are worth the investment can be tricky, and many drugmakers are beginning to think about coverage and reimbursement strategy as early as phase 1, according to a recent report from Norstella.

“A thoughtful market access strategy early in the development process is key to launch success in this world of personalized medicine, especially for competitive launches, where there are many different classes of treatment available,” said Catherine Humphries, senior consultant in advisory services at MMIT, a Norstella company, in an email to PharmaVoice.

Many companies find that making a successful case requires newer tools such as real-world data and AI analyses because clinical performance alone might not always be enough.

“Increasingly, payers are asking manufacturers to provide evidence of a brand’s superiority beyond mere trial results,” Humphries said. 

Real-world patient data can highlight cost savings and improved outcomes, showing that patients who receive the drug need fewer emergency room visits or have better symptom control, for example.

A tough market

Pharma companies have lost some of their pricing power due to factors like Medicare’s newfound drug negotiation position, which the industry has been fighting in court. Pharmacy benefit managers have also been accused of jacking up drug prices, drawing fire from the Federal Trade Commission. 

In an increasingly competitive landscape, commercial payers can force drug discounts that leave drugmakers out in the cold, Humphries said. These add to existing financial stressors like rising R&D costs and shrinking patient pools as medicines become more targeted. 

“[Pharmas] face an evolving environment that requires more emphasis on efficiency of decision-making and cost savings at every step possible,” Humphries said.

To thrive in this environment, Humphries said pharmas need an “agile brand strategy response” to navigate the thicket of payers, group purchasing organizations, integrated delivery networks, oncology pathways and healthcare providers.

Evidence of a drug's value must be compelling enough to woo payers and doctors along with value analysis committees and health technology assessment organizations, which requires a more creative approach, Humphries said.

Companies can demonstrate additional value to insurers by becoming a critical resource and offering educational support for prescribers and patients. For example, the rise of biosimilars in U.S. markets demonstrates the importance of that support, Humphries said.

“In the inflammatory space, biosimilar manufacturers are providing patient support programs similar to those of the reference brands, which helps payer decision-makers feel more confident that their members’ service level will remain high if switched to a biosimilar,” Humphries said. 

Manufacturers in rare diseases and cancer subtypes are mining real-world data and lab test results to identify specialists who need education for challenging diagnoses. 

AI can also help companies quickly assess the competitive landscape to determine other ways to make their product appealing to doctors and patients. 

“Being able to launch a treatment for rare diseases that features convenient dosing, or that treats additional patient populations, can give your brand a real advantage at launch,” Humphries said.

The earlier companies start positioning a drug for a successful launch, the better.

“By the time a drug receives regulatory approval, a clear strategy should be in place to best meet the demand of payers, who will look for increasingly robust evidence that extends beyond clinical trials and into value for spend,” Humphries said. “A comprehensive strategy will include determining how to present payers, providers, value analysis committees and health technology assessment organizations with compelling evidence of the product’s value.”

The economy is on solid footing, interest rates are dropping and the stars are aligning for pharma companies to offset patent expirations with new drugs. But amid these favorable market dynamics lies a weighty uncertainty: tariffs and other economic levers promised by the new presidential administration. 

The incoming Trump administration has pledged to impose broad levies, with tariffs as high as 60% on Chinese goods and 20% to 25% on those from Canada and Mexico. The unresolved Biosecure Act could also deal a blow to China as the U.S. aims to shore up national security by prohibiting companies that receive federal funds from making business deals with five key Chinese biotechs. The legislation has stalled in the Senate, but some experts expect it to ultimately gain approval, potentially reshaping supply chains through 2032, said Arda Ural, EY Americas industry markets leader for health sciences and wellness. 

Companies would be wise to get ready, Ural said. 

“We expect the president-elect to continue to promote on-shoring, near-shoring and to use tariffs and other economic levers to implement his economic, national security and foreign policy priorities,” he said. “Agile companies will understand and be prepared for these externalities.” 

An international pivot

Tariff promises might not translate directly into policy, Ural said. Even so, many companies have begun shifting operations away from Chinese businesses, which make up 13% of global active pharmaceutical ingredient manufacturers. But these are capital-intensive, long-term strategic moves, Ural said. Some are reshoring to the U.S. or looking to other countries such as Vietnam as China loses its appeal. 

“Vietnam may emerge alongside India in secondary and tertiary markets to de-risk China’s geopolitical [position],” Ural said. “Those are happening real time.”

Mexico has also become an attractive alternative as companies look to diversify operations. 

“Mexico has the added benefit of proximity and the same time zone,” Ural said. However, while Mexico has become a pharma hotspot, the effect of tariffs on the neighboring country is less clear. 

An unequal burden

For branded pharmaceuticals, pivoting to avoid tariffs on APIs is inconvenient and costly but doable. 

“This is not a situation where you need rare minerals — it’s not like these products don't exist anywhere else in the world,” Ural said. “It's just a matter of shifting the bases from China, which is a higher geopolitical risk, to more friendly manufacturing bases.”

But companies making generic products, hamstrung by cost constraints, are less nimble, and tariffs could ultimately drive up prices for consumers. On all counts, moves to mitigate the effects of tariffs on the industry will likely bring short-term pain. 

“Moving pharma or medtech manufacturing from China to other countries is a complex and capital-intensive undertaking,” Ural said. “It encompasses reimagining supply chain processes and footprint, has tax implications, and certainly has regulatory implications to comply with FDA’s audit requirements and maintaining quality standards.”

Those pivots, however, can potentially lead to longer-term benefits, positioning companies for the future. 

“While diversifying in this way is a massive capital-intensive undertaking both strategically and operationally, the good news is that it mitigates long-term geopolitical risk in an increasingly decoupled global economy,” Ural said.

The times, they are a-changing

U.S. economic indicators appear to be moving in the right direction to boost development, but there are additional uncertainties beyond tariffs. The industry has been uncharacteristically quick to adopt artificial intelligence, which has the potential to accelerate R&D and save money, Ural said. This year, the industry is likely to get some answers on how well that investment will pay off.  

“We are probably past the hype cycle in AI right now,” Ural said, noting that now those technology investments have to deliver. “I am optimistic about AI’s ability to stick, but the question is to what degree.”

It’s not the only outstanding question. 

“If there are new unknowns, they will probably come from the geopolitical side of the house,” Ural said. 

For example, will China retaliate against antagonistic legislation and tariffs? Could it spark drug shortages? 

“The ability to pivot in the next three to six months quickly will be key,” Ural said, adding that companies need to keep the focus on critical and fundamental priorities. “The discipline to focus on driving your own portfolio will be very important, because if there's no revenue, there's no margin — there’s nothing.”

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Eli Lilly’s recently announced plan to partner with digital health company Ro on its LillyDirect platform marks a new turning point in the direct-to-consumer push among Big Pharma companies. 

Ro, which launched in 2017, offers online prescriptions under the “wellness” bucket including drugs aimed at obesity, sexual health and hair loss — a model similar to digital health companies like Hims & Hers. 

Under the partnership, Ro is now integrated with LillyDirect — the pharma giant’s DTC platform for diabetes, migraine and obesity — allowing customers to seek out Lilly’s blockbuster weight loss medication Zepound in a new formulation. In August, Lilly released Zepbound single-dose vials at around a 50% discount. Ro now offers the single-dose vials, the injectable pen, as well as Novo Nordisk’s Ozempic and Wegovy semaglutide pens.

At the same time, Ro also competes with the branded versions through compounded semaglutide drugs for weight loss.

Lilly and Novo, the undisputed leaders in the obesity market, have been locked in a battle with pharmacies that make compounded versions of their GLP-1 medications. Under FDA rules, compounded medications are allowed to be sold when the FDA-approved, brand versions are in shortage. And the FDA is currently reviewing a shortage decision on GLP-1s that has kept compounded versions on the market.

The integration reflects how Big Pharma companies are adapting to the DTC trend and seeking market share while simultaneously fighting to take compounded GLP-1s off the market. Lilly’s deal with Ro also comes as lawmakers question whether pharma’s DTC platforms are even legal.

Compounded complications

To strike the partnership, Ro strove to maintain “independent clinical decision making,” according to CEO Zach Reitano, which was also important to Lilly. That independence means Ro will sell compounded semaglutide as long as the law allows. 

“We will continue to follow all applicable laws and FDA guidance as it relates to compounding, ” he said. “We believe in the premise of compounding and the role it plays in the healthcare system, and that providers should have access to that tool.”

The FDA is scheduled to update its compounded GLP-1 shortage review Dec. 19, but the agency could delay that decision. In October, the FDA removed Lilly’s Zepbound and diabetes drug Mounjaro from its shortage list, requiring compounding pharmacies to stop manufacturing and selling their versions of the drugs. After a group of compounders sued, the FDA reversed its decision, leading to the current limbo. 

Notably, Ro doesn’t sell compounded versions of tirzepatide, the ingredient in Lilly’s GLP-1 drugs, but it does sell compounded semaglutide. Novo’s semaglutide weight loss drug Wegovy was marked as being in a supply shortage on Ro’s website as of Dec. 17.

Thanks to the discount on Ro, Zepbound single-dose vials also cost closer to what patients pay for compounded GLP-1s from other telehealth providers, and significantly less expensive than the injectable pens, which have a list price around $1,000 per month. Through Ro, the vials cost $399 for the first month’s supply and $549 every month afterward.

“It's the most affordable brand of GLP-1,” Reitano said.

According to Reitano, Ro isn’t targeting patients who want to switch from compounded GLP-1s to the name-brand but less pricey Zepbound vials. Instead, the strategy is to offer branded products and compounded versions based on availability. 

DTC expansion

As Lilly seeks a wider market share for Zepbound, Senators have continued to raise questions around the legality of pharma companies selling prescriptions directly to patients through online healthcare providers. Earlier this fall, a group of Senators sent letters to Lilly and Pfizer, which launched its own PfizerforAll DTC platform this year, to determine whether the platforms violate anti-kickback laws.

Lilly and Pfizer recently responded by pointing out that telehealth providers are not being paid to prescribe their medications. Lilly also asked Senators to question compound pharmacies directly, according to Endpoints News.

Pfizer stated it pays a monthly fee regardless of what telehealth providers prescribe.

Lilly and Pfizer are the first Big Pharma companies to launch DTC platforms, but more could be on the way, particularly for drugs targeting obesity. 

“Obesity is unique in the sense that the majority of the U.S. population is overweight or obese,” Reitano said. “These drugs are quite effective. Patients want it, providers want it and the product is also quite scalable. [This has] never occurred at the same time for a drug class.”

Digital health companies that offer obesity solutions, including Ro, could also benefit from the incoming Trump administration's planned focus on chronic disease management. Robert F. Kennedy Jr., who was nominated to lead the Department of Health and Human Services, has stated a commitment to reducing chronic disease rates, including obesity, within a few years. He also publicly harped on the high cost of Ozempic in the U.S. compared to other countries. 

“I'm optimistic about this new administration. I think that both the current and the new administration, while they don't agree on much … agree on the overwhelming burden of chronic disease in the U.S. and the fact that drug prices are too high,” Reitano said.

To launch a drug in the ultra-rare disease space, the path to commercialization is narrow. In developing the first treatment for a rare genetic disease that impacts only an estimated 900 people in the U.S., Zevra Therapeutics had to keep the end game in mind early on. 

“Awareness for [a] new therapy takes place through the clinical trials,” said Josh Schafer, Zevra’s chief commercial officer. 

The pharma received FDA approval in September for Miplyffa, the first therapy for Niemann-Pick disease type C, which is caused by genetic mutations in the NPC1 or NPC2 genes that affect how the body breaks down fats and lipids. While the patient population for NPC is small, the number of diagnosed cases is even smaller, around a few hundred globally. With a first-in-disease approval and recent availability of Miplyffa, Zevra is now ramping up its reach.

Ultra-rare model

Miplyffa has been available commercially since November at a cost of more than $100,000 per month — more than $1 million annually. Early adoption has exceeded expectations, president and CEO Neil F. McFarlane said. 

Miplyffa is used in combination with miglustat, a glucosylceramide synthase inhibitor that has been used off-label to treat NPC patients. Treating the neurological symptoms of NPC in adults and children 2 and older, the combination therapy stopped disease progression through 12 months for patients in the clinic.

During a third-quarter earnings call, Zevra announced that it reached 90 patients for Miplyffa and was working through the reimbursement process.

“We've seen great success there in terms of payers’ willingness to pay for Miplyffa,” Schafer said. “[The launch] exceeded our expectations in terms of the interest and the demand and, more importantly, our ability to be able to process all those enrollments, to be able to get them authorized for payment from the insurance companies and from Medicaid and Medicare.”

The company also continues to treat patients in its ongoing trials — 83 in its early access program have been taking Miplyffa for as many as five years already. Of that group, 69 were converted from the early access program to the commercially available Miplyffa, according to McFarlane.

“More than 270 patients have received Miplyffa through one of the trials that we've conducted,” Schafer said. “It's typical to sort of see that as the starting [point] and the accelerator for any rare disease launch.”

But Zevra wants to reach more patients and is looking to clinicians to help confirm more diagnoses of the disease. NPC can be mistaken for other conditions such as Gaucher disease, and as part of its commercialization strategy, Zevra is seeking those misdiagnosed patients to broaden its therapeutic reach. 

“The way to make a commercially viable opportunity for rare disease is to focus on trying to increase the diagnosis of patients who suffer from that disease,” Schafer said. “What we're trying to do is bring effective treatments to those patients who have already been diagnosed, but then raise awareness and education around how best to treat patients who may be misdiagnosed today.”

And there are already some groups advocating for NPC screening at birth, according to Schafer.

Financial footing

With the U.S. launch underway, Zevra is looking to expand Miplyffa to Europe, with regulatory submission expected in 2025, McFarlane said during the earnings call.

Elsewhere in Zevra’s portfolio, a urea cycle disorder treatment called Olpruva is underperforming, with only three new patient enrollments during the third quarter of 2024, according to the earnings report. Zevra launched Olpruva at the beginning of 2024 after it acquired Acer Therapeutics. Zevra also has an ADHD drug, Azstarys, on the market. The two drugs brought in about $1 million in third quarter revenue.

“We're talking about a company that had never commercialized the product,” McFarlane said. “Since the beginning of the year, we've launched a product in UCD, and now we've actually gotten approval of the first product ever for NPC. If I think about the lessons that we've learned in the first launch, we're applying those lessons. We're listening and we're building the depth and strength in our organization to be able to prove that we can commercialize ultra-rare disease drugs.”

The lessons from Olpruva’s launch have also helped Zevra achieve greater success with Miplyffa’s early days. 

“Our commercial team was really sort of built fit-for-purpose to be able to bring multiple products to the rare disease community with a really focused effort with overlapping call points,” Schafer said. “It helps us with both products. We have relationships that help open doors and initiate conversations with clinicians because we have both of these products. That is fundamental to who we are and how we're growing.”

Still, the rare disease company has a cash runway into 2027 after completing a public offering in August that raised nearly $65 million. In the pipeline, Zevra has another asset, KP1077, targeting rare sleep disorders in phase 1 and 2 trials, as well as a phase 3 trial for a vascular Ehlers-Danlos syndrome treatment.

“I have no favorite child,” McFarlane said of the company’s portfolio. “The reality is that we are launching two products in two critical therapeutic areas right now, and we have two late-stage development programs. We're developing products for patients who don't have a lot of therapeutic options. Our goal is to be able to bring these products across the regulatory hurdles and then commercialize them and make it as easy as possible for patients to receive these therapies.”

In the U.S. drug market, which is one of only a few that allows direct-to-consumer advertising, it sometimes takes an unconventional approach to stand apart from the crowd.

Pharma companies shifted marketing practices last year, spending more to target select consumer groups while cutting back on sales efforts focused on healthcare professionals, according to a marketing survey conducted by MM+M. They’re also spending more on non-linear TV and digital media.

Quirky ads that aim to raise awareness about diseases or drugs can make an important impression on patients and consumers. Drugmakers with first-in-class or first-in-disease treatments are also taking novel approaches to promote their products.

Here’s a look at three unique marketing plays in 2024 from the pharma world.

Veozah’s Super Bowl dreams

Astellas Pharmas’ Veozah was a “game-changer” menopause treatment when it was approved in May last year. The drug, a neurokinin 3 receptor antagonist, offered the first approved nonhormonal treatment for hot flashes, which affect about 75% of menopausal women. But the company found that uptake of the drug was slower than expected, due to misconceptions about the coverage landscape and prescriber hesitancy. 

So Astellas aimed to boost awareness and education for healthcare providers and patients on one of the largest stages in the world: the Super Bowl. 

The company purchased a 2024 Super Bowl ad spot in February when 30-second commercials were selling at a reported cost of about $7 million. The ad stressed that the drug is hormone free and can change hot flashes to “not flashes.” It wasn’t Astellas’ first trip to the big game — in 2023, the drugmaker bought an ad prior to the drug’s approval to raise awareness of vasomotor symptoms like hot flashes and night sweats to get the ball rolling.

Despite the high price tag for ads, the Astellas promotion was ranked 64 out of 96 Super Bowl ads for consumer engagement. Still, its presence at the game was notable for taking advantage of a shrinking gender gap among Super Bowl watchers. The 2024 game brought in the most female viewers ever, reaching nearly 59 million women, who made up 48% of the audience. 

Veozah sales also surpassed $95 million during the first six months of 2024, according to a recent earnings report — a massive jump from $47 million in 2023.

Mr. Mucus’ dating profile

Reckitt Benckiser, a British-Dutch multinational consumer goods company, gave its Mucinex mascot, Mr. Mucus, a tongue-in-cheek profile on the dating app Tinder this fall to promote its over-the-counter nighttime cold and flu medicine Mucinex Nightshift. 

The cartoon mascot’s profile featured images that leaned into cringe-worthy online dating cliches, such as holding up a freshly caught fish and set up Tinder users to find Mr. Mucus — a personified snot blob — while swiping on the app.

The company timed the marketing play, dubbed the “No Regrets” campaign, with cold and flu season, which is also known as “cuffing season,” or when single people seek partners to spend the chilly months with.

In addition to targeting singles, the Tinder spot was designed to “encourage consumers to make smarter nighttime decisions so they have a better morning,” the company said in a press release. 

Genentech’s SMA musical

When a pharma company wants to raise awareness about a rare disease for which they have an approved treatment, why not a 45-minute musical directed by a Tony-nominated actor? That’s the approach Genentech took this year to put spinal muscular atrophy in front of audiences. 

SMA, a rare neuromuscular disorder triggered by a deficiency of a motor neuron protein that leads to muscle weakness and atrophy, is a “major” cause of infant death when untreated, according to Johns Hopkins Medicine.

The satirical musical, “Most Likely Not To…,” shined a light on the impact of ableism by following a protagonist traveling to her 20-year high school reunion who encounters challenges along the way, like inaccessible airplane bathrooms. It was written and performed by members of the SMA community, including influencer Shane Burcaw, and directed by actor, singer and puppeteer John Tartaglia.

The musical was sponsored by Genentech and performed at Times Center in New York City earlier this year.

For Genentech, the performance coincided with Rare Disease Day in February and was part of the company's SMA My Way program, which aims to highlight the lived experiences of people with the disease.

Genentech’s SMA treatment Evrysdi was approved in 2020 for all ages to treat SMA, with the aim to improve motor function. Sales of Evrysdi topped $1.6 billion last year, and $1.4 billion in the first half of 2024.

At a company the size of Johnson & Johnson, it would be easy for departments to become siloed, accomplishing only their own objectives without a vision of the bigger picture. But even in the earliest stages of science, units as fundamentally divided as clinical research and commercial strategy work together to achieve the pharma giant’s common goal.

As J&J pursues clinical results, Dr. Craig Tendler, vice president of late-stage development, diagnostics and global medical affairs in oncology, has to consider not only what’s happening in a non-small cell lung cancer trial but what the commercial landscape will look like so patients can ultimately benefit.

“The way I look at the commercial contribution before we even get on the market is trying to define those key attributes that are important to physicians and patients and being able to integrate that into a development program where the results will hopefully support that profile,” Tendler said. 

So he teams up early with Biljana Naumovic, J&J’s president of U.S. solid tumor oncology, to ensure everyone is on the same page. Along with the research teams, Naumovic aims to define those key attributes at the outset.

“The primary end goal is to transform the lives of patients by changing the standard of care and supporting a long, fruitful quality of life,” Naumovic said. “We’re part of this discussion at the very beginning, so that before we go into the clinic, we’re defining where we want to go — for the past 20 years, we have done just that with very informed, passionate debates.”

If a program looks like it’s not going to change the standard of care, “we stop things that we do not think are going to hit the mark,” Naumovic said.

‘A huge responsibility’

When the baton makes its way from the clinical research teams to the commercial department, everyone needs to be on the same wavelength, Naumovic said.

“Bringing really strong data to then manage patients better is a huge responsibility,” Naumovic said, referring to the August FDA approval that stemmed from overall survival data in a late-stage study for EGFR-mutated non-small cell lung cancer with the drug combo of Rybrevant and Lazcluze compared with AstraZeneca’s Tagrisso, the current standard of care.

On the research side, patients stayed on the Rybrevant and Lazcluze combination treatment longer than with Tagrisso, Tendler said, noting that the combo provided better disease control, which is a selling point down the road. And that arises from early representation of the commercial perspective in clinical program design, he said.

“The beauty of having the commercial representation is that we have better insight as to what attributes should be integrated into the comprehensive development program,” Tendler said. “This idea that we have to look to not just bring a regimen that has enhanced progression-free survival but the factor that will convince physicians to use it in a higher proportion of patients is the survival data.”

At a conference with clinical experts like this past weekend’s annual conference of the European Society for Medical Oncology, Naumovic’s job is to distill the next steps into a commercial plan.

“Once the data is out, the oncology community has a million ideas for where to take it next,” Naumovic said. “And so we can create that together.”

In bladder cancer, for instance, J&J reported mid-stage data for a device called TAR-200 designed to sit in the bladder and release chemotherapy from within, showing a response rate of more than 83%.

“It’s a very clear example of an innovation being able to deliver an older drug in a new delivery device and having it get much more effective levels throughout the treatment cycle,” Tendler said.

Results like that give Naumovic some buzz to work with when the commercial strategy comes into play.

“This has never been seen before in localized bladder cancer, and to get there with a beautifully engineered device that stays in the bladder will be a radical change to what bladder cancer looks like once we bring it to the U.S. market in the beginning of next year,” Naumovic said.

The commercial influence

While science can only be done at its own pace, commercial demand can sometimes influence the direction in which a research team takes aim. A rise in colorectal cancer among young patients has troubled oncologists and caused companies like J&J to investigate new treatment options.

In a phase 1b/2 study for patients with metastatic colorectal cancer, a combination of Rybrevant and chemotherapy resulted in an almost 50% overall response rate.

“There has been no innovation in colorectal since [Eli Lilly’s Erbitux], and we’re talking several decades,” Naumovic said. “So like we did in bladder cancer and lung cancer, we’re coming to colorectal cancer the same way — there certainly is a resurgence of higher incidence in a younger population across the developed world because of diet, and we want to make sure we’re embracing that opportunity with the results that we have.”

Overall, J&J’s clinical and commercial teams have the same endpoints in mind — finding the right approaches to move the oncology field forward while keeping today’s patients at the center of the equation.

“We are a company that aims to put chemotherapy into the history museums where it belongs and focus on targeted therapies that will allow patients to live a longer and better life,” Naumovic said. “That’s where we think the field of oncology is going.”

Imdelltra. Lumisight. Zevtera.

These new, invented-from-scratch words are now the brand names for three newly FDA-approved drugs, representing a small cell lung cancer treatment, an optical imaging agent for cancer detection and an antibiotic, respectively.

A drug’s name not only has to be memorable and evocative in some way, but also must adhere to strict guidelines from the FDA, since it will be approved along with the drug label.

“There's a lot of legal and viability aspects in naming that need to be considered, and those take months and months,” said Jonathan Finer, director of strategy at Conran Design Group, a brand and design consultancy that he said counts major pharma companies like Johnson & Johnson, Sanofi, Pfizer, Novartis and Merck & Co. as clients. “In many ways, those are the more arduous, rigorous aspects of the naming process.”

Today, the R&D and commercialization process moves faster than ever, and the branded drug space has never been more crowded, with thousands of new drugs in development. That’s why Finer said companies should start the naming process “as early as possible” to ensure the name works from a regulatory, patent, trademark, language, URL availability and branding perspective.

“Think about it really early in the commercialization process,” he said. “A name is a really exciting thing. It's the shortest story that we can tell about a brand. It’s the way in which we identify the brand.”

Here are three key considerations for the drug naming process.

Passing the regulatory hurdle

Before getting creative with a brand name, drug developers and branding experts must first ensure it fits within the FDA’s regulatory framework. For instance, it needs to be proprietary and newly coined, but it also can’t be too similar to any other existing brand names in spelling or pronunciation.

The main reason? The possibility of errors between drugs with similar names.

“The No. 1 legal parameter in naming is that there can never be any confusion, either in the patient's medicine cabinet or for the pharmacist at a large healthcare system,” Finer said. “From a legal perspective, it's creating a differentiation.”

The FDA’s newest guidance for drug naming, released in December 2020, lists other considerations, too, such as pronounceability; avoiding certain references to the drug’s ingredients and or how the drug is manufactured or administered; and steering clear of names that are too similar to brands in other countries.  

In fact, Finer said he always conducts a preliminary trademark screening of possible names due to the rigor of that aspect of the naming process.

“We will never show name candidates to a client before they have gone through preliminary legal screening,” he said. “It's extremely likely that candidates in the creative development phase will not be viable.”

Considering language and letters

In addition to considering existing brand names, pharma companies also need to think about other languages and cultural connotations in other countries, as well as current pharma naming conventions when naming new drugs.

The name not only needs to be “meaningful and attractive to the ear of an English speaker,” but also for speakers of other languages, too, from Romance to Slavic to Asian languages, Finer said. It also can’t translate to anything offensive or counterproductive.

In addition, there are pharma naming conventions that have evolved over the years and have become recognizable to and expected by consumers. In other words, they sound like a drug name.

“They feel like they have a similar construction: two to three syllables, often eliminating vowels, not having too many consonants in a row, truncating words and using alternative spellings and letters: the Y’s instead of I’s, the X’s instead of S's,” Finer said. “Those are the sorts of devices that have created a little bit of a convention in pharm naming.”

On the other hand, “bad” names might have too many consecutive consonants, making them confusing or hard to pronounce.

“Names like Evrysdi, Reyvow and Xywav reflect how innovative letter-strings and unique sounds are becoming the new standard,” Finer said. “Our challenge as namers will be balancing the need for names to both fit with this convention, and, as necessary, be disruptive.”

Evoking a feeling or idea

Although it sounds like drug naming is all about constraints, there are ways to get creative within those constraints.

“It takes us back to the most elemental part of those words, and that's the letter strings. It's how certain characters look together and sound together to form meaningful ideas — letter strings that allude to stories,” Finer said. “They allude to subject matters or some of the feelings … that we might have associated with the drug.”

A good example of this is the insomnia drug Lunesta, Finer said.

“A pharma name I really appreciate is Lunesta because it beautifully captures the essence of its function. The name evokes a sense of tranquility and restfulness, with 'Luna' referencing the moon, a universal symbol of sleep,” he said. “It's simple yet evocative, making it memorable and aligning perfectly with the product’s purpose of aiding sleep.”

The recently approved drug Lumisight seems to do this, too. It’s an IV-administered, fluorescent imaging drug that detects cancerous tissue after a lumpectomy, and its name alludes to both the fluorescence (lumi) and the way it helps with cancer detection (sight).

Finer also points to the name Skyrizi, the plaque psoriasis, psoriatic arthritis and Crohn’s disease treatment from AbbVie. It embeds the real word “sky” into the coined word to convey a feeling of lightness and clarity. That feeling is extended into other branding elements, too, such as the website, which shows an airplane soaring through a clear blue sky dotted with wispy white clouds.

The power of a name

Although it’s nearly impossible to quantify whether a name meaningfully impacts drug sales, it’s still important to come up with one that’s memorable, evocative and meaningful while still fitting within the FDA’s framework.

That’s because a name “is a very powerful thing in drawing connections,” Finer said.

“Once a drug has a commercial name, it really brings it to life in a distinctive way. It makes it more real and relatable, and that is the basis of building a connection, and branding is all about connection and relationship. This is that first, critical point.”