Innovator Ortho-McNeil Neurologics announced today that the USFDA has granted pediatric exclusivity for TOPAMAX(R) (Topiramate). The new expiries for Orange Book listed patents is as follows:
US4513006 (Expiry: Mar 26, 2009)
US5998380 (Expiry: Apr 13, 2016)
US6503884 (Expiry: Apr 13, 2016)
US7018983 (Expiry: Apr 13, 2016)
Earlier, U.S court has upheld innovator’s product patent ‘006 on appeal by MylanTopiramate (2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson.
US4513006 (Expiry: Mar 26, 2009)
US5998380 (Expiry: Apr 13, 2016)
US6503884 (Expiry: Apr 13, 2016)
US7018983 (Expiry: Apr 13, 2016)
Earlier, U.S court has upheld innovator’s product patent ‘006 on appeal by MylanTopiramate (2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson.
The Generic launch will be delayed till Mar 26, 2009
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