Wockhardt has become one of the first generic producers of Nizatidine capsules for the Europe market. Ivax Pharmaceuticals of the UK, a subsidiary of Ivax Corporation of the US launched Nizatidine capsules, manufactured by Wockhardt, in UK yesterday.
The launch follows the expiry of the UK product patent on Nizatidine on July 29, 2002. Nizatidine is the generic name of Axid marketed by Eli Lilly. Nizatidine 150mg and 300 mg capsules are being manufactured exclusively for Ivax by Wockhardt, at its Aurangabad plant.
Habil Khorakiwala, chairman of Wockhardt said, "Our challenge was to develop a unique process to produce Nizatidine bulk drug without violating the complex European process patents. It is a matter of pride that ours is one of the first products in the UK market, apart from that of the innovator."
It took about a year for Wockhardt to develop, scale up and perfect the technology. The product was jointly developed in a collaborative venture with IVAX. Because of the high quality of documentation submitted jointly by IVAX and Wockhardt, the MCA (Medicines Control Agency), UK, approved the product in a relatively short period of less than a year. Wockhardt has two manufacturing facilities approved by MCA.
Global sales of Nizatidine, used in the treatment of heartburn, acidity, indigestion and sour stomach, were approximately $350 million in 2001, of which the US accounted for $233 million. Wockhardt has also filed a drug master file (DMF) in the US and is in the process of becoming a supplier to the US too.