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New pharma players make their mark in US

Mumbai, Oct. 20: A new group of domestic pharmaceutical companies are making inroads into the US generics market, giving a tough competition to established players such as Sun Pharma, Lupin, Ranbaxy and Dr. Reddy’s.

Companies such as Intas Pharmaceuticals, Macleods Pharma, Hetero Labs and Indoco Remedies are focussing on research and looking to tap opportunities in the highly regulated and competitive American market.

“Given that the US is the world’s largest market for generics, we expect competition to intensify further, as the third wave of Indian generic companies start to make a meaningful impact in the country,” Alok Dalal and Hardick Bora of Motilal Oswal Financial Services said in a report.

“Intas Pharmaceuticals is already a strong player in the US. We expect companies such as Indoco Remedies, Unichem Labs and privately held firms such as Macleods, Hetero Labs, Emcure Pharma, Alkem and Micro Labs to increasingly focus on US generics.”

“Given that near-term growth in India is likely to be subdued on account of the recently implemented drug pricing policy, these companies might feel the urge to enter the US even more,” they said.

Intas Pharma’s wholly owned subsidiary — Accord Healthcare Inc — has more than 36 abbreviated new drug applications (ANDAs) approvals in various therapeutic categories and is awaiting permission for more than 30 ANDAs in the US. Accord has also filed para IV ANDA, claiming first to file (FTF) status.

The company, which is set to come out with an initial public offering (IPO), is now expanding its R&D wing by setting up a new facility to capture more high-value first-to-market opportunities in key markets.

ANDA is an application to manufacture, or market, a generic version of a drug. A para IV filing, which is lucrative but risky, is made when the applicant believes its product does not infringe on the innovator’s patents. Such applications could result in a marketing exclusivity period of six months for the generic drug if it comes in the first-to-file category.

Macleods Pharma is awaiting approval for 60 ANDAs. Its US foray is led by a subsidiary that makes generic active pharmaceutical ingredients and finished dosage forms.

Poised for leap

A senior official from a listed pharmaceutical company told The Telegraph that several of these companies were set to emerge as serious players in the US and Europe. In the coming years, these firms will venture into complex products even as they continue to concentrate on FTF opportunities to maximise returns.

Dalal and Bora said that Indian companies were yet to fully exploit the potential as they held less than 10 per cent of the US generics market (in value terms).

OPENING UP THE GENERICS MARKET

Intas Pharma

  • Has more than 36 generic approvals in US; more than 30 proposals awaiting approval
  • Revenue: Rs 3,563 crore

Unichem Labs

  • Has made 29 generic applications in US, 15 have been approved
  • Revenue: Rs 1,005 crore

Indoco Remedies

  • Has 4 products in US and 37 applications at various stages
  • Revenue: Rs 630 crore
 
 
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