Summary
As a Pharmaceutical consultant and pharmacist I read this article with great interest since prices Topiramate will further reduced due to additional generic company. Topamax® is very useful drug for the treatment of adult and pediatric Epilepsy. On September 2006, Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets, 25mg, 100mg and 200mg On March 28, 2009, Various companies (Teva, Sun, Ranbaxy) will market its version of the Topiramate tablets, the medicine in Topamax, in dosages of 25, 50, 100, and 200 mg. Annual sales of Topamax(R) were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.
Analysis
As a Pharmaceutical consultant and pharmacist I read this article with great interest since prices Topiramate will further reduced due to additional generic company. Topamax® is very useful drug for the treatment of adult and pediatric Epilepsy. Topamax ® (generic name Topiramate) is made by Johnson and Johnson unit Ortho-McNeil indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures.
Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 100 mg, and 200 mg tablets for oral administration. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.
On September 2006, Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets, 25mg, 100mg and 200mg.
The FDA has confirmed that Mylan was the first generic company to file on the 25mg, 100mg and 200mg strengths of Topiramate and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a court decision from which no appeal can be taken.
On March 28, 2009, Various companies (Teva, Sun, Ranbaxy) will market its version of the Topiramate tablets, the medicine in Topamax, in dosages of 25, 50, 100, and 200 mg.
Annual sales of Topamax(R) were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.
