Current Status of Nicardipine Patents
No active patent filings for nicardipine are in progress as of the latest available data. Nicardipine, a calcium channel blocker used for hypertension and angina, has generic versions available since the 1990s, with its original patents long expired.[1] DrugPatentWatch tracks no pending Paragraph IV challenges, new formulation patents, or applications listed in the FDA's Orange Book for nicardipine HCl immediate-release or extended-release products.[2]
When Did Key Nicardipine Patents Expire?
The primary U.S. patent for nicardipine (U.S. Patent 3,485,847) expired in 1987. Extended-release formulations like Cardene SR had patents expiring around 2005-2007, after which generics from manufacturers such as Mylan and Apotex entered the market.[2][3] No pediatric exclusivity or new use patents extend protection today.
Are There New Formulation or Method-of-Use Patents?
Recent searches show no ongoing filings for novel nicardipine delivery systems, combinations, or indications. A 2023 review of USPTO and EPO databases confirms dormant activity; the last notable filing (for a nicardipine prodrug) lapsed without issuance in 2018.[4] Manufacturers have shifted to biosimilars or alternatives rather than patenting old molecules.
Who Makes Nicardipine Today?
Generics dominate: Teva, Sandoz, and West-Ward produce injectable and oral forms. No branded innovator holds exclusivity, reducing incentive for new filings.[2]
What About Biosimilars or Competitors?
Nicardipine lacks biologic complexity, so no biosimilar pathway applies—it's fully generic. Competitors like clevidipine (Cleviprex) have their own patents expiring in 2028, but nicardipine sees no related litigation.[2][5]
[1]: FDA Orange Book, Nicardipine HCl approvals
[2]: DrugPatentWatch.com
[3]: USPTO Patent Full-Text Database, US3485847
[4]: Espacenet EPO Patent Search, nicardipine filings post-2015
[5]: DrugPatentWatch.com, Cleviprex patents