Dr. Reddy’s Laboratories (RDY) recently announced the launch of its generic version of Merck & Co’s (MRK) blockbuster asthma and allergy drug Singulair (montelukast) following the receipt of US Food & Drug Administration (:FDA) approval for its Abbreviated New Drug Application (ANDA).
Dr. Reddy’s launched its generic version of Singulair tablets (10 mg) and chewable tablets (4 mg & 5 mg) in the US on August 6, 2012. Singulair is marketed for the chronic treatment of asthma symptoms and relieving symptoms of allergic rhinitis in both adults and children.
According to IMS Health, US branded sales of Singulair tablets and chewable tablets were approximately $3.6 billion and $1.14 billion, respectively, for the twelve months ended March 31, 2012.
Earlier this month, Singulair lost patent exclusivity in the US. Notably, Mylan Inc. (MYL) also launched its generic version of Singulair tablets (10 mg) and chewable tablets (4mg &5 mg) following FDA approval.
Dr. Reddy’s had quite a few generic launches this year. In July 2012, it launched its generic version of Pfizer Inc.’s (PFE) blockbuster cholesterol drug, Lipitor. The FDA had approved the company’s ANDA for its generic version of Lipitor (10 mg, 20 mg, 40 mg and 80 mg formulations). Lipitor lost patent exclusivity in the US on November 30, 2011.
Dr. Reddy’s also launched a generic version of Roche’s (RHHBY) Boniva tablets for the treatment of osteoporosis in women after menopause. A generic version of Boniva is also currently marketed by Watson Pharmaceuticals Inc. (:WPI).
We currently have a Neutral recommendation on Dr. Reddy’s. However, the stock carries a Zacks #1 Rank (short-term Strong Buy rating). We believe that generic launches will continue to drive revenues at Dr. Reddy’s Global Generics segment, which climbed 32% to $343 million in the second quarter of 2012.
Primary contribution came from both North America and Russia and other CIS (Commonwealth of Independent States) markets (up 38%) followed by India (up 19%) and Europe (up 14%). Growth was mainly driven by new generic launches and an increase in the market share of existing key products.
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