The USFDA has approved/tetatively approved ANDA’s filed by following generic players for generic launch of Topiramate (Topamax) 25, 50, 100, 200 mg tablets:
1. ROXANE
2. PAR PHARM
3. MYLAN
4. BARR
5. TEVA (link to Fox news Here on Teva's generic launch)
6. RANBAXY
7. CIPLA LTD
8. GLENMARK GENERICS
9. COBALT LABS INC
10. APOTEX
11. PLIVA HRVATSKA DOO
12. ZYDUS PHARMS (Pharmalive news Link on generic launch)
13. AUROBINDO PHARMA
14. TORRENT PHARMS
15. UNICHEM
16. LUPIN
17. Sun Pharma (press releaseon generic launch Here)
The approved generic forms are AB rated w.r.t innovator’s tablets. The final approval to some generic players who are first para IV filer like Mylan and Cobalt was given after the expiry of product patent covering Topiramate.
Earlier, generic companies like Mylan and cobalt were trying to erode the generic market much before the expiry of product patent US4513006, however, the final decision in litigation was in favor of innovator Ortho-McNeil and court (CAFC) concluded that ‘006 patent is valid and enforceable, accordingly, generic launch was delayed as reported earlier by IPPharmdoc Here. Also, the said patent was scheduled to expire in September, 2008, however, innovator got paediatric exclusivity for six months on this patent (as reported by IPPharmadoc Here) and generic launch was delayed till March 27, 2009.
Topiramate (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. Generic versions are available in Canada and were FDA approved in September 2006 .
Topiramate was discovered in 1979 by Drs. Bruce E. Maryanoff and Joseph F. Gardocki during their research work in McNeil Pharmaceutical.This drug is used to treat epilepsy in both children and adults. As per Wolters Kluwer Health (formerly NDC Health), Topiramate had sales over $3.2 billion for the 12 months ending February 28, 2009.
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