Actavis plc (ACT - Free Report) confirmed that it is seeking FDA approval for its generic version of Gilead Sciences, Inc.'s (GILD - Free Report) Letairis (5 mg and 10 mg). Letairis is approved for the treatment of pulmonary arterial hypertension.
Gilead and Royalty Pharma Collection Trust have filed a patent infringement lawsuit against Actavis in the U.S. District Court for the District of Delaware in order to prevent Actavis from commercializing its generic version of Letairis prior to the expiration of U.S. Patent No. RE42,462. With the lawsuit being filed under the provisions of the Hatch-Waxman Act, the FDA cannot grant final approval to Actavis’ generic version for up to 30 months from the date the notice was received by claimants about the abbreviated new drug application (ANDA) filing or until final resolution of the matter before the court, whichever occurs first.
Actavis believes it may be the first to file an ANDA for a generic version of Letairis – this means that the company would be entitled to 180 days of generic market exclusivity if the FDA approves the ANDA. As per IMS Health, Letairis global sales were $595 million for the 12 months ended Dec 31, 2014.
Actavis enjoys a strong position in the generic market. The company’s North American Generics segment generated revenues of $4.17 billion in 2014, reflecting an increase of 7%. In Mar 2015, the company had 230 ANDAs pending approval with the FDA – this includes 70 first-to-file applications.
Meanwhile, Actavis completed the acquisition of Botox maker Allergan last month. With this acquisition, Actavis, which was previously known for its strong presence in the generics market, finds itself in the company of the top 10 pharmaceutical firms across the world based on sales. The combined company is expected to generate pro forma revenues of more than $23 billion in 2015.
Actavis intends to adopt Allergan as its corporate name, pending shareholder approval in 2015.
Actavis currently carries a Zacks Rank #2 (Buy). Some other favorably ranked stocks in the health care sector include Akorn, Inc. (AKRX - Free Report) and Mallinckrodt (MNK - Free Report) . Both hold a Zacks Rank #1 (Strong Buy).