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ipci

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Reply with quote  #1 
Timeline on IPCI's next 4 expected FDA ANDA approvals: 

-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 53 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 53 month mark from the "FDA accepted for filing date" awaiting FDA approval 
*metformen (Glucophage XR) is now believed to be the most widely 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 45 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 

-SeroquelXR® accepted by the FDA on May 3rd, 2011 
-Seroquel/AstraZeneca patent litigation settlement reached on July 31st, 2012 
-Seroquel currently at the 32nd month mark from the patent infringement settlement date awaiting FDA approval 

Rest of the already filed with the FDA for acceptance ANDA's following the timelines on the above 4 ANDA's: 

Lamictaf®XR September 2011 
Keppra XR® June 2012 
Pristiq® September 2012 

Next expected to be filed for acceptance with the FDA ANDA: 

CoregCR® which is listed as still under studies
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