Actavis Will Relaunch Generic Pulmicort Respules, Following Court Ruling

Actavis plans to immediately relaunch its generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules following a federal appeals court decision upholding a lower court ruling that invalidated the brandmaker’s patent on the drug.

On May 7, the U.S. Court of Appeals for the Federal Circuit affirmed a New Jersey district court’s decision that Pulmicort’s (budesonide inhalation suspension) ’834 patent is invalid. The appellate court also dissolved a March 12 injunction preventing Actavis (formerly Watson) from distribution of its generic version of the drug.

Actavis launched generic Pulmicort in February after the district court found the patent to be invalid. However, AstraZeneca appealed, and sales were halted on Feb. 17 when the appellate court granted a temporary injunction in the case, Astrazeneca v. Breath Limited, Apotex Corp., Apotex, Inc., Sandoz Inc., and Watson Laboratories.

Actavis’ ANDA for generic Pulmicort won FDA approval in August 2012.

Actavis’ generic isn’t Pulmicort’s first competition. Teva has marketed its own generic version of Pulmicort since 2009 under an exclusive licensing agreement signed with the brandmaker in 2008 to settle patent infringement litigation. In 2014, total U.S. brand and generic sales of the drug were roughly $1.2 billion.

AstraZeneca spokeswoman Michele Meixell says the company is disappointed in the court’s decision and is considering legal options. — Jonathon Shacat