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4 October 2016Americas

Depomed wins ANDA case against Actavis and Roxane

US pharmaceutical company Depomed has won a patent case in the US District Court for the District of New Jersey against three filers of Abbreviated New Drug Applications (ANDAs) covering Nucynta (tapentadol).

Following the court’s ruling on September 30, Depomed will have market exclusivity over the painkiller until December 2025.

Jim Schoeneck, president and CEO of Depomed, said in a statement: “We are pleased with the court’s decision as it confirms the validity and strength of the Nucynta patents.”

He added: “We look forward to growing the Nucynta franchise, comprised of two important and highly-differentiated medicines, for at least the next nine years.”

In the ruling, the court found US patent numbers RE39,593 and 7,994,364 to be valid and infringed by Actavis, Roxane Laboratories and Alkem Laboratories.

The patents involved will expire on February 5, 2023 and December 27, 2025 respectively.

The court found a third patent, US number 8,536,130, to be valid but not infringed.

According to a  statement released on September 30, Depomed said it intends to appeal against the decision centring on the ‘130 patent.

Nucynta is used to help relieve moderate to severe short-term pain.

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