Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval

Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion.  

In a Securities and Exchange Commission (SEC) filing disclosed by Merck, Hikma notified the German company of their intention to seek FDA approval ahead of patent expiry on February 5, 2024 under the Hatch-Waxman Act (also termed the Drug Price Competition and Patent Term Restoration Act of 1984). Under the Hatch-Waxman Act, a company can seek approval to market a generic drug before the expiration of patents for a brand-name product. Merck thus has 45 days from Hikma’s notification to file an infringement suit. Should they choose to do so, approval of Hikma’s product will be delayed for 30 months until either the patent expires, or a judge decides against Merck.  

The Hatch-Waxman Act provides a legal framework for streamlining generic pharmaceutical approvals while continuing to incentivise pharmaceutical innovation. The act’s intention is to balance innovation by providing incentives for biopharma to research and develop new pharmaceuticals, while facilitating market approval for generic manufacturers in bringing affordable essential medications to market.  

Bridion, the pharmaceutical product in question, is an injection currently approved for reversing the effects of muscle relaxants used during surgeries. The patent is currently protected by a US District Court for the District of New Jersey order until at least January 2026. It was approved in 2015 and remains one of Merck’s top-selling products. In 2023, Bridion brought in just over US$1.8 billion for Merck. Patent expirations for the injectable has already occurred in the EU, Japan, and China.  

Future implications of any action taken by Merck and subsequent regulatory and court decisions will set significant precents for any patent disputes in the future. Last year, AbbVie’s blockbuster arthritis treatment Humira lost its patent, allowing biosimilar manufacturers to enter the market at significantly lower price points. With many more brand-name products closing in on their patent expiry dates, decisions made in the coming weeks could shape the future legal and regulatory landscape of pharmaceuticals. Merck has stated they are currently “evaluating its options”.  

Sources 

1. Merck’s Bridion faces generic threat from drugmaker Hikma [Accessed February 27, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-bridion-faces-generic-threat-drugmaker-hikma-2024-02-26/  

2. Merck’s Bridion Could Face Generic Pressure from Hikma Ahead of Patent Expiry Date [Accessed Febraury 27, 2024] https://www.biospace.com/article/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date/  

3. Merck SEC filing [Accessed February 27, 2024] https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/4abbf601-f36f-4016-ae6f-a07650f3b571.pdf  

4. What is Hatch-Waxman White Sheet [Accessed February 27, 2024] https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/D-F/Fact-Sheet_What-is-Hatch-Waxman_June-2018.pdf