Which Nicardipine Formulation Patent?
Nicardipine, a calcium channel blocker used for hypertension and angina, has multiple patents covering formulations like injectables (e.g., Cardene IV). The key U.S. formulation patent is US 8,785,411 ('411 patent), owned by Eclat Pharmaceuticals, protecting the hydrochloride injection formulation.[1]
When Does the '411 Patent Expire?
The '411 patent expires on October 14, 2028. This date accounts for patent term adjustments (PTA) extending the original 20-year term from the February 6, 2008 filing date.[1][2]
Why Does This Matter for Generics?
This expiry opens the door for generic nicardipine hydrochloride injections. No ANDA approvals are listed yet, but challenges via Paragraph IV could shorten effective exclusivity through litigation. Pediatric exclusivity might add 6 months, pushing to April 14, 2029, if granted.[1][3]
Other Relevant Nicardipine Patents
- US 10,259,442 (extended formulation): Expires March 13, 2031.[1]
- US 9,238,027 (oral capsules): Expired December 8, 2020, allowing generics like those from Apotex.[2]
- Earlier patents (e.g., compound patent US RE30,577) expired decades ago.[1]
Check DrugPatentWatch.com for updates on litigation or new filings: DrugPatentWatch Nicardipine Patents.
Who Makes Branded Nicardipine Formulations?
Eclat Pharmaceuticals holds rights to Cardene IV (nicardipine HCl injection). Competitors like Baxter offer similar products under different patents.[1][4]
Sources:
[1]: DrugPatentWatch.com - Nicardipine Patents
[2]: USPTO Patent Full-Text - US 8,785,411
[3]: FDA Orange Book - Nicardipine
[4]: FDA Approved Drug Products