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

Eli Lilly spent fourteen years and four separate Phase 3 populations trying to make solanezumab work, and the compound never

Teva’s ProAir HFA inhaler illustrates the gap better than any definition can. The active ingredient, albuterol sulfate, went off patent