• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Consumers

  • Print
  • Share
  • E-mail
?
-

Resources for You

Approved generic formulations of antiretroviral drugs used in the treatment of HIV infection

 

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
 
Generic NameManufacturer NameApproval DateTime to Approval*

lamivudine and zidovudine tablets USP,
150 mg/300 mg

Hetero Labs Limited03-Feb-201430 months
abacavir tablets USP, 300 mgMylan Pharmaceuticals, Inc.18-June-201230 months

Nevirapine tablets USP, 200 mg

Prinston Pharmaceutical, Inc.

22-May-201266 months

nevirapine tablets USP, 200 mg

Apotex Corporation

22-May-201214 months

nevirapine tablets USP, 200 mg

Matrix Laboratories Limited

22-May-201250.5 months

nevirapine tablets USP, 200 mg

ScieGen Pharmaceuticals, Inc

22-May-201212 months

nevirapine tablets USP, 200 mg

Mylan Pharmaceuticals, Inc.

22-May-201215 months

nevirapine tablets USP, 200 mg

Hetero Labs Limited, Unit-III

22-May-201266 months

nevirapine tablets USP, 200 mg

Micro Labs Limited

22-May-201211.5 months

nevirapine tablets USP, 200 mg

Strides, Inc.

22-May-201274.5 months

nevirapine tablets USP, 200 mg

Cipla Limited

22-May-201279 months

nevirapine tablets USP, 200 mg

Aurobindo Pharma Limited22-May-201277 months

nevirapine oral suspension USP, 50 mg/5 mL

Aurobindo Pharma Limited15-May-201284.5 months
lamivudine and zidovudine tablets, 150 mg/300 mgAurobindo Pharma Limited15-May-201218 months
lamivudine and zidovudine tablets, 150 mg/300 mgLupin Limited15-May-201252 months
lamivudine and zidovudine tablets, 150 mg/300 mgTEVA Pharmaceuticals USA25-May-1147 months
zidovudine Injection USP, 10 mg/mL, packaged in 200 mg/20 mL
Single-use Vials
PharmaForce Inc.06-May-1012 months
didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mgMatrix Laboratories Limited06-April-201020 months
zidovudine 60 mg tablets for pediatric dosing †Aurobindo Pharma Limited23-July-099 months

stavudine for oral solution,

1 mg/mL

Aurobindo Pharma Limited29-Dec-0817 months
stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg)Aurobindo Pharma Limited29-Dec-0844 months
stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg)Hetero Drugs Limited29-Dec-0821 months
didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mgAurobindo Pharma Limited24-Sept-088 months
zidovudine oral solution USP, 50 mg/5 mL, oral solution - zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL)Cipla Limited26-Jun-088 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet)Matrix Laboratories, Inc.14-Feb-0811 months
zidovudine, AZT, azidothymidine, ZDV (100 mg capsule)Cipla Limited23-May-0711 months
didanosine (ddI) for oral solution (pediatric powder), 10 mg/mLAurobindo Pharma Limited08-March-0714 months
zidovudine, AZT, azidothymidine, ZDV (100 mg capsule)Aurobindo Pharma LTD.27-March-064 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet)Aurobindo Pharma Limited19-Sep-0510 months
zidovudine oral solution USP, 50 mg/5 mL, oral solution - zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL)Aurobindo Pharma Limited19-Sep-056 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet)Ranbaxy Laboratories Limited19-Sep-0511 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet)Roxane Laboratories19-Sep-0524 months
didanosine (ddI) delayed release capsulesBarr Laboratories, Inc.03-Dec-046 months

* Including time until patent and exclusivity protections for originator product expires.

† Not marketed in the United States

Drugs Used in the Treatment of HIV Infection (approved innovator products)

Drugs Used in the Treatment of Pediatric HIV Infection (approved innovator products)