Collegium Announces Settlement with Teva Resolving Xtampza® ER Patent Litigation

Rhea-AI Summary

Collegium Pharmaceutical (Nasdaq: COLL) reached a settlement with Teva Pharmaceutical regarding patent litigation over the generic version of Xtampza ER. The agreement allows Teva to market its generic version starting September 2, 2033, pending FDA approval. The settlement confirms that Teva's proposed products infringe on Collegium's patents, which are valid and enforceable. Collegium's intellectual property portfolio includes 19 patents for Xtampza ER, valid through 2036, asserting the company's commitment to innovation in pain management.

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• Settlement with Teva reinforces the strength of Collegium's intellectual property portfolio.
• 19 Orange Book-listed patents for Xtampza ER extending through 2036, ensuring market protection.

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• None.

STOUGHTON, Mass., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today announced that it has reached a settlement agreement with Teva Pharmaceutical USA, Inc. (Teva) that resolves patent litigation brought in response to Teva’s Abbreviated New Drug Application (ANDA), seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents.

Pursuant to the terms of the settlement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, Collegium will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033 (subject to U.S. FDA approval, and acceleration under certain circumstances). As a result of the settlement, Teva has agreed to a consent judgment confirming that its proposed generic products infringe Collegium’s asserted patents and that those patents are valid and enforceable with respect to Teva’s proposed generic products. Additional details regarding the settlement are confidential.

“As a company committed to being the leader in responsible pain management, we seek to deliver scientific innovation through differentiated products for people suffering from pain. We are pleased with the outcome of the ANDA settlement with Teva because it highlights the value of that innovation in the context of the Xtampza ER franchise,” said Shirley Kuhlmann, Executive Vice President and General Counsel of Collegium. “The resolution of this litigation reinforces the strength of Collegium’s intellectual property portfolio, which includes 19 Orange Book-listed patents covering Xtampza ER with expiries through 2036, and our commitment to innovation in responsible pain management.”

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company committed to being the leader in responsible pain management. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the company’s website at www.collegiumpharma.com.

Contact:
Alex Dasalla
adasalla@collegiumpharma.com

FAQ

What is the significance of the settlement between Collegium Pharmaceutical and Teva?

The settlement allows Teva to market a generic version of Xtampza ER starting September 2, 2033, confirming the validity of Collegium's patents and protecting its market position.

When can Teva market its generic version of Xtampza ER?

Teva can market its generic version of Xtampza ER on or after September 2, 2033, subject to FDA approval.

How many patents does Collegium hold for Xtampza ER?

Collegium holds 19 Orange Book-listed patents for Xtampza ER, with expiries extending through 2036.

What confirms the validity of Collegium's patents in the settlement with Teva?

Teva has agreed to a consent judgment that confirms its proposed generic products infringe Collegium’s asserted patents and that these patents are valid and enforceable.