 "Glenmark to strengthen US presence with more generic filings")
Mumbai-based pharmaceutical major Glenmark Pharmaceuticals is strengthening its position in the world's largest drug market, launching more generic copies. The company, which owns a strong drug molecule pipeline, has been filing a large number of ANDAs (abbreviated new drug applications) of Indian companies with the US Food and Drug Administration (FDA) since FY13.
Glenmark’s US formulations business, with sales of $335 million in FY14, contributes 35 per cent to consolidated revenues. Glenmark was able to launch 58 copycat drugs in the US in the past five years.
However, the company, which wanted to increase its share from the US market, has filed 49 ANDAs from FY13 to the first half of FY15 and four more ANDAs in pipeline for the third quarter of FY15. In total, it is awaiting approval for 72 ANDAs with the FDA. Of these, about 30 ANDAs are paragraph IV ANDAs (which challenge existing drug patents).
A recent report from India Infoline research said, “Increased ANDA filing intensity and focus on differentiated dosage forms should help. Glenmark’s ANDA filing intensity seems to have picked up meaningfully over the past 2.5 years, after hitting the lowest filing rates during FY10-12.” More than 50 per cent of the current filings comprise differentiated products and dosage forms such as oral contraceptives, dermatology products, modified release products, immunosuppressant and oncology injectables, it said.
A mail sent to Glenmark spokesperson did not elicit any response till the time of going to press. On Monday, Glenmark shares went up 2.7 per cent or Rs 20.20 to close at Rs 770.65 on the BSE.
According to a report in June by CRISIL, the top 10 pharma companies in India account for 800 ANDA filings, high as compared with other countries. “The US government’s initiative to provide affordable health care through cost-containment measures and Indian drug maker’s sustained efforts to maintain multiple FDA-approved facilities are the enabling factors behind the rising rate of ANDA approvals,” the report added.
For Glenmark, two launches are expected in the third quarter of FY15, generic Prilosec ($520 mn market size) and that for the hypertension drug, Tarka. Glenmark had lost its patent appeal for Tarka and has asked to pay $25 million as compensation to Abbott. Tarka patent will expire in February. At present, Glenmark's ANDA pipeline includes eight dermatology and 13 oral contraceptive products. Once these are approved, the basket (22 dermatology and 11 OC products in US) will be expanded well.
As far as the paragraph IVs are concerned, Glenmark is the first-to-file (FTF) for the generic version of Zetia. Glenmark, which joined hands with Par Pharmaceuticals for Zetia’s US marketing, is likely to gain about $54 million, during the exclusivity period, said India Infoline report. A cholestrol medicine Zetia has annual sales of $1.45 billion.
Glenmark’s US formulations business, with sales of $335 million in FY14, contributes 35 per cent to consolidated revenues. Glenmark was able to launch 58 copycat drugs in the US in the past five years.
However, the company, which wanted to increase its share from the US market, has filed 49 ANDAs from FY13 to the first half of FY15 and four more ANDAs in pipeline for the third quarter of FY15. In total, it is awaiting approval for 72 ANDAs with the FDA. Of these, about 30 ANDAs are paragraph IV ANDAs (which challenge existing drug patents).
A recent report from India Infoline research said, “Increased ANDA filing intensity and focus on differentiated dosage forms should help. Glenmark’s ANDA filing intensity seems to have picked up meaningfully over the past 2.5 years, after hitting the lowest filing rates during FY10-12.” More than 50 per cent of the current filings comprise differentiated products and dosage forms such as oral contraceptives, dermatology products, modified release products, immunosuppressant and oncology injectables, it said.
A mail sent to Glenmark spokesperson did not elicit any response till the time of going to press. On Monday, Glenmark shares went up 2.7 per cent or Rs 20.20 to close at Rs 770.65 on the BSE.
According to a report in June by CRISIL, the top 10 pharma companies in India account for 800 ANDA filings, high as compared with other countries. “The US government’s initiative to provide affordable health care through cost-containment measures and Indian drug maker’s sustained efforts to maintain multiple FDA-approved facilities are the enabling factors behind the rising rate of ANDA approvals,” the report added.
For Glenmark, two launches are expected in the third quarter of FY15, generic Prilosec ($520 mn market size) and that for the hypertension drug, Tarka. Glenmark had lost its patent appeal for Tarka and has asked to pay $25 million as compensation to Abbott. Tarka patent will expire in February. At present, Glenmark's ANDA pipeline includes eight dermatology and 13 oral contraceptive products. Once these are approved, the basket (22 dermatology and 11 OC products in US) will be expanded well.
As far as the paragraph IVs are concerned, Glenmark is the first-to-file (FTF) for the generic version of Zetia. Glenmark, which joined hands with Par Pharmaceuticals for Zetia’s US marketing, is likely to gain about $54 million, during the exclusivity period, said India Infoline report. A cholestrol medicine Zetia has annual sales of $1.45 billion.