Paragraph IV Patent Certifications

FDA has updated Paragraph IV patent certifications which includes P-IV for  BristolMyers Squibb’s anticoagulant drug Apixaban

Drug Name Dosage Form Strength RLD Date of Submission
Apixaban Tablets 2.5 mg and 5 mg Eliquis 12/28/2016
Ivermectin Cream 1% Soolantra 12/30/2016

Apixaban product info

Apixaban is a Factor Xa inhibitor developed by BMS which received FDA approval in December 2012, marketed under the brand name ELIQUIS. The drug is patented generically and specifically. The following table represents the OB status for Apixaban. NCE is set to expire on Dec 28, 2017.

Patent No Patent Expiration Remarks Remarks
US 6,413,980

Priority: Dec 23, 1998

Publication date: Jul 6, 2000 (PCT of US ‘980)

Dec 22, 2019 Claims Apixaban generically Must be P-III with respect to this patent, as this patent is expiring in 2019.
US 6,967,208

Priority: Sep 21, 2001

December 28, 2026 (including PTE request) Claims Apixaban Specifically Coalition For Affordable Drugs has challenged this patent at PTAB via an IPR, the trial got denied by PTAB.
US 9,326,945 Feb 24, 2031 Claims pharmaceutical composition

There are total 24 DMF’s available for Apixaban.


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