Generics Approved for Copaxone
October 4, 2017 – The U.S. FDA has approved a generic, manufactured by Mylan, for Teva’s Copaxone® (glatiramer acetate injection) 40mg/mL formulation. The FDA has also approved Mylan’s generic for the 20mg/mL formulation of Copaxone.
Glatiramer acetate is indicated for the treatment of relapsing multiple sclerosis (RMS), and can be administered at home through a subcutaneous injection by a patient or caregiver. Recommended dosing at 40mg/mL is three times per week. For patients taking the 20mg/mL formulation, recommended dosing is once per day.
A chronic inflammatory disease in which the immune system attacks the protective sheath (myelin) of nerve fibers throughout the central nervous system, multiple sclerosis (MS) can lead to numbness and tingling sensations, double vision, tremors, declines in physical strength and coordination, and other symptoms. In relapsing multiple sclerosis, patients experience periods of worsening symptoms (relapses) typically followed by periods of partial or complete remission. RMS accounts for approximately 85% of initial MS diagnoses.
The most commonly prescribed treatment for RMS, Copaxone had an estimated combined $4.34 billion dollars in sales of its 20mg/mL and 40mg/mL formulations in the one-year period ending on July 31, 2017. Mylan is the first company to receive approval for a generic to Copaxone 40mg/mL. A generic for the 20mg/mL formulation has been available from Sandoz since 2015. Sandoz, in partnership with Momenta Pharmaceuticals, is currently developing its own generic for the 40mg/mL formulation, as are Amneal, Pfizer/Synthon, and Dr. Reddy’s.
Mylan’s generic glatiramer products have already been launched, along with Mylan’s MS Advocate patient support service program, which includes a mobile app for patients, available copay assistance, in-home training on proper drug administration, and access to nurses experienced in MS care and treatment.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.