Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics Ltd, today announced that it has been granted final approval by the United States Food and Drug Administration (USFDA) for Norethindrone tablets 0.35mg, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals Inc.
Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy. Total sales of this niche generic contraceptive product were $43 million for the 12 month period ending March 2010, according to IMS Health.
This is the Glenmark's third female hormonal product approval and it is the second approval for an oral contraceptive.
The company received approval in April 2010 for Heather tablets, their generic version of Watson's Nor-QD tablets and the company received approval for Norethindrone Acetate 5mg tablets yesterday.
Glenmark remains the only Indian company to be granted an ANDA approval for a female hormonal product and an oral contraceptive product. The US contraceptive market has historically been the largest of the seven major markets with sales reaching $4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health).
Glenmark already has existing abbreviated new drug applications (ANDAs) pending approval with the USFDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.
About Glenmark Generics limited: Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.
It primarily sells its FDF products in the US and the EU, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.