Wockhardt launches generic version of Protonix tablets in US
Wockhardt has received final approval from the US FDA for marketing 20mg and 40 mg pantoprazole delayed release tablets of pantoprazole (Protonix) that is used for treatment of GI ulcers and hyperacidity. Pantoprazole is the generic name for the brand Protonix marketed in the US by Pfizer. As the patent covering this product expired on January 19, 2011. Wockhardt launched the product immediately.
According to Wolters Kluwer, the total market for this product in the US is about $2 billion and belongs to the class of proton pump inhibitors. The product is a delayed release tablet and requires specialized technology and manufacturing capability.
Habil Khorakiwala, chairman, said, “This is yet another product that Wockhardt has been able to launch on the date of patent expiry. The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years. Wockhardt has been able to reinforce this capability on several occasions.”
The tablet will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and the Pantoprazole sodium API will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat. The tablets and the API were developed in-house.
According to Wolters Kluwer, the total market for this product in the US is about $2 billion and belongs to the class of proton pump inhibitors. The product is a delayed release tablet and requires specialized technology and manufacturing capability.
Habil Khorakiwala, chairman, said, “This is yet another product that Wockhardt has been able to launch on the date of patent expiry. The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years. Wockhardt has been able to reinforce this capability on several occasions.”
The tablet will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and the Pantoprazole sodium API will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat. The tablets and the API were developed in-house.
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