Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Dec 22 2010

Intellipharmaceutics International Inc., today announced that it has notified the U.S. Food and Drug Administration (FDA) that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, Inc., a wholly-owned subsidiary of Pfizer, Inc., for its application to market a generic of Wyeth's Protonix^® (delayed-release pantoprazole sodium) tablets. As part of its abbreviated new drug application (ANDA) filing for generic Protonix^®, Intellipharmaceutics had informed Wyeth that it had submitted paragraph IV certifications of invalidity and non-infringement for the patents that cover Protonix^®. As far as the Company can determine, Wyeth has not filed a patent infringement action within the 45 day period prescribed by Hatch-Waxman Act. 

As a result, Intellipharmaceutics will not be subject to the automatic 30-month stay of FDA approval to market the product as is prescribed by the Hatch-Waxman Act when such patent infringement proceedings have been commenced, and that it will be in a position to market its product in the United States upon FDA approval. No assurance can be given as to whether or when the FDA will approve the Company's application.

"This is a very positive development regarding our generic version of Protonix, as it removes a key legal hurdle in getting our product into the market," stated Dr. Isa Odidi, CEO of Intellipharmaceutics. "We have had a very productive year and look forward to 2011 and adding to the ANDA products we now have before the FDA, which include generics of Focalin XR^®, Effexor XR^®, and Protonix^®."

In October 2010, Intellipharmaceutics announced that the FDA had accepted for filing its ANDA for a generic version of Protonix®, a drug that inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Sales of Protonix^® in the United States were approximately $1.8 billion in 2009.