FDA Approval of Generic ARVs: Nevirapine and Combivir Now Off-Patent in the U.S.

Since the last issue of HTB, the U.S. Food and Drug Administration (FDA) has granted approval or tentative approval for the following new generic ARV products.

Drug and FormulationManufacturer, CountryApproval Date
Lopinavir/ritonavir 200 mg / 50 mg combined tabletsHetero, India23 May 2012
Nevirapine 200 mg tablets **10 manufacturers:

Apotex, Canada

Aurobindo, India

Cipla, India

Hetero, India

Matrix, India

Micro, India

Mylan, U.S./India

Prinston Pharma, U.S.

ScieGen Pharma, U.S.

Strides, India

22 May 2012
Nevirapine oral suspension **Aurobindo, India22 May 2012
AZT/3TC combination tablets, 300 mg / 150 mg **Lupin, India15 May 2012
AZT/3TC combination tablets, 300 mg / 150 mg **Aurobindo, India15 May 2012
Nevirapine scored tablets for oral suspension: 50 mg and 100 mg (for children >5 kg)Cipla, India30 April 2012

Key: ** Full approval; FDC: Fixed Dose Combination

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the U.S. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the U.S.

Full approval (**) indicates that these formulations can be marketed in the U.S. because the patent for the orginial drug has now expired.

Fixed Dose Combinations are reviewed for PEPFAR under the FDA guidance titled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV."

This document was developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.

Effective patent dates are listed in the agency's publication titled "Approved Drug Products With Therapeutic Equivalence Evaluations," also known as the "Orange Book."

An updated list of generic tentative approvals (now at 140) is available on the FDA website.

Comment

The most notable developments this year have been the full license approvals that allows marketing in the U.S. for generic versions of nevirapine and the combined formulation of AZT/3TC.

Generic versions of AZT, 3TC and nevirapine are already used in some European countries. For nevirapine this includes Ireland, Spain and Portugal, although for reasons that are not clear, UK access is not expected until 2013.

Source: FDA list serve:

www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

Links to external websites are current at time of posting but not maintained.