Generic for Tamiflu Approved
August 3, 2016 – The FDA approved the first generic for Roche’s Tamiflu® (oseltamivir) capsules. The generic manufacturer, Natco Pharma, and its U.S. distribution partner, Alvogen, can launch the generic capsules prior to the expiration of Tamiflu’s last exclusivity on Feb. 23, 2017. Oseltamivir is an oral neuraminidase inhibitor that is indicated to treat influenza (flu) for patients who are at least two weeks old and who have had flu symptoms for no longer than two days. Typically patients take it twice a day for five days. The medication can also be taken for periods of up to 12 weeks, to reduce the chance of getting flu for individuals who are at high risk and who are one-year-old or older. An exact release date has not been set, but Natco/Alvogen will have 180 days of exclusivity before other generics can enter the U.S. market. Generics for Tamiflu Oral Suspension are not yet FDA approved. IMS Health estimates that 2015 sales of Tamiflu accounted for $403 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.