Possible 2012 Product Launches

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
This entry was posted in Industry Updates, Manufacturers Updates. Bookmark the permalink.

Comments are closed.