Teva delays introduction of generic copaxone while promoting new formulation
- Teva has attempted to delay introduction of generic copaxone (glatiramer acetate injection) by asking the Supreme Court to hear a patent-related appeal. The company also attempted to sue FDA to block approval of generic copaxone, used for the treatment of multiple sclerosis.
- Generic manufacturers fought back claiming that such actions would hurt them significantly.
- If Teva prevails, the company could retain exclusivity until September 2015. Meanwhile, Teva’s new formulation of copaxone, which was approved in January 2014, has performed well with patients, who are loyal to the brand.
On May 8th, Pharmaceutical Executive magazine named Copaxone the brand of the year. Since its introduction in 1997, the brand strategy for Copaxone, which grossed approximately $4.2 billion last year, has paid off. However, the introduction of generic copaxone will be very costly to Teva. The question is: how costly? Generics manufacturers, including Sandoz, Momenta Pharmaceuticals, Mylan and Natco Pharma, are poised to enter the market at the beginning of the summer. Teva hopes to maintain exclusivity beyond patent expiry (this month) for as long as possible by challenging generics manufacturers in court, citing insufficient clinical testing of the new formulations.
In January 2014, FDA approved Teva’s new formulation of Copaxone — a three-times weekly formulation versus a once-daily 20 mg/mL injection. Insurers want lower-cost treatment options for patients, and generics manufacturers are prepared to offer lower-priced products. Nonetheless, Teva continues to cite quality concerns about generic equivalents and to entice customers with a support program.
- Teva Teva Announces U.S. FDA Approval of Three-Times-a-Week COPAXONE® (glatiramer acetate injection) 40mg/mL
- FierecePharma Desperate to ward off Copaxone copies, Teva sues FDA Read more: Desperate to ward off Copaxone copies, Teva sues FDA - FiercePharma http://www.fiercepharma.com/story/desperate-ward-copaxone-copies-teva-sues-fda/2014-05-12#ixzz32DPp5R8L Subscribe at FiercePharma
- AIS Health New Copaxone Formulation Could Help Teva Retain Market Share
- Marketwatch.com (WSJ) Teva Announces COPAXONE® Recognized as “Brand of the Year” by Pharmaceutical Executive Magazine