Generics for Otezla® to be out in the United States in February 2028

Amgen’s oral phosphodiesterase-4 (PDE-4) inhibitor – Otezla® (Apremilast) is approved in the United States for the treatment of psoriatic arthritis, moderate to severe plaque psoriasis as well as oral ulcers associated with Behçet’s disease. The drug gained its first approval from the U.S. Food & Drug Administration (FDA) in March 2014. As per Amgen’s Q2 2023 financial results, the drug sales increased 1% year-over-year, driven by 2% volume growth¹.

Originally owned by Celgene Corporation, Otezla®’s product patent (US7427638) is set to expire in November 2024, however, a patent term extension of 1186 days has extended its exclusivity until February 2028. Amgen acquired Celgene Corporation in August 2019 by paying $13.4 billion in cash and thus acquired all the rights for its oral, non-biologic treatment for psoriasis and psoriatic arthritis – Otezla®².

In 2021, in a Hatch-Waxman Act patent infringement case, Amgen asserted five patents – US7427638, US8455536, US10092541, US7893101, US8093283 – against Dr. Reddy’s Laboratories, Sandoz, and Zydus Pharmaceuticals who sought approval from the U.S. FDA to market generic versions of Apremilast. These patents covered stereomerically pure Apremilast, associated methods and dosages for using stereomerically pure Apremilast to treat psoriasis, and various crystalline forms of Apremilast³.

In a recent judgement in April 2023 by the U.S. Court of Appeals for the Federal Circuit, the validity of US7427638 and US7893101 was confirmed, however, US10092541 was declared obvious in light of prior art. Accordingly, Amgen managed to fend off the generic competition for five years as the generic applicants have faced a permanent injunction from making, using, selling, offering to sell, or importing each of their generic versions of Otezla® until February 2028.

ANDA applicants like Sandoz, Glenmark, Mankind Pharma, Annora, Zydus Pharma and Alkem Labs who have been awarded tentative approvals by the U.S. FDA will now have to wait until early 2028 to bring their generic versions to the market.

References:

1. https://investors.amgen.com/news-releases/news-release-details/amgen-reports-second-quarter-financial-results#:~:text=Otezla%C2%AE%20(apremilast)%20sales%20increased,launched%20topical%20and%20systemic%20competitors
2. https://www.amgen.com/newsroom/press-releases/2019/08/amgen-to-acquire-otezla-for-134-billion-in-cash-or-approximately-112-billion-net-of-anticipated-future-cash-tax-benefits
3. https://cafc.uscourts.gov/opinions-orders/22-1147.OPINION.4-19-2023_2113208.pdf