Two Indian drugs majors have launched generic versions of a drug used in controlling nausea and vomiting in cancer patients, following the expiry of Glaxo SmithKline''s product patent on the successful product in the American market.
Wockhardt USA Inc, the US subsidiary of India''s leading pharmaceutical company, launched Ondansetron injection in the US market on December 26, the first working day after the patent for the product expired on December 24.
Ondansetron is the generic version of Glaxo SmithKline''s Zofran injection and is used in controlling nausea and vomiting following cancer chemotherapy.
"This is Wockhardt's eighth product approval from US FDA in 2006 and the third injection product in the US market," said Wockhardt chairman Habil Khorakiwala. "We now market 15 products in the US, 10 of them launched during 2006."
Ondansetron is the largest selling anti-emetic product in the world. Sales of Zofran injection in the US during the 12 months ending September 30, 2006, were $628 million. The injection is manufactured at the US FDA-certified sterile formulation plant at Waluj in Aurangabad, India. Wockhardt has two other sterile formulation plants approved by the FDA in India and the UK.
Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile APIs (active pharmaceutical ingredients), the dosage forms and marketing them through a wholly-owned subsidiary in the US, enabling the company to capture maximum value.
The pharmaceutical and biotechnology giant has an active multi-disciplinary research programme employing 400 scientists. Its new drug discovery programme has yielded several promising molecules, one of which is now in Phase II human clinical trials. The US and European Union contribute to more than half of Wockhardt's sales.
Hyderabad-based major Dr Reddy''s Laboratories (DRL)also announced that it has received FDA approval to market Ondansetron Hydrochloride tablets - in multiple strengths - in the US.
The company, which has been granted a 180-day period of marketing exclusivity, plans to ship the products shortly. "We are obviously pleased with the final approval of our generic version of Zofran with 180-days of marketing exclusivity," said G V Prasad, vice-chairman and CEO, DRL. "With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the US in the medium term."
The approval follows a US court of appeals order denying Apotex's request that the FDA should not approve DRL's generic products.