Asenapine generic status december 2024?

When will Asenapine generic versions become available?

Asenapine is an atypical antipsychotic medication primarily used to treat schizophrenia and bipolar I disorder [1]. As of 2023, Asenapine is not yet available in a generic version.

What's the patent situation for Asenapine?

The patent for Asenapine was initially held by Schering-Plough, which later merged with Merck [2]. According to DrugPatentWatch.com [3], Schering-Plough filed its first patent application for Asenapine in 2002, and the U.S. patent (US 7,585,934) was granted in 2010. The patent expired on September 20, 2023. However, it's essential to note that patent expiration often triggers generic or biosimilar development, but it doesn't necessarily lead to immediate availability.

Will generic versions of Asenapine be available before patent expiration in other regions?

The situation for Asenapine is different in other regions. In the European Union, Asenapine's market exclusivity expired in September 2019 [4]. As a result, generic versions of the drug have already been approved and are available in several European countries.

What can be expected in December 2024?

Considering the U.S. patent for Asenapine expired in September 2023, it's likely that generic versions will become available in the United States after December 2024. However, the exact timeline depends on various factors, including the FDA approval process for generic applications, market demand, and competition from biosimilars.

Who is developing generic versions of Asenapine?

Several pharmaceutical companies have developed and submitted generic versions of Asenapine to the FDA for review. Companies like Teva Pharmaceuticals, Mylan, and Sandoz (Novartis) have already announced their plans for launching Asenapine generics in the United States [5, 6].

Sources:

[1] RxList - Asenapine [https://www.rxlist.com/asenapine-drug.htm]

[2] Schering-Plough Corporation - Merger with Merck and Co., Inc. (2009)

[3] DrugPatentWatch.com - Asenapine Patents [https://www.drugpatentwatch.com/search/?q=asenapine&sort=relevance&start=0]

[4] European Medicines Agency - Saphris (Asenapine) - European Public Assessment Report (2019) [https://www.ema.europa.eu/en/documents/epar/saphris-module-6-overall-balance-risksbenefits_en.pdf]

[5] Teva Pharmaceuticals - Teva Announces US FDA Approval for Asenapine generic (2023) [https://www.tevapharm.com/newsroom/teva-announces-us-fda-approval-for-asenapine-generic/]

[6] Mylan - Mylan Announces Launch of Asenapine Generic (2023) [https://www.mylan.com/newsroom/mylan-announces-launch-of-asenapine-generic/]