Actavis Facing Patent Infringement Lawsuit Over Uceris ANDA

Santarus and Cosmo Technologies have sued Actavis charging its Paragraph IV ANDA against Santarus’ ulcerative colitis therapy Uceris infringes the drug’s patents.

NDA holder Santarus and patent owner Cosmo filed their complaint Feb. 19 in U.S. district court in New Jersey, seeking to bar Actavis from marketing its version of Uceris (budesonide) until the last of the drug’s 9 mg version patent protection runs out.

Five of the drug’s six patents — the ‘651, ‘943, ‘273, ‘888 and ‘799 — expire in 2020, while the last, the ‘064, enjoys protection until 2031, according to the Orange Book.

Actavis confirmed the patent challenge last Tuesday.

Actavis first notified Santarus and Cosmo of the Paragraph IV ANDA filing in a Jan. 5 letter, according to the complaint, Cosmo Technologies Limited et al v. Actavis Laboratories Fl, Inc.

Complicating the lawsuit is the parties’ inability thus far to access Actavis’ information relating to development and manufacture of the proposed generic, the complaint says. That information would help in determining which specific patents and claims to bring against Actavis.

A wholly owned subsidiary of Salix Pharmaceuticals, Santarus launched Uceris in February 2013, a month after getting FDA approval. The therapy brings in an estimated $144 million in annual sales, according to SEC filings.

Actavis did not respond to a request for comment by press time. — Bryan Koenig