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Oracea ruling leaves Amneal waiting years

Amneal Pharmaceuticals has received a mixed verdict in patentinfringement proceedings with Galderma Laboratories over eight US patents shielding Oracea (doxycycline) 40mg capsules. The ruling means Amneal is forbidden from obtaining final abbreviated new drug application (ANDA) approval until at least one asserted patent expires in December 2025.

Amneal Pharmaceuticals has received a mixed verdict in patentinfringement proceedings with Galderma Laboratories over eight US patents shielding Oracea (doxycycline) 40mg capsules. The ruling means Amneal is forbidden from obtaining final abbreviated new drug application (ANDA) approval until at least one asserted patent expires in December 2025.

Delaware District Judge Leonard Stark handed down the ruling to Amneal, finding that the company’s generic infringed claims of five patents and did not infringe claims of the remaining three

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