Norvir Tablet Generics Launched
March 20, 2018 – West-Ward Pharmaceuticals, a subsidiary of Hikma Pharmaceuticals, has launched its generic for AbbVie’s Norvir® (ritonavir) tablets. This is the first AB-rated generic for Norvir, and is eligible for 180 days of exclusivity.
Indicated to treat HIV-1 infection in combination with other antiretroviral drugs, ritonavir is a protease inhibitor that helps prevent the replication of HIV in the body and boost the efficacy of other drugs in its class. It is approved for use in patients as young as one month of age. Recommended dosing varies based on the patient’s age and treatment plan.
Ritonavir carries a black box warning, indicating that it can cause severe side effects if used in conjunction with certain medications or supplements.
No generics are currently available for Norvir capsules or solution. The estimated total sales of all forms and dosage strengths of brand name Norvir in 2017 reached $214 million in the U.S., according to IQVIA.
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.