Monday, April 1, 2013

Pulmicort respule patent held invalid - Yet another blow for AstraZeneca

AstraZeneca today announced that the United States District Court for the District of New Jersey ruled that AstraZeneca's US Patent No. 6,598,603 ("the '603 patent"), protecting PULMICORT RESPULES in the US, is invalid. The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834 ("the '834 patent"). 

The United States District Court for the District of New Jersey has ruled that Actavis' generic Version of AstraZeneca's Pulmicort RESPULES (budesonide inhalation suspension) 0.25, 0.5 mg, and 1 mg  vials do not infringe United States Patent No. 7,524,834  (the '834 Patent) and that United States Patent No. 6,598,603 (the '603 Patent) is invalid.  Actavis intends to launch the 0.25 and 0.5 mg products immediately.
Actavis' Abbreviated New Drug Application ("ANDA") for its generic version of Pulmicort RESPULES® in the 0.25 and 0.5 mg strengths received final approval from the U.S. Food and Drug Administration in August 2012.  Actavis' ANDA for the 1 mg strength is still pending.
Pulmicort RESPULES® is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.  For the 12 months ended January 31, 2013, total U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.2 billion.

The decision is limited to the US and has no impact on the validity of patents related to PULMICORT RESPULES in other countries. This decision will not change AstraZeneca's revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in revenue on a constant currency basis (Full Year 2012 PULMICORT RESPULES US sales were $136 million).  In the event that additional generics enter the market, this would materially impact royalties received on sales of Teva's generic version of PULMICORT RESPULES. These royalties represented an annualised value of approximately $260 million in 2012 under the Core Other Income line in the company's annual report and accounts. Subject to additional generics entering the market, our guidance for Core Other Income in 2013 is now that it could be significantly below $600 million. The company still expects core EPS to decline significantly more than revenue in 2013.  
The patents protecting PULMICORT RESPULES expire in 2018, with paediatric exclusivity extending into 2019.

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