Teva settles patent litigation over ProAir HFA

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Teva settles patent litigation over ProAir HFA

Generics/News | Posted 04/07/2014 0 Post your comment

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

ProAir HFA is an inhalation aerosol indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

As part of the settlement Perrigo and Catalent will gain a licence to sell limited units of Perrigo’s generic version of the product for an initial period beginning 19 December 2016 and lasting until June 2018, when the limits will no longer apply.

The settlement dismisses pending litigation in the US District Court of Delaware in which Teva filed a lawsuit against Perrigo and Catalent in response to the generics companies filing abbreviated new drug applications (ANDAs) with the US Food and Drug Administration. The ANDAs, according to Teva, infringed four of the five patents on ProAir HFA, the last of which expires on 7 September 2028.

ProAir had worldwide sales of US$429 million during 2013, an increase of 2% over sales in 2012.

Teva says there are no other challenges to the patents for ProAir HFA and no further litigation pending. The generics major, which has been at the forefront of patent challenges, also stated that it ‘will continue to vigorously defend its intellectual property rights relating to its products’.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Teva