FDA has updated Paragraph IV patent certifications which includes P-IV for Bristol–Myers 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|
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|
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.|
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.