The generic players have entered into the US market after the expiry of innovator GSK’ patent US4602017 (Expiry: Jan 22, 2009): which covers Lamotrigin as product.
Following generic players have got tentative or final approval for this product:
1. Cadista- Approved on January 27, 2009 for ANDA No. 079132
2. Teva- Approval on August 30, 2006 for ANDA No. 076388
3. Dr. Reddy- Approval on January 27, 2009 for ANDA No. 076708
4. Roxane- Approved on January 27, 2009 for ANDA No. 077392
5. Mylan- Approved on January 27, 2009 for ANDA No. 077420
6. Genpharm- Approved on June 21, 2006 for ANDA No. 077428
7. Zydus Pharm- Approved on January 27, 2009 for ANDA No. 077633
8. Caraco- Approved on November 9, 2007 for ANDA No. 077757
9. Watson- Approved on November 9, 2007 for ANDA No. 077783
10. Matrix- Approved on November 9, 2007 for ANDA No. 078443
11. Taro- Approved on January 27, 2009 for ANDA No. 078525
12. Apotex- Approved on January 27, 2009 for ANDA No. 078625
13. Sandoz- Approved on January 27, 2009 for ANDA No. 078645
14. Torrent- Approved on January 27, 2009 for ANDA No. 078947
15. Aurbindo- Approved on January 27, 2009 for ANDA No. 078956
Note: Caraco, Watson and Matrix has got tentative approval
Lamotrigin is indicated for treatment of convulsions. Lamotrigine was first approved by the USFDA in 1994, for the treatment of partial seizures, and in 2003 for long-term management of bipolar disorder
No comments:
Post a Comment