The USFDA has approved the generic versions of Depakote delayed-release tablets (Divalproex sodium) after the following orange book listed patents expired on 29th July,2008.
US4988731: which covers diethyl- or dipropylacetic acid salts of sodium valproate which have physiological properties similar to those of valproic acid or sodium valproate but show highly superior stability characteristics.
US5212326: Which covers Sodium hydrogen divalproate oligomer
The following generic players have received approval to market divalproex sodium delayed-release tablets:
1) Sun Pharma
2) Genpharm
3) Nu-Pharm
4) Upsher-Smith Lab
5) Sandoz
6) TEVA Pharma
7) Dr. Reddy’s Lab
8) Lupin
These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (Valproic acid activity) tablets are bio-equivalent to Depakote ® delayed release tablets distributed by Abbott Laboratories.
Earlier news from IPPharmadoc on this product Here , Here, Here, Here and Here
Friday, 1 August 2008
Divalproex Sodium (Depakote delayed-release tablets): USFDA Approved generic version after the patent expiry
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