Watson to market authorized generic
Merck’s blockbuster osteoporosis drug Fosamax will lose patent protection tomorrow with the expiration of Orange Book listed US4621077 (which covers method of use for approved indication), losing significant $ 1.6 billion US market to generic competition. Earlier in January, Merck announced to sign a deal for an authorized generic but did not disclose the name of its partner. Finally, it is Watson Laboratories that will be selling the authorized version of Fosamax. Barr Pharmaceuticals and Teva Pharmaceutical Industries are also expected to launch generic versions Fosamax this week.
Teva press release-1
Teva Pharma announced today that the USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's osteoporosis treatment Fosamax(R) (Alendronate Sodium) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. Shipment of the product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva press release-2
Teva Pharmaceuticals is pleased to announce the introduction and availability of Alendronate Sodium Tablets. This product is AB rated and bioequivalent to Fosamax®* Tablets. Alendronate Sodium Tablets are available in 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg strengths. “Our customers count on Teva for a continuous supply of new generic products,” states John Denman, V.P. Sales and Marketing. “With the launch of Alendronate Sodium Tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”
Barr press release
Barr Pharma today announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax(R) (Alendronate Sodium) Tablets, 70 mg after receiving final approval from the U.S. Food and Drug Administration (FDA). The FDA approved the Company's application on February 06, 2008, 2008, following the expiration of pediatric exclusivity associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favorable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity. "Barr is pleased to be able to provide people suffering from osteoporosis and Paget's disease with a more affordable generic alternative," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "This is particularly critical as our elderly population increases and seeks to maintain their quality of life in their advanced years." Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women. Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.
Merck’s blockbuster osteoporosis drug Fosamax will lose patent protection tomorrow with the expiration of Orange Book listed US4621077 (which covers method of use for approved indication), losing significant $ 1.6 billion US market to generic competition. Earlier in January, Merck announced to sign a deal for an authorized generic but did not disclose the name of its partner. Finally, it is Watson Laboratories that will be selling the authorized version of Fosamax. Barr Pharmaceuticals and Teva Pharmaceutical Industries are also expected to launch generic versions Fosamax this week.
Teva press release-1
Teva Pharma announced today that the USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's osteoporosis treatment Fosamax(R) (Alendronate Sodium) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. Shipment of the product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva press release-2
Teva Pharmaceuticals is pleased to announce the introduction and availability of Alendronate Sodium Tablets. This product is AB rated and bioequivalent to Fosamax®* Tablets. Alendronate Sodium Tablets are available in 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg strengths. “Our customers count on Teva for a continuous supply of new generic products,” states John Denman, V.P. Sales and Marketing. “With the launch of Alendronate Sodium Tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”
Barr press release
Barr Pharma today announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax(R) (Alendronate Sodium) Tablets, 70 mg after receiving final approval from the U.S. Food and Drug Administration (FDA). The FDA approved the Company's application on February 06, 2008, 2008, following the expiration of pediatric exclusivity associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favorable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity. "Barr is pleased to be able to provide people suffering from osteoporosis and Paget's disease with a more affordable generic alternative," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "This is particularly critical as our elderly population increases and seeks to maintain their quality of life in their advanced years." Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women. Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.
