Nine months after Humira lost U.S. exclusivity, biosimilars held four percent of the market. AbbVie’s Humira still controlled ninety-six percent […]

In 2023, Mylan filed an inter partes review against Novo Nordisk’s U.S. Patent No. 8,536,122, the compound patent covering semaglutide,

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