12/11/2024

Aachen, Germany, 11 December 2024 – Grünenthal GmbH (“Grünenthal”), a pharmaceutical company specialized in treatment of pain, today announced that Grünenthal has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (“Teva”) resolving their patent litigation in the U.S. in response to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval by the US. Food and Drug Administration (“FDA”) to market a generic version of Nucynta^® ER (tapentadol).

Grünenthal licensed the U.S. rights to Nucynta and Nucynta ER to Collegium Pharmaceutical Inc. in January 2020.

Under the terms of the settlement agreement, Teva cannot sell a generic version of Nucynta^® ER in the U.S. until July 1, 2027 (subject to U.S. FDA approval) or earlier under certain circumstances.

The litigation filed in the U.S. District Court for the District of New Jersey has been dismissed.

About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all our activities and efforts on working towards our vision of a World Free of Pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion.

More information: www.grunenthal.com and Grünenthal Report 2023/24

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