Posts Tagged: paragraph IV certification


Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
By Zachary Silbersher
2 years ago 3

Bristol-Myers Squibb, Pfizer file ANDA lawsuits against makers of generic Eliquis

American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a …
By Steve Brachmann
3 years ago 0

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug …
By Gene Quinn & Steve Brachmann
3 years ago 0

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants …
By Steve Brachmann
3 years ago 0

Eli Lilly prevails in divided infringement Alimta® patent case

The United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement …
By Gene Quinn
4 years ago 1

Senate Bill Would Prevent Reverse Pharma Payments

The Patent Docs are reporting that on February 3, 2009, Senator Herb Kohl (D-WI) introduced legislation into the Senate titled the Preserve Access to Affordable Generics Act, which would …
By Gene Quinn
11 years ago 1