First-time generics get US boost

Indian pharmaceutical companies led by Ranbaxy Laboratories have bagged 20 first-time generic approvals from the US Food and Drug Administration (FDA) in the eleven months from January to November this year, which constitutes about a quarter of the total 81 approvals given in this period.

This is the highest ever first-time generic approvals for Indian companies in a year, according to industry observers.

In the first corresponding period last year, Indian generic companies got just 11 first-time generic approvals (about 12.5 per cent) of a total 88 given during the 11 month period. 
 

BIG DOSE
Generic drug name	Generic manufacturer	Brand   (Company)
Valacyclovir	Ranbaxy	Valtrex (GSK)
Sertaline hydrochloride	Ranbaxy	Zoloft (Pfizer)
Didanosine oral solution	Aurobindo	Videx  (Bristol Myers Squibb)
Cefixime oral suspension	Lupin	Suprax
Nimodipine capsules	Sun Pharma	Nimotop  (Bayer)
Zolpidem tartrate	Ranbaxy,Dr Reddy's, Caraco	Ambien  (Sanofi-Aventis)
Pravastatin sodium	Ranbaxy	Pravachol tablets
Benzonatate	Zydus Cadila	Tessalon Perles  capsules
Cefepime injection	Orchid	Maxipime
Carvedilol	Glenmark, Ranbaxy, Caraco, Lupin,  Zydus, Dr.Reddy's	Coreg
Oxcar-bazepine	Glenmark, Sun Pharma	Trileptal
Rivastigmine	Sun Pharma	Exelon capsule
Note: First time generic approvals for Indian companies till Nov 2007

"First-time generic means the approved generic player will have the first mover advantage in terms of price and marketing in the US, which is crucial in the generic business," explained Prof R D Joshi, director-business processes, Interlink Consultancy.

"Competition will be less and this may help the companies grab even upto 90 per cent of the price upon expiry of patents, instead of the heavy price erosion."

According to various estimates, a $77 billion market (about Rs 300,000 crore) in brand-name drugs will open to generic competition in the US between 2006 and 2012.

Ranbaxy leads the Indian table with five approvals, which includes generics of such blockbuster drugs as Valtrex (GSK's genital herpes drug), Pfizer's anti-depressant Zoloft, BMS' cholesterol-lowering drug Pravachol, Coreg (GSK's hyper-tension and cardiac drug brand) and Sanofi-Aventis's insomnia drug Ambien.

The other Indian companies that got first-time generic status are Aurobindo (Videx oral solution), Lupin (cefixime oral suspension), Zydus Cadila (tessalon capsule), Orchid (cefepime injection), Sun Pharma (nimodipine, trileptal and exelon) and Glenmark (trileptal).

Sujay Shetty, associate director at the consultancy firm PricewaterhouseCoopers said that this is proof of India's emergence in the field of generics in the US, in the face of competition and pricing pressures.

"It is estimated that Indian companies account for half of the filings in the US and have about 90 US FDA approved plants. This trend will continue and India will have more approvals," he said.

More Indian players are emerging in the US market, like Glenmark, Lupin, Zydus and Orchid, along with established players like Ranbaxy and Dr Reddy's, Shetty said.

According to provisions of the US Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, when patents or other periods of exclusivity expire for drugs, manufacturers can apply to the FDA to sell generic versions through abbreviated new drug applications (ANDAs).

First to file ANDAs (mostly a para IV certification which challenges the patent), translate into a 180-day exclusivity for companies, on approval.

However, to negate this advantage, innovator companies resort to out-of-court settlements allowing entry of authorised generic versions. Indian companies such as Ranbaxy and Dr Reddy's each claim to have over 20 first to file ANDAs pending approval.