Galderma sues Lupin over Oracea generic
Galderma Laboratories has sued Lupin Pharmaceuticals alleging that it plans to manufacture and sell a generic version of Oracea (doxycycline) prior to the expiration of key patents.
The complaint was filed in the US District Court for the District of Delaware on Friday, December, 3.
Galderma holds the new drug application for Oracea 40mg capsules and is the exclusive distributor of the drug in the US.
Oracea is an antibiotic used in the treatment of pneumonia, acne, chlamydia, Lyme disease and cholera.
It is also the exclusive license holder of the six patents-in-suit, which are owned by TCD Royalty Sub, a unit of DRI Healthcare Trust. The patents have adjusted expiry dates between April 2024 and December 2027.
Lupin filed an abbreviated new drug application (ANDA) to manufacture a generic of the 40mg Doxycycline capsule prior to the expiration of six of the patents.
It sent a letter dated October 21, 2021, notifying the plaintiffs that it had filed the ANDA and was seeking approval of the generic.
Both Galderma and TCD Royalty Sub are seeking injunctions enjoining Lupin for manufacturing and selling the generic drug in the US.
Prior cases
In prior litigation at the court, several claims of the ‘532 patent were held to be infringed by a Lupin ANDA and not invalid in a judgment dated July 2012, which was affirmed by the US Court of Appeals for the Federal Circuit in 2013.
In 2011, Galderma also filed suits against fellow generic manufacturers Sandoz, Impax, and Amneal Pharmaceuticals in the Delaware court, which had also sought approval with the FDA to manufacture 40mg capsules of the drug.
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