Financial Daily from THE HINDU group of publications
Tuesday, Dec 03, 2002
Financial Daily from THE HINDU group of publications Tuesday, Dec 03, 2002 |
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Corporate
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Outlook Morepen to gain from loratidine's OTC status P.T. Jyothi Datta
NEW DELHI, Dec. 2 IT certainly seems to be a case of one company's meat being another's poison in the pharma industry, with allergy drug Loratidine being accorded the status of an over-the-counter (OTC) drug. According to pharma industry analysts, this recent shift of Loratidine from being an ethical or prescription product to an OTC drug is likely to weaken the six months exclusivity status that Geneva Pharma, the generic arm of Novartis, was to enjoy beyond December 2002. Laying out the implications of the situation, the industry source told Business Line that Geneva Pharma had a Para IV filing for an Abbreviated New Drug Application (ANDA), or it had an innovation on the existing version of Loratidine which won it a six-month exclusivity period from the US regulatory body, the USFDA. Home-grown pharma company, Morepen Laboratories, touted to be the second largest generic manufacturer of Loratidine in the world, was the main supplier to Geneva Pharma. "But with Loratidine becoming an OTC, it would weaken or render null the exclusivity period of Geneva Pharma. And the good news here for the Indian company is that other procurers of Loratidine, who had to stay away from it till the end of the six-month period, no longer need to do that. So more companies can procure Loratidine from generic manufacturers and Morepen being among the largest in the segment, it stands to gain," the source said. The original patent was held by US-based Schering Plough till December 19 this year. Its brand is called Claritin and only last week, the UFDA had accorded it the OTC status. Loratidine sales in the US are put at an estimated $3.2 billion and understandably, the US accounts for 80 per cent of global sales. And even as Morepen has Rs 45 crore worth of Loratidine pending shipment to the US, according to the industry analyst, other Indian companies like Ranbaxy and Alembic also may be able to "partake of this Loratidine pie".
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