Race you for US$1.8 billion

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Race you for US$1.8 billion

Generics/News | Posted 11/03/2011 0 Post your comment

The market for proton pump inhibitor pantoprazole in the US is estimated to be worth Euros 1.3 billion a year, and drug companies are scrambling to sell generic versions now that Pfizer’s patent has expired.

Teva Pharmaceutical Industries first launched a generic version in the US on 22 December 2007. Then Sun Pharma launched the same on 30 January 2008, after receiving FDA approval. The originator company Wyeth sued the two for patent infringement and launched its own generic version with Nycomed. It is speculated that Sun had to pay US$300 million (Euros 220 million) and Teva US$1 billion (Euros 730 million) for jumping the gun, and that Teva has reviewed its policy of launching generics before they are off-patent.

On 19 January 2011 the patent finally expired and four Indian companies were under starter’s orders. Dr Reddy's Laboratories, Torrent Pharmaceuticals, Mylan Laboratories and Wockhardt have all received final approval from the FDA to market 20 mg and 40 mg pantoprazole delayed release tablets. They have the specialised technology and manufacturing capability required.

“This is yet another product that Wockhardt has been able to launch on the date of the patent expiry”, Wockhardt Chairman Mr Habil Khorakiwala enthused. “The ability to launch products on the date of patent expiry is a critical requirement to create maximum value over the years and Wockhardt has been able to reinforce this capacity on several occasions”.

The company will manufacture the generic tablets at its FDA-certified plant at Waluj, Maharashtra, India. The active pharmaceutical ingredient is made at its plant at Ankleshwar in Gujarat, India.

Mylan’s subsidiary Matrix Laboratories ‘will ship the product immediately’.

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Sun and Teva losing battle over generic Protonix

Source: Business Times, Economic Times, Mylan, Wockhardt