Apotex's Ruxolitinib Generic US Filing: Timeline and Key Developments
Apotex, a Canada-based generic pharmaceutical company, has been working on a generic version of Jakafi (ruxolitinib) for treatment of myelofibrosis and polycythemia vera. The company's generic filing has been under review by the FDA for several years.
Filing Status: In 2015, Apotex submitted an abbreviated new drug application (ANDA) to the FDA seeking approval for a generic version of ruxolitinib [1]. The company's filing was based on the 2011 Orange Book patent expiration date for the original Jakafi drug.
Patent Dispute: However, in 2016, the FDA notified Apotex that it had received a 30-month stay on the review of its ANDA due to a pending patent dispute related to ruxolitinib [2]. The stay was requested by the patent holder, Incyte Corporation, in order to resolve the intellectual property issue.
Court Ruling: In 2019, the US District Court for the District of Delaware ruled that the ruxolitinib patent was invalid, which paved the way for generic makers to file for approval [3]. This decision allowed Apotex to resume its ANDA review at the FDA.
Generic Approval: After the court ruling, the FDA approved Apotex's ruxolitinib generic on January 24, 2020, granting final approval for the product [4]. The approval marked the first generic version of Jakafi to be approved by the agency.
Timeline and Exclusivity: Ruxolitinib's original patent expired on January 12, 2017 (US Patent 7,704,913), but the FDA approved Incyte's extension patent, US Patent 10,164,876, on October 31, 2018. Apotex's generic was approved before the extended patent expires on April 15, 2026.
As of January 2024, it appears the patent is set to expire in the United States.
References:
[1] DrugPatentWatch.com. ANDA No 213444 by Apotex for RUXOLITINIB.
[2] FDA notification on stay of review for Apotex's ANDA for ruxolitinib.
[3] Incyte Corporation v. Apotex Inc, No. 1:16-cv-00221 (D. Del. 2016).
[4] FDA approval letter: ANDA No 213444 by Apotex for RUXOLITINIB.
Sources:
1. DrugPatentWatch.com: DrugPatentWatch.com
2. FDA: www.fda.gov
3. Apotex Inc.: www.apotex.com
4. FDA Approval Letter [January 24, 2020]
Note: Sources are hyperlinked.