Independently, Watson Pharmaceuticals, Inc (CORONA, California); Barr Pharmaceuticals, Inc (MONTVALE, New Jersey); and Teva Pharmaceutical Industries Ltd (JERUSALEM, Israel); have announced launches of the generic version of Merck & Co, Inc's Fosamax® (alendronate sodium) tablets following expiration of market exclusivity.
Watson, a leading specialty pharmaceutical company and the authorized distributor of branded generic Fosamax, has initiated distribution of alendronate sodium 35 mg and 70 mg once-weekly tablets. Under the terms of a supply agreement, Merck will manufacture and supply alendronate sodium tablets to Watson, which will market, sell, and distribute the product in the US under the brand name. Merck will receive a share of the profits from Watson's US sales.
Barr has launched a generic version of Fosamax 70 mg tablets after receiving final US FDA approval, following the earliest expiring patents of pediatric exclusivity. The company is entitled to share 180 days of marketing exclusivity—prohibiting generic competition—for its 70 mg alendronate sodium product, other than the authorized generic distributed by Watson, and Teva, with which Barr shares exclusivity. In addition, Barr has obtained favorable resolutions with other patents listed for the drug.
Teva, among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world, has launched its generic version of Fosamax 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg.
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