FDA Approves Actavis Generic

Actavis, Inc. ( ACT - Analyst Report ) recently gained US Food and Drug Administration (FDA) approval for its generic version of Suboxone (buprenorphine HCl and naloxone HCl dihydrate SL tablets, 2 mg/0.5 mg and 8 mg/2 mg).

The company intends to launch its generic version of Suboxone immediately. Suboxone, which is indicated for the maintenance treatment of opioid dependence, posted sales of about $625 million in the US for the 12 months ending Dec 31, 2012. The sales data is as per IMS Health.

Actavis Pharma, the company’s global generics business, is expected to post revenues of $6.3 billion - $6.5 billion in 2013. The segment had posted sales of $4.4 billion in 2012, up 32%.

Actavis is the third largest player in the global generics market and has a presence in more than 60 countries. As of Dec 31, 2012, Actavis had more than 185 Abbreviated New Drug Applications (ANDAs) pending FDA approval. These include 49 first-to-file opportunities of which 33 could be exclusive first-to-files.The company intends to launch its generic version of AstraZeneca’s ( AZN - Analyst Report ) Pulmicort Respules in the second quarter of 2013. While Actavis expects an additional competitor for generic Concerta to enter the market in the first quarter of 2013 and a second competitor later this year, it does not expect any competition for its generic versions of Lidoderm and Adderall XR until 2014.

Actavis currently carries a Zacks Rank #3 (Hold). Other generic players like Mylan ( MYL - Analyst Report ) currently look better positioned with a Zacks Rank #2 (Buy). Meanwhile, in the pharma space, Avanir Pharmaceuticals, Inc. ( AVNR - Snapshot Report ) has a Zacks Rank #2.