Generics to Tribenzor
November 2016 - The US FDA recently approved multiple AB rated generics of Tribenzor, manufactured by Daiichi Sankyo. Generic companies including Par Pharmaceutical, Teva Pharmaceutical Industries and Torrent Pharmaceuticals Limited, now offer the generic version of the fixed dose combination of olmesartan, amlodipine and hydrochlorothiazide indicated for treating high blood pressure. It includes an angiotensin II receptor blocker (ARB), a calcium channel blocker and a diuretic. Teva’s generic is already available, as is an authorized generic from Sun Pharmaceutical Industries. For the 12-month period that ended on Aug. 31, 2016, IMS Health estimates that sales of Tribenzor accounted for $240 million in the United States.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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.