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Mumbai, March 31 Sun Pharmaceutical Industries Ltd has launched its generic version of Amifostine Injection 500 mg in the US.

Generic Amifostine is therapeutically equivalent to Medlmmune’s Ethyol, a medicine used as an adjunct to cancer therapy, protecting against the side-effects of chemotherapy and radiation treatment. The US launch comes even as Sun Pharma remains locked in a patent-infringement suit with MedImmune, for over three years now.

Ethyol is covered under three patents — ’471 up to July 31, 2012, ’731 up to July 31, 2012, and ’409 till December 08, 2017, a note from Sun Pharma said. This abbreviated new drug application (ANDA) was filed with para IV certification (involving a patent challenge) against all the patents MedImmune filed, and the case is still under litigation in a US Court, the company said.

Sun Pharma’s product is being sold in the US by its marketing partner Caraco Pharmaceutical Laboratories. The company had received a regulatory US Food and Drug Administration approval for this in March.

Ethyol has annual sales of approximately $80 million in the US. The company being the first-to-file an ANDA for generic Ethyol with a para IV certification, it has a 180-day marketing exclusivity when it markets the drug in the US.

No other generic drug company will be able to launch its version of generic Amifostine for six months from the date that Sun Pharma had launched its version of the same drug in the US, a pharma analyst said.

Indian drug companies have adopted the para IV route, a parameter in the US law, to enter the market. The method involves a patent infringement, where the challenging generic company would get a “jackpot” if it wins the case filed by the innovator whose patent has been infringed. However, if the local company loses the case to the innovator, it would be liable to pay the damages, the analyst said.

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