Glenmark Pharma inches up after confirming patent fight for a generic in US

The announcement was made after market hours on Friday, 12 July 2013.

Meanwhile, the S&P BSE Sensex was down 28.05 points or 0.14% at 19,930.42.

On BSE, 11,000 shares were traded in the counter as against average daily volume of 63,150 shares in the past one quarter.

The stock hit a high of Rs 610.10 and a low of Rs 596.05 so far during the day. The stock had hit a 52-week high of Rs 612 on Friday, 12 July 2013. The stock had hit a 52-week low of Rs 361 on 26 July 2012.

The stock had underperformed the market over the past one month till 12 July 2013, gaining 2.72% as compared to the Sensex's 4.82% rise. The stock had, however, outperformed the market in the past one quarter, jumping 22.77% as compared to the Sensex's 9.41% surge.

The large-cap company has equity capital of Rs 27.09 crore. Face value per share is Re 1.

Glenmark Generics (GGL) has filed abbreviated new drug applications (ANDAs) for Lacosamide Tablets, and Oral solution with the United States Food and Drug Administration (USFDA) with a Paragraph IV Certification for the Orange-Book listed patent. Glenmark's ANDA products are generic versions of VIMPAT, which are indicated for an adjunctive therapy in the treatment for partial-onset seizures in adults with epilepsy.

According to IMS Health data, the VIMPAT tablets and solution had annual sales of approximately $353 million in the United States for the twelve months ended 31 March 2013.

On 10 July 2013, UCB, INC., UCS Pharma GmbH, Research Corporation Technologies, Inc. and Harris FRC Corporation filed suit against Glenmark Generics and Glenmark Generics Inc., in the United States District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of US Patent. This lawsuit was filed under the provisions of the Hatch-Waxman Act. If Glenmark is successful in its challenge of the patent, it will garner 180-day exclusivity for its products.

GGL is a subsidiary of Glenmark Pharmaceuticals. It has an established presence in North America and developing an European Union (EU) presence. It primarily sells 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 80 countries, including the US, various countries in the EU, South America and India.

Glenmark Pharmaceuticals' consolidated net profit rose 10.9% to Rs 166.80 crore on 25.3% growth in net sales to Rs 1335.49 crore in Q4 March 2013 over Q4 March 2012.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). The company along with its subsidiary has 13 manufacturing facilities in four countries and has five R&D centres.

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