| Actos | 17-Aug | $3.5 billion | Mylan – :first to file” Teva – authorized generic |
| Actosplus Met | 14-Dec | $459 million | Mylan – :first to file” Teva – authorized generic |
| Atacand | 4-Dec | $122 million | Tentative approval: Lek, Matrix |
| Atacand HCT | 4-Dec | $59 million | Mylan – “first to file” |
| Avalide | 30-Mar | $330 million | Tentative approval: Mylan, Teva, Sandoz, Roxane, Zydus |
| Avandamet | 17-Mar | $161 million | |
| Avandaryl | 17-Mar | $35 million | |
| Avandia | 17-Mar | $286 million | Teva Pharmaceutical Industries Ltd. announced today that the District Court case has been settled on terms that are confidential allowing Teva by license to enter the U.S. market with its generic versions of Avandia® |
| Avapro | 30-Mar | $398 million | Tentative approval: Teva, Cipla, Sandoz, Zydus, Mylan, Lupin |
| Boniva | 17-Mar | $692 million | Apotex Inc. agreed to delay selling a generic version of the osteoporosis drug Boniva until a judge rules on the validity of a Roche Holding AG (ROG) patent on the medicine that expires in March 2012. Apotex, based in Toronto, is seeking U.S. Food and Drug Administration approval to sell a copy of Boniva. In 2007, Roche sued in federal court in Newark, New Jersey, claiming its patent is valid and enforceable, and that Apotex infringed it. Under an accord filed in court Oct. 11, Apotex agreed it wouldn’t sell its copy until U.S. District Judge Stanley Chesler rules on the validity and enforcement questions or the patent expires, whichever comes first. |
| Clarinex 5mg | 1-Jul | $300 million | Mylan and Orchid |
| Diovan | 21-Sep | $1.5 billion | Ranbaxy believe they are “first to file”; however they have relinquished several exclusivities as part of a settlement with the FDA, this may or may not be one of them. Tentative approval: Teva |
| Diovan HCT | 21-Sep | $1.4 billion | Mylan – “first to file” |
| Gabitril | 24-Mar | $51 million | Tentative approval: Sun Pharma |
| Geodon | 2-Mar | $1 billion | Tentative approval: Lupin, Sandoz, Dr. Reddy |
| Lescol | 11-Apr | $26 million | Mylan believes they are “first to file” |
| Lescol XL | 11-Apr | $67 million | Tentative approval: Par |
| Lexapro | 14-Mar | $2.5 billion | Mylan launching 2 weeks early – 2/29. Teva will launch 3/14 180-day exclusive |
| Maxalt | 29-Dec | $278 million | Tentative approval: Cipla, Mylan, Sandoz, Teva |
| Maxalt MLT | 29-Dec | $232 million | Final approval: Dr. Reddy, Sandoz, Watson.Tentative: Orchid |
| Plavix | 17-May | $5 billion | |
| Provigil | 6-Apr | $1 billion | Mylan and Ranbaxy granted a non- exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States. Mylan believes they are “first to file” |
| Seroquel | 26-Mar | $3.5 billion | Teva lost patent infringement suit, multiple mfg’s expected |
| Singulair | 3-Aug | $3.8 billion | Tentative approval: Endo, Glenmark, Mylan, Roxane, Sandoz, Teva, Torrent |
| Viramune | 22-May | $108 million |
