Generic Launched for Epiduo
July 28, 2017 – Teva has launched an AB-rated generic to Galderma Laboratories’ Epiduo® (adapalene 0.1%/benzoyl peroxide 2.5%) topical gel. The drug contains antibacterial and anti-inflammatory components used to treat acne in patients nine years of age and older. Patients should apply a pea-sized amount of the gel once daily to affected regions of the skin after ensuring that these areas are clean and dry. Patients should also avoid excessive exposure to both natural and artificial sunlight, or use a strong sunscreen, as adapalene, a retinoid, increases the risk of sunburn.
Teva’s generic will be available in both 45mg tubes and 45mg pumps, and is expected to have 180-day exclusivity. According to Quintiles IMS, annual U.S. sales of Epiduo through the end of March 2017 totaled $251 million. Galderma Laboratories’ Epiduo® Forte (adapalene 0.3%/benzoyl peroxide 2.5%) topical gel remains brand-only.
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.