Lyrica (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved in multiple indications. It has also been the highest-selling neurology brand for several years. As such, the company has tried using aggressive strategies to extend the brand’s lifecycle in order to protect it from generic competition.
Lyrica’s regulatory exclusivity for the treatment of epilepsy and anxiety expired in July 2014 in Europe, allowing generics to launch. Lyrica also had a second patent for its most lucrative market, neuropathic pain, which was not set to expire until July 2017. Pfizer sought legal challenges in the U.K. regarding the patent expiry, arguing that the generic pregabalin, which was set to launch for epilepsy and anxiety, would also be prescribed off-label by physicians, encroaching on the patented neuropathic pain use.
The Skinny Label
As such, Pfizer filed a lawsuit against Actavis (now Allergan) and Mylan, both of which were generic players that had launched generic pregabalin with a so-called “skinny label” that excluded pain. Additionally, Pfizer sent a warning to doctors not to prescribe generic pregabalin for neuropathic pain.
Two court rulings in September 2015 and October 2016 have since clarified that a generics maker can avoid infringement if it “takes all reasonable steps within its power” to prevent physicians prescribing it for the still-covered indication. On Nov. 14, 2018, the U.K. Supreme Court dismissed Pfizer’s last attempt at protecting its brand, and its secondary patent for neuropathic pain patent has been held invalid, opening the gates for further generic competition.
In the U.S., Pfizer won a court ruling that blocks any generic versions of Lyrica for any of its approved indications until December 2018, when its U.S. patents expire. Pfizer also filed for pediatric exclusivity for Lyrica in the U.S. If this is approved, it would extend Lyrica’s U.S. patent by six months, expiring on June 30, 2019.
Lyrica set for Significant Sales Erosion
As the brand has already been exposed to generic sales erosion in Europe, its sales have been declining since 2015. The U.K. Supreme Court decision is a blow for Pfizer since four out of five prescriptions for the drug were for pain. As such, this will result in a major drop in sales in the U.K. Lyrica is still enjoying its last few months of patent protection in the U.S.
However, once generics reach the market, Lyrica will see the most significant sales erosion from generics. Small molecule oral brands, such as Lyrica, can easily lose at least 50 percent of sales during the first full year of generic competition. With this in mind, GlobalData expects that global sales of Lyrica will drop from $5B in 2018 to $950M in 2024.
Lyrica is not the only Pfizer brand that will see sales decline due to generic competition. Consequently, the big pharma company is likely to turn to its favorite strategy, mergers and acquisitions, in an effort to replenish its pipeline with new potential blockbusters and offset the looming sales loss from its mature brands.