In 2023, Mylan filed an inter partes review against Novo Nordisk’s U.S. Patent No. 8,536,122, the compound patent covering semaglutide, […]
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On November 30, 2011, Ranbaxy Laboratories was supposed to be the only company selling a generic version of Lipitor. It
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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
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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
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A Paragraph IV certification feels like an ambush when a generic company files it. It rarely is one for the
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Ranbaxy won the most valuable prize in generic pharmaceuticals — first-to-file exclusivity on generic Lipitor — while two of its
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Catalyst Pharmaceuticals sells a drug for Lambert-Eaton myasthenic syndrome, a disease that affects roughly 3 people per million. In the
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