Following is a list of 10 FDA-approved drugs for patients with multiple sclerosis—nine of 10 disease-modifying agents authorized by the agency, plus a drug whose indication is specific to MS patients—ranked by their 2013 sales, as reported by the companies that market them. Drugs are listed by name, sponsor(s), dosage information, mechanism of action, indication, and sales data.
Last year’s best-selling MS drug, Copaxone, will have the challenge in 2014 of sustaining its U.S. sales in the face of competition from several generic versions of glatiramer. Awaiting FDA approval at deadline to sell generic glatiramer once the first patents expire in May are Novartis and partner Momenta Pharmaceuticals, as well as Natco Pharma and partner Mylan. Both teams have prevailed against Teva in patent litigation.
Last month Teva highlighted a study it commissioned and funded, showing differences in gene expression linked to key therapeutic effects between Copaxone and Natco’s glatiramer. Teva insists it acted more from patient safety that from a desire to protect a lucrative drug franchise that has accounted for 20% of total sales and about half of total earnings. Teva also hopes to beat back the generic challengers with a new dosage that won FDA approval last month. The new dosage allows patients to take 40 mg three times weekly, rather than the current regimen of 20 mg daily. The company has said it plans to convert 57% of current Copaxone patients to the new dosage.
As well as Copaxone has performed for Teva, Biogen Idec generated more in sales from MS drugs last year, with three of its own products and a fourth product partnered (with Acorda Therapeutics) in the top 10, accounting for a combined $5.563 billion in sales. Next most prominent on the list is Novartis, with two drugs combining for just over $2 billion, followed by three pharma giants and two biotechs, each with $1 billion or less in sales.