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* |
|---|---|---|---|
| abacavir tablets USP, 300 mg | Mylan Pharmaceuticals, Inc. | 18-June-2012 | 30 months |
Nevirapine tablets USP, 200 mg
|
Prinston Pharmaceutical, Inc.
| 22-May-2012 | 66 months |
nevirapine tablets USP, 200 mg
|
Apotex Corporation
| 22-May-2012 | 14 months |
nevirapine tablets USP, 200 mg
|
Matrix Laboratories Limited
| 22-May-2012 | 50.5 months |
nevirapine tablets USP, 200 mg
|
ScieGen Pharmaceuticals, Inc
| 22-May-2012 | 12 months |
nevirapine tablets USP, 200 mg
|
Mylan Pharmaceuticals, Inc.
| 22-May-2012 | 15 months |
nevirapine tablets USP, 200 mg
|
Hetero Labs Limited, Unit-III
| 22-May-2012 | 66 months |
nevirapine tablets USP, 200 mg
|
Micro Labs Limited
| 22-May-2012 | 11.5 months |
nevirapine tablets USP, 200 mg
|
Strides, Inc.
| 22-May-2012 | 74.5 months |
nevirapine tablets USP, 200 mg
|
Cipla Limited
| 22-May-2012 | 79 months |
nevirapine tablets USP, 200 mg
| Aurobindo Pharma Limited | 22-May-2012 | 77 months |
nevirapine oral suspension USP, 50 mg/5 mL
| Aurobindo Pharma Limited | 15-May-2012 | 84.5 months |
| lamivudine and zidovudine tablets, 150 mg/300 mg | Aurobindo Pharma Limited | 15-May-2012 | 18 months |
| lamivudine and zidovudine tablets, 150 mg/300 mg | Lupin Limited | 15-May-2012 | 52 months |
| lamivudine and zidovudine tablets, 150 mg/300 mg | TEVA Pharmaceuticals USA | 25-May-11 | 47 months |
| zidovudine Injection USP, 10 mg/mL, packaged in 200 mg/20 mL Single-use Vials | PharmaForce Inc. | 06-May-10 | 12 months |
| didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg | Matrix Laboratories Limited | 06-April-2010 | 20 months |
| zidovudine 60 mg tablets for pediatric dosing † | Aurobindo Pharma Limited | 23-July-09 | 9 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 |
| didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg | Aurobindo Pharma Limited | 24-Sept-08 | 8 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 |
| didanosine (ddI) for oral solution (pediatric powder), 10 mg/mL | Aurobindo Pharma Limited | 08-March-07 | 14 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 |
| didanosine (ddI) delayed release capsules | Barr Laboratories, Inc. | 03-Dec-04 | 6 months |
* Including time until patent and exclusivity protections for originator product expires.
† Not marketed in the United States