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

 

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
 
Generic Name Manufacturer Name Approval Date Time to Approval*
didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg Aurobindo Pharma Limited 24-Sept-08 8 months
didanosine (ddI) for oral solution (pediatric powder), 10 mg/mL Aurobindo Pharma Limited 08-March-07 14 months
didanosine (ddI) delayed release capsules Barr Laboratories, Inc. 03-Dec-04 6 months
stavudine for oral solution, 1 mg/mL Aurobindo Pharma Limited 29-Dec-08 17 months
stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg) Aurobindo Pharma Limited 29-Dec-08 44 months
stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg) Hetero Drugs Limited 29-Dec-08 21 months
zidovudine 60 mg tablets for pediatric dosing † Aurobindo Pharma Limited 23-July-09 9 months
zidovudine oral solution USP, 50 mg/5 mL, oral solution - zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL) Cipla Limited 26-Jun-08 8 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Matrix Laboratories, Inc. 14-Feb-08 11 months
zidovudine, AZT, azidothymidine, ZDV (100 mg capsule) Cipla Limited 23-May-07 11 months
zidovudine, AZT, azidothymidine, ZDV (100 mg capsule) Aurobindo Pharma LTD. 27-March-06 4 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Aurobindo Pharma Limited 19-Sep-05 10 months
zidovudine oral solution USP, 50 mg/5 mL, oral solution - zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL) Aurobindo Pharma Limited 19-Sep-05 6 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Ranbaxy Laboratories Limited 19-Sep-05 11 months
zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Roxane Laboratories 19-Sep-05 24 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)

    
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