Collegium settles with Teva over Xtampza ER patent litigation

US specialty pharma firm Collegium Pharmaceutical’s (Nasdaq: COLL) shares closed up 4.7% at $20.82 on Wednesday, after it announced a settlement agreement with the US subsidiary of Israel’s Teva Pharmaceutical Industries (NYSE: 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 (oxycodone) ER, prior to the expiration of Collegium’s applicable patents.

Under the terms of the settlement, which is subject to review by the US Federal Trade Commission and the US Department of Justice, Collegium will grant Teva a license to market its generic version of Xtampza ER in the USA beginning on or after September 2, 2033 (subject to US FDA approval, and acceleration under certain circumstances). Xtampza ER generated net product revenues of $33.6 million the second quarter of 2020.

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.