Actavis' Generic Pulmicort on Hold until Final Verdict - Analyst Blog
Actavis ACT announced that the U.S. Court of Appeals for the Federal Circuit has granted AstraZeneca's AZN request for an injunction pending the latter’s appeal in relation to further distribution of the generic version of Pulmicort Respules (0.25 and 0.5 mg). Pulmicort Respules is approved as a maintenance treatment to control and prevent asthma symptoms in children aged between 12 months and 8 years.
As per the court’s ruling, Actavis' sale of the generic Pulmicort has been enjoined pending the resolution of AstraZeneca's appeal before the Court. The restraining order does not include the product shipped prior to its issuance. The Court has set an expedited briefing schedule for the appeal which is expected to be concluded within 33 days.
Last month, Actavis' sales of generic Pulmicort were enjoined following a temporary injunction granted by the U.S. Court of Appeals for the Federal Circuit. Earlier that month, the U.S. District Court for the District of New Jersey ruled that the patent (Patent No. 7,524,834) protecting AstraZeneca’s Pulmicort Respules in the U.S. was invalid and denied AstraZeneca’s request for a permanent injunction. This was followed by the immediate launch of Actavis’ generic version of Pulmicort.
We believe the news of the injunction on Actavis’ generic Pulmicort Respules is disappointing considering the drug’s market share in the U.S. The drug recorded annual branded and generic sales of approximately $1.1 billion in the U.S. for the 12 months ended Jun 30, 2014.
Currently, Teva Pharmaceutical Industries Ltd.’s TEVA generic Pulmicort Respules is the only generic available in the market following its licensing agreement with AstraZeneca.
Actavis currently carries a Zacks Rank #2 (Buy). Another favorably ranked stock in the health care sector is Impax Laboratories Inc. IPXL carrying a similar rank.
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