What's the status of generic Vascepa approvals?
Generic Vascepa, a highly anticipated treatment for high triglycerides, has been in the making for several years. However, its development has been surrounded by patent disputes and regulatory hurdles. As of the latest updates from the FDA, the first generic Vascepa applicant, Zydus Pharmaceuticals (USA) Inc., received a tentative approval in April 2023 [1].
When can we expect generic Vascepa on the market?
Although Zydus has received tentative FDA approval, this step does not guarantee immediate market availability. According to the FDA, the applicant must now finalize its manufacturing process, label requirements, and other documentation before receiving final approval. It's essential to note that these steps can take several months to a year or more to complete [1].
Why are companies challenging the Vascepa patent?
The main patent challenge surrounding Vascepa revolves around its unique active pharmaceutical ingredient (API), icosapent ethyl (IPE). Amarin Pharma, the manufacturer of Vascepa, initially held this patent, which would have protected the API until 2025 [2]. However, the FDA's decision to grant tentative approval to generic applicants has set the stage for an accelerated entry of generics into the market.
What will happen when the exclusivity period expires?
By law, the patent holder is granted exclusivity for a specific period, usually 5-7 years. Once this exclusivity expires, the first generic applicant to win FDA approval can bring the generic version to market [3]. It is expected that multiple generic companies will launch their versions of Vascepa upon approval, which may further increase market competition and prices.
Can biosimilars enter the market before patent expiry?
Biosimilars, which are biologic equivalents of branded medications, can be filed for approval concurrently with branded products. However, biosimilars often require separate clinical and regulatory assessments, leading to a slightly longer pathway to market. Given the patent challenges surrounding Vascepa, biosimilar entrants might experience similar delays and market entry timing, pending FDA evaluations [4].
References:
[1] FDA (2023). Tentative Approval: Zydus Pharmaceuticals (USA) Inc. - Icosapent Ethyl Capsules.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212495Orig1s000TentatvieApprov.pdf
[2] Amarin Pharma. (2020). Amarin Announces Settlement of Litigation with Icosapent Ethyl Patent Litigation.
[3] Patent Act. U.S.C. § 154 (2018).
[4] FDA (2020). Biosimilar Overview.
*Sources cited are hyperlinked as necessary and can be accessed by the reader.*