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Friday, October 23, 2015 9:35:49 AM
-Protonix® accepted by the FDA on Oct 18th, 2010
-No Protonix/Wyeth patent infringement lawsuit filed by Wyeth
-Wyeth completed the FDA's new labeling requirements on Protonix in December 2014 suggesting the FDA is now working with the generic co's like IPCI ensuring the ANDA labeling is upgraded
-Protonix currently at the 60 month mark from the "FDA accepted for filing date" awaiting FDA approval
*pantoprazole (Protonix) treats gastro-esophageal reflux disease (GERD). In the western world between 10-20% of the population affected
-Glucophage®XR accepted by the FDA b4 end of October 2010
-Glucophage has/had no patent litigation to contend with
-Glucophage currently at the 60 month mark from the "FDA accepted for filing date" awaiting FDA approval
*metformen (Glucophage XR) is now believed to be the most widely used antidiabetic drug in the world. In the U.S. alone more than 48M perscriptions were filled in 2010
-EffexorXR® accepted by the FDA on May 7th, 2010
-Effexor/Wyeth/Pfizer settlement reached on June 21, 2011
-Wyeth completed the FDA's new labeling requirements on Effexor in December 2014 suggesting the FDA is now working with the generic co's like IPCI ensuring the ANDA labeling is upgraded
-Effexor currently at the 52 month mark from the patent infringement settlement date awaiting FDA approval
*venlafaxine (Effexor XR) In 2007 venlafaxine was the 6th most commonly prescribed antidepressent in the U.S. retail market with 17.2M perscriptions
-Lamictaf®XR accepted by the FDA on October 31st, 2011
-Lamictaf®XR has/had no patent litigation to contend with
-Lamictaf®XR currently at the 48 month mark from the "FDA accepted for filing date" awaiting FDA approval
Anti-convulsant for epilepsy with 4 strengths under review by FDA. Because there are no unexpired patents associated with this product IPCI will not be subject to the automatic 30-month stay of FDA approval to market the product and will be in a position to market Lamictaf®XR in the United States immediately upon FDA approval. According to Source Healthcare Analytics, sales of Lamictal®XR™ in the United States were approximately $279 million (TRx MBS Dollars) for the 12 months ended February 2013
Recent IPCI News
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