Baraclude Available as a Generic
September 3, 2014 – The U.S. Food and Drug Administration (FDA) approved entecavir, the generic version of Baraclude (manufactures by Bristol-Myers Squibb). Entecavir is manufactured by Teva Pharmaceuticals which began to distribute the generic medication immediately after gaining approval.
Entecavir is a nucleoside analog anti-viral drug used to control chronic hepatitis B by preventing the replication of the virus that causes hepatitis B. Entecavir is for patients two years of age and older who are at least 22 pounds and who have active disease with liver damage. Dosage forms available are 0.5mg and 1mg tablets.
Teva has 180 days of generic exclusivity before other generics can enter the market. According to IMS Health, Baraclude had annual U.S. sales of approximately $328 million for the twelve month period ending Jun. 30, 2014.
If you have any questions you can contact our Client Services Call Center at 1-877-723-6005.
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 a 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.