Glenmark to market asthma medicine theophylline generic in US

Indian generic maker Glenmark will launch asthma medication theophylline pills in the US market.

Glenmark’s theophylline extended-release tablets have been granted marketing approval bythe United States Food and Drug Administration (US FDA).

Theophylline extended release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g. emphysema and chronic bronchitis.

Glenmark will launch theophylline extended-release tablets in strengths of 400 mg and 600 mg.

The company will commence marketing and distribution of this product immediately in the US and anticipates a successful launch based on limited competition existing in this niche segment.

Glenmark’s theophylline extended-release tablets are the generic version of Purdue Pharmaceutical Products’ LP Uniphyl.

According to IMS health, Theophylline extended-release tablets had annual sales of USD 8 million.

Glenmark Generics Inc. (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced that they have been granted ANDA approval from the United States Food and Drug Administration(US FDA) for Theophylline extended-release tablets, the generic version of Purdue Pharmaceutical Products, LP Uniphyl.

After this approval, the company’s current portfolio consists of 56 generic products authorized for distribution in the US market, as well as over 50 ANDAs are filed with the US FDA for approval.

In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Glenmark is also planning to launch its adapalene gel treatment for a severe form of acne in US.

Adapalene gel is indicated for the topical treatment of acne vulgaris.

Acne vulgaris is the common form of acne seen most often in teenagers or young adults. Acne vulgaris is the result of overactive oil glands that become plugged, red, and inflamed.

Glenmark’s adapalene gel product is the AB rated generic equivalent of Galderma’s Differin gel which generated approximately USD 84 million in sales for the 12 month period ending March 2010, according to IMS Health.

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.

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.