Zydus Pharmaceuticals won a patent battle over Shire’s ulcerative colitis drug Lialda (mesalamine), with the U.S. Court of Appeals for the Federal Circuit ruling that Zydus’ proposed generic version of Lialda does not infringe upon Shire’s patent covering the drug.
“We welcome this decision, which is a positive step and will help us further our mission of making available high-quality, affordable generic products to our customers and their patients,” Pankaj R. Patel, chairman and managing director at Zydus Cadila, said in a press release.
Mesalamine is a compound that has been around for years and is not patent protected. Shire’s patent covers the release mechanism, allowing the drug to travel through the intestines untouched until it reaches the colon. U.S. Patent No. 6,773,720 protects this delayed release mechanism.
The patent feud has been going on for seven years now. Zydus, owned by India’s Cadila Healthcare, was the first company that questioned Shire’s rights to Lialda when they filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration (FDA) for a generic version of Lialda in 2010, according to reporting by Law360.
In 2016, the U.S. District Court for the District of Delaware ruled in favor of Zydus, claiming the proposed generic did not infringe on the patent, as the expert testimony did not indicate that the proposed molecule had the same structure.
Shire vowed to appeal the decision, claiming Zydus’ product infringes on its patent, and said it would defend its intellectual property rights, according to a press release issued at the time.
Zydus has not shared any information about when their generic product might be expected on the U.S. market, or about communications with the FDA on the ANDA submission.
Lialda is currently approved for the induction of remission in patients with active mild-to-moderate ulcerative colitis. It can also be used for the maintenance of remission.
Mesalamine is present in other drug formulations, including Apriso, Asacol HD, Delzicol, and Pentasa. Despite it being an older drug, researchers do not really know how it acts to treat ulcerative colitis. However, studies do show that it impacts inflammatory pathways and acts as an antioxidant.
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