First Generics Approved for Suboxone
June 15, 2018 – The U.S. FDA has approved generics manufactured by Dr. Reddy’s and Mylan to Indivior’s Suboxone® (buprenorphine/naloxone) sublingual (SL) film. Buprenorphine/naloxone SL film is indicated for maintenance treatment of opioid addiction, as part of a complete treatment plan that includes counseling and psychosocial support.
Dr. Reddy’s launched their generics shortly after approval. The products – available in 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg SL film dosage forms – will be distributed under a Risk Evaluation and Mitigation Strategy (REMS) program. Under such programs, prescribers, pharmacies, and patients must meet certain requirements to ensure the drug is being used appropriately, in a manner that reduces the potential for serious risks associated with the use of buprenorphine products.
Mylan received approval only for 8mg/2mg and 12mg/3mg dosage strengths of buprenorphine/naloxone SL film. The company has not yet announced launch plans.
Due to ongoing patent litigation, the Dr. Reddy’s launch is considered an “at risk” launch. If Indivior wins its appeal regarding patent infringement, Dr. Reddy’s may have to withdraw its Suboxone generic from the market.
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.