Lundbeck is bracing for the expected U.S. loss of exclusivity for its top-selling drug Rexulti at the end of 2028.
Despite falling short in its recent bid to snatch Avadel from Alkermes, Lundbeck is signaling to investors that it’s not desperate for deals and will not lower its standards for future M&A. Even as some analysts question the company’s midterm prospects following a major patent cliff, leadership says it will prioritize strategic fit and financial discipline over a quick fix.“We’re not willing to compromise,” Maria Alfaiate, Lundbeck’s EVP of corporate, portfolio and product strategy, said in an interview with Fierce Pharma on the sidelines of the J.P. Morgan Healthcare Conference 2026 in San Francisco.The biggest threat to Lundbeck’s business is perhaps the expected U.S. loss of exclusivity for Rexulti at the end of 2028. The Otsuka-partnered atypical antipsychotic is currently Lundbeck’s top-selling product, with 4.7 billion Danish kroner ($737 million) in sales for the first nine months of 2025, representing 26% year-over-year growth at constant exchange rates.Lundbeck’s own projection foretells a revenue plateau in 2029 and 2030, followed by accelerated growth if a couple of its pipeline products launch successfully, Thomas Gibbs, EVP and head of Lundbeck U.S., said. That long-term view underpins the company’s unwillingness to rush into subpar deals.“We would rather accept this plateau to then grow than actually compromise,” Alfaiate added. Gibbs described “programmatic business development” as a key strategy, saying Lundbeck is now in a position where it does not need to pursue a large acquisition.As to the unsolicited bid for Avadel, “we do see that there could be some benefit in terms of either a late-stage or on-the-market asset to help address that 2029-2030 gap,” Gibbs said.After Alkermes increased its offer for Avadel in response to Lundbeck’s unsolicited bid, Lundbeck did not raise its price further.Buying Avadel would have given Lundbeck an immediate revenue stream from the commercial narcolepsy drug Lumryz and an earlier entry into neuro rare disease, “but not at any cost,” Alfaiate said. “Ultimately, walking away, I believe, shows discipline.”But some analysts appear more concerned about Lundbeck’s post-Rexulti life and see a more urgent need for M&A.“Lundbeck has an intriguing pipeline, however potential market entry is 2028+E, and thus will not address the impact of Rexulti LoE in 2029E,” Jefferies analysts wrote in a November note.The Danish pharma is currently banking on growth from Rexulti and its anti-CGRP migraine drug Vyepti, while two late-stage programs—multiple system atrophy candidate amlenetug and bexicaserin for epilepsy disorders—could enter the market around the 2028 timeframe.Rexulti is facing big-name competition from Bristol Myers Squibb’s Cobenfy in schizophrenia and Johnson & Johnson’s Caplyta in major depressive disorder (MDD), and Axsome Therapeutics’ Auvelity is approved in MDD and gunning for an expansion into Alzheimer’s disease agitation.Schizophrenia only makes up about 7.9% of Rexulti’s revenue, while MDD represents 35%. Acknowledging that it’s still early days, Gibbs said Lundbeck has not yet detected an impact from Caplyta’s launch since November. In both MDD and Alzheimer’s disease agitation, Gibbs argued that more products being available could raise awareness, drive diagnosis and overall market growth. Lundbeck and Otsuka recently failed to convince the FDA of Rexulti’s value as a treatment for post-traumatic stress disorder because of mixed data across three clinical trials. According to Gibbs, the pair will not pursue the indication further with another trial as the FDA has suggested.“I think the data package that we submitted was probably, in totality, the best data that have been generated for patients who haven’t responded to [selective serotonin reuptake inhibitors],” Gibbs said. “When you look at the time for payback, it just doesn’t make sense to do anything else.”In 2024, Lundbeck handed responsibilities for its older MDD drug, Trintellix, to partner Takeda. The Danish pharma made the move to “disproportionately allocate resources to our biggest growth drivers,” including Rexulti, Gibbs said, rather than a product that’s slated to lose patent protection in 2026.“As elegant as we tried to be with co-positioning, what our data and analytics suggested is that when our sales force was promoting Rexulti and Trintellix at the same time, we had a 20% less productivity in terms of our impact on Rexulti versus when it was done alone,” Gibbs said. Following the separation, Rexulti’s year-on-year revenue growth reached 26% in the first nine months of 2025, versus 16% during the same period in 2024, without adding any new indications.As for Vyepti, the infused anti-CGRP therapy has gained traction in a market crowded with subcutaneous injectables and oral options. The drug’s sales rose 57% at constant currencies to nearly 3.3 billion Danish kroner ($518 million) in the first three quarters of 2025. Lundbeck has pegged Vyepti’s peak annual sales at more than $1.4 billion, including $1.1 billion in the U.S.Gibbs attributed Vyepti’s success to an infusion network, which helps patients navigate the entire treatment journey, as well as Lundbeck’s continued effort in building out Vyepti’s data package. The company recently rolled out real-world data suggesting that many patients may enjoy additional benefits from the infused drug following treatment with subcutaneous anti-CGRP therapy.In the pipeline, Lundbeck got bexicaserin through its $2.5 billion acquisition of Longboard Pharmaceuticals. With two phase 3 trials running in parallel in Dravet syndrome and other developmental and epileptic encephalopathy, the 5HT2C agonist is targeting a broad label and a potential market opportunity between $1.5 billion and $2 billion globally. The Longboard buyout fits Lundbeck’s focus on neuropsychiatry, neuro specialty and neuro rare disease; and according to Gibbs, any potential deals will have to fall within that bucket.“We’re not going to buy revenue,” Gibbs added. “It’s got to be a strategic fit that ideally has both revenue and a pipeline associated with it.”That means Lundbeck is not interested in obesity, despite the brain’s involvement in the disorder. Some biotechs have been looking to tackle obesity from a neurological perspective. Neurocrine Biosciences, another major neuroscience drug developer, just unveiled an obesity pipeline.“We’re a mid-size company,” Alfaiate said. “We need to be focused and follow the science in areas where we really understand the biology and where we can have the biggest impact.”“Sometimes in science, you do have some serendipity involved,” the strategy chief continued. “If that were to happen, this is probably something where we would partner with someone who knows what they’re doing, rather than trying to do it ourselves. We remain focused and dedicated to true brain health.”