New Delhi: Drug firm Dr Reddy`s Laboratories today said it has launched it`s generic Finasteride tablets used for treating male pattern hair loss in the American market.
The company has launched Finasteride tablets in the strength of 1 mg in the US market on January 2 following the approval of its abbreviated new drug application (ANDA) with 180 days of marketing exclusivity, Dr Reddy`s Laboratories said in a statement.
The tablets are bioequivalent generic version of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co Inc`s Propecia tablets, it added.
"The Propecia tablets brand has US sales of approximately USD 136 million for the most recent twelve months ending in October 2012 according to IMS Health," Dr Reddy`s said.
The generic Finasteride tablets 1 mg of the company is available in bottle counts of 30 and 90, it added.
Shares of Dr Reddy`s Laboratories were today trading at Rs 1,886.80 in the afternoon trade on BSE, up 2.67 per cent from its previous close.
On October 1 2004, Dr. Reddy`s said it had filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration for Finasteride tablets 1 mg with a Paragraph IV certification on three of the four Orange Book patents listed for the drug, in June 2002.
In September 2002, Dr. Reddy`s had notified Merck, upon which the latter did not file a lawsuit within the 45-day period under the Hatch-Waxman Act. However, on September 29, 2004, Merck filed a lawsuit in the United States District Court for the District of Delaware, alleging patent infringement on the `817 and `957 patents, DRL had said.
Later, the Indian drug maker was given 180 days exclusivity right to enter the market in January 2013 and the patent for the blockbuster drug expires in October 2013.
Hyderabad-based generic drug maker Hetero Drugs was given right to market the generic version from July 1, 2013, according to a statement issued by Merck earlier.
"...A patent infringement lawsuit was filed in the United States against Hetero Drugs Limited (Hetero) in respect of Hetero`s application to the FDA seeking pre-patent expiry approval to sell a generic version of Propecia."
"In March 2011, the company settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride product beginning on July 1, 2013," Merck had said in the statement with SEC.
Hetero officials were not available for comment.