Mylan’s generic Xibrom ophthalmic solution enters market
PITTSBURGH — Mylan has launched a generic drug for treating post-operative inflammation in patients who have undergone cataract extraction, the company said Monday.
Mylan announced the launch of bromfenac ophthalmic solution in the 0.09% strength, for twice-daily administration, under a development and supply agreement with Coastal Pharmaceuticals.
The drug is a generic version of ISTA’s Xibrom ophthalmic solution. Various versions of bromfenac ophthalmic solution had sales of about $116 million during the 12-month period ended in March, according to IMS Health.
Teva to acquire Taiyo
JERUSALEM — Generic drug maker Teva Pharmaceutical Industries will acquire a privately owned manufacturer of generic drugs based in Japan, Teva said Monday.
Teva announced the purchase of a 57% stake in Nagoya, Japan-based Taiyo Pharmaceutical Industry Co. for $460 million, with plans to extend its offer to purchase all remaining shares of the company.
Taiyo is Japan’s third-largest generic drug company, with sales of $530 million in 2010 and a product portfolio of more than 550 generic drugs, including injectables used in hospitals. Teva president and CEO Shlomo Yanai said the acquisition would position Teva as a leading player in Japan’s quickly growing generics market.
Generic, authorized generic of Amrix launched
PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.
Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.
As the first company to file for Food and Drug Administration approval of a generic version of Amrix, Mylan will have 180 days of market exclusivity in which to compete directly with the branded version, under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.
In related news, Watson subsidiary Watson Pharma has launched an authorized generic of Amrix in the 15-mg and 30-mg strengths, as part of an agreement with Anesta AG, a subsidiary of Cephalon. Under the terms of the nonexclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of the authorized generic product.