Glenmark to launch norethindrone (Aygestin) generic pill to treat lack of menstrual flow in US

India’s Glenmark Pharmaceuticals will soon launch generic version of Aygestin to treat absence of menstrual flow in US.

Glenmark has received US FDA approval to market and distribute generic norethindrone acetate, in the US, the company said in a press release.

Norethindrone acetate is the generic version of Duramed Research Inc’s Aygestin and is also indicated for the treatment of secondary amenorrhea, endometriosis and abnormal uterine bleeding due to hormonal imbalance, it added.

The approval for norethindrone acetate tablets in 5 mg strength, is granted by the US Food and Drugs Administration (USFDA) to Glenmark Generics Inc, a subsidiary of group firm Glenmark Generics, Glenmark Pharmaceuticals said in a statement.

The company will commence marketing and distribution of the product immediately, it added.

Norethindrone Acetate is the generic version of Duramed Research Inc’s ‘Aygestin’ and is also indicated for the treatment of secondary amenorrhea, endometriosis and abnormal uterine bleeding due to hormonal imbalance, it added.

“Today’s approval marks the second product approval by the USFDA from Glenmark’s hormone facility located in Goa,” the company said. Related:Glenmark to launch adapalene gel to treat a severe form of acne in US

According to IMS health, norethindrone acetate tablets garnered approximately $27 million in sales for the 12 month period ending March 2010. The US contraceptive market recorded sales of $4.5 billion in the 12 months ended December 2009.

The company’s current portfolio consists 57 products authorised for distribution in the US market. It has over 50 Abbreviated New Drug Applications pending approval with the US health regulator.

In April, Glenmark was granted approval for generic contraceptive pill norethindrone tablets 0.35mg by the United States Food and Drug Administration (US FDA).

Glenmark’s norethindrone tablets 0.35mg is the generic version of Nor-QD.Related:Glenmark to market asthma medicine theophylline generic in US

Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy.

Glenmark will be market norethindrone pills under the trade name Heather and distribution is expected to start immediately, the company said in a press release.

The US contraceptive market has sales reaching USD 4.5 billion in the 12 month period ending December 2009, according to MIDAS sales data, IMS Health.

Total sales of this niche generic contraceptive product were USD 38 million for the 12 month period ending December 2009, according to IMS Health.