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Appeals Court Affirms Validity of Collegium’s Belbuca® Patents
December 22, 2022 at 8:00 AM EST
Ruling bars ANDA filer Alvogen from entering market until 2032 patent expiry

STOUGHTON, Mass., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company, today announced that the Federal Circuit has upheld the judgment of the U.S. District Court for the District of Delaware that certain claims of the patents protecting Belbuca® are valid.

In addition to upholding the District Court’s judgment regarding the validity of certain claims in the 8,147,866 patent, expiring in 2027 (the “’866 patent”), and 9,901,539 patent, expiring in 2032 (the “’539 Patent”), the Federal Circuit vacated the District Court’s findings of invalidity with respect to certain claims of the ‘866 patent and the 9,655,843 patent (both expiring in 2027) and remanded such claims for reconsideration by the District Court.

Alvogen conceded infringement of all claims at issue in the litigation, and accordingly, Collegium expects that, by virtue of the Federal Circuit’s decision, Alvogen will be barred from entering the market with its product until 2032.

“We are very pleased with the Federal Circuit’s decision, which reinforces the strength of the patents supporting Belbuca, and we look forward to continuing to supply this innovative and differentiated product to appropriate patients,” said Shirley Kuhlmann, General Counsel and Chief Administrative Officer of Collegium.

https://ir.collegiumpharma.com/news-releases/news-release-details/appeals-court-affirms-validity-collegiums-belbucar-patents