Full Press Release Details
Court Affirms Validity of Collegium's Belbuca Patents
- Ruling bars ANDA filer Alvogen from
entering market until 2032 patent expiry -
Mass., December 22, 2022 -- 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," said Shirley Kuhlmann, General Counsel and Chief Administrative
Officer of Collegium.
About Collegium Pharmaceutical, Inc.
is a diversified, specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.
Collegium's headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company's website
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that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations.
Actual results may differ materially from management's expectations and such forward-looking statements in this press release could
be affected as a result of various important factors, including risks relating to, among others, the outcome of any current or future
patent infringement litigation that may be brought by or against us, and the regulatory status of our products and their generic competitors.
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