Vascepa's Original FDA Approval Timeline
Vascepa (icosapent ethyl) from Amarin received FDA approval for cardiovascular risk reduction on December 13, 2019, after a standard review process for its supplemental New Drug Application (sNDA). The PDUFA target action date was met without delay.[1]
Any Post-Approval Review Delays?
No FDA review delays have been reported for Vascepa's major approvals or label expansions. The 2019 CV outcome approval followed the planned timeline, supported by the REDUCE-IT trial data submitted in 2018. A 2020 update for expanded indication (without statins) also proceeded on schedule.[2]
Why the Question Comes Up Now
Recent scrutiny ties to Amarin's patent disputes and ANDA challenges, not FDA reviews. Generic challengers like Dr. Reddy's and MSN target Vascepa patents, with litigation ongoing, but this affects market exclusivity, not FDA timelines. The FDA has not flagged any review holds.[3]
When Do Patents Expire?
Vascepa's key patents, including composition-of-matter, expire between 2030 and 2036. DrugPatentWatch lists 24 patents, with the earliest expiry in October 2030. No FDA review delays impact this.[4]
Generic Entry Outlook
FDA has received multiple ANDA filings for generics, but approvals await patent settlements or litigation outcomes. No delays in FDA's review of these ANDAs are public; the bottleneck is IP disputes.[4][5]
[1]: FDA.gov - Vascepa Approval Letter (Dec 13, 2019)
[2]: Amarin Investor Update (Jan 2020)
[3]: FDA Paragraph IV Patent Certifications List
[4]: DrugPatentWatch.com - Vascepa Patents
[5]: Amarin Q2 2023 Earnings Call Transcript