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Orexo receives paragraph IV Notice Letter in the US

Orexo has received a “paragraph IV” patent certification notice from Sun Pharmaceutical Industries Limited.

The Notice Letter advises Orexo of Sun’s filing of an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) seeking approval of generic versions of ZUBSOLV before the expiration of Orexo’s patents listed in the Orange Book. Orexo currently has five patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

“We are working closely with our external lawyers to review the details of this Notice Letter and will decide on our response within the statutory timeline of 45 days from receipt of the notice. We intend to vigorously enforce our intellectual property rights around ZUBSOLV. While every case is unique, we will benefit from the work and efforts from previous cases. ZUBSOLV is important to Orexo, and we are confident our new digital therapies and pharmaceutical pipeline, including four US product launches in the coming two years, represent a significant value opportunity and will not be impacted by this and our other legal process,” says Nikolaj Sørensen, Orexo’s president and CEO.

Read more: Interview – Nikolaj Sørensen, CEO of Orexo

Photo: Jenny Öhman/Nordic Life Science