Eight of Teva’s nine Copaxone patents expired in May 2014. The first FDA-approved generic, Sandoz’s Glatopa, didn’t reach a pharmacy […]

In March 2022, the first generic version of Bristol Myers Squibb’s cancer drug Revlimid reached U.S. pharmacies. It launched at

GSK’s Advair lost its core patent in 2010. Fourteen years later the inhaler was still bringing in £863 million —

In May 2023, the Supreme Court unanimously threw out two Amgen patents that, on their face, covered every antibody that

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