The company had received approval for its Abbreviated New Drug Application (ANDA) from the US Food & Drug Administration (:FDA) in August 2012.
Subsequently, Dr. Reddy’s launched its generic version of Toprol XL tablets (25 mg, 50 mg, 100 mg and 200 mg) in the US on September 11, 2012.
Toprol XL is marketed for the treatment of hypertension, angina pectoris, heart failure and disturbances caused by cardiac rhythm, maintenance treatment following myocardial infarction and migraine prophylaxis.
According to IMS Health, US branded and generic sales of Toprol XL were approximately $1.13 billion for the twelve months ended June 30, 2012.
Currently, Par Pharmaceutical Companies Inc. (PRX) markets the authorized generic version of AstraZeneca’s Toprol XL in the US. Apart from this, generic versions of Toprol XL are also marketed by Mylan Inc. (MYL) and Watson Pharmaceuticals Inc. (WPI).
We note Dr. Reddy’s has had quite a few generic launches this year. In August 2012, it launched its generic version of Merck & Co.’s (MRK) blockbuster asthma and allergy drug Singulair (montelukast) -- tablets (10 mg) and chewable tablets (4 mg & 5 mg). Singulair lost patent exclusivity in the US in August 2012.
Dr. Reddy’s also launched a generic version of Pfizer Inc.’s (PFE) blockbuster cholesterol drug, Lipitor. Other recent launches include Dr. Reddy’s generic version of Roche Holdings Ltd.’s (RHHBY) Boniva, GlaxoSmithKline’s (GSK) Requip and Novartis AG’s (NVS) over-the-counter (:OTC) drug, Prevacid.
Currently, we have a Neutral recommendation on Dr. Reddy’s. The stock carries a Zacks #3 Rank (short-term Hold rating).
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