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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)

Page Last Updated: 02/04/2014
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