On November 30, 2011, Ranbaxy Laboratories was supposed to be the only company selling a generic version of Lipitor. It […]

The Short Answer A patent’s presence in the FDA Orange Book proves it was submitted and accepted for listing. It

The Short Answer: Under FDA’s interpretation of the Hatch-Waxman Act, “first applicant” status on a Paragraph IV certification is determined

In March 2002, Teva filed an ANDA for generic carvedilol targeting a patent that would not expire for five more

On October 31, 2025, the director of the U.S. Patent and Trademark Office denied institution of thirteen inter partes review

A Paragraph IV certification feels like an ambush when a generic company files it. It rarely is one for the

Ranbaxy won the most valuable prize in generic pharmaceuticals — first-to-file exclusivity on generic Lipitor — while two of its

Catalyst Pharmaceuticals sells a drug for Lambert-Eaton myasthenic syndrome, a disease that affects roughly 3 people per million. In the

On November 7, 2023, the Federal Trade Commission sent warning letters to ten pharmaceutical manufacturers over more than 100 patents