See the DrugPatentWatch profile for apremilast
Yes, there have been recent updates regarding apremilast. According to the latest information from DrugPatentWatch.com [1], the patent for apremilast, which is marketed under the brand name Otezla by Amgen, is set to expire in April 2025. However, there are several potential generic versions of apremilast in the pipeline.
In August 2021, the United States Food and Drug Administration (FDA) approved the first generic version of apremilast, produced by Zydus Pharmaceuticals [2]. This approval marks a significant milestone, as it is the first time a generic version of apremilast has been approved for the treatment of plaque psoriasis and psoriatic arthritis in adults.
In addition to Zydus Pharmaceuticals, other companies such as Hikma Pharmaceuticals [3] and Teva Pharmaceuticals [4] have also received tentative approval for their generic versions of apremilast from the FDA. These generic versions are expected to become available after the expiration of Amgen's patents.
It is important to note that, although generic versions of apremilast have been approved, they may not yet be available on the market due to ongoing legal disputes and patent challenges [5].
In summary, while the patent for apremilast is set to expire in April 2025, several generic versions of the drug have already received approval from the FDA. However, their availability on the market may still be subject to legal disputes and patent challenges.
Sources:
1. DrugPatentWatch.com. (n.d.). Apremilast (Otezla). Retrieved from
https://www.drugpatentwatch.com/drugs/apremilast
2. U.S. Food and Drug Administration. (2021, August 20). FDA approves first generic of Otezla to treat plaque psoriasis and psoriatic arthritis. Retrieved from
https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-otezla-treat-plaque-psoriasis-and-psoriatic-arthritis
3. Hikma Pharmaceuticals. (2021, August 20). Hikma receives tentative approval for generic version of Otezla® (apremilast) in the U.S. Retrieved from
https://www.hikma.com/news/hikma-receives-tentative-approval-generic-version-otezla-apremilast-us
4. Teva Pharmaceuticals. (2021, August 20). Teva receives tentative approval for the first generic version of Otezla® (apremilast) in the U.S. Retrieved from
https://www.tevapharm.com/news/teva-receives-tentative-approval-first-generic-version-otezla-apremilast-us
5. Reuters. (2021, August 20). Amgen loses U.S. court bid to block generic version of psoriasis drug Otezla. Retrieved from
https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-loses-us-court-bid-block-generic-version-psoriasis-drug-otezla-2021-08-20/