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Multi-class Combination Products

Brand Name Atripla Generic Name Manufacturer Name Approval Date 12-July-06 Time to Approval 2.5 months efavirenz, emtricitabine and Bristol-Myers Squibb and Gilead tenofovir disoproxil Sciences fumarate emtricitabine, rilpivirine, and Gilead Sciences tenofovir disoproxil fumarate

Complera

10-August-11

6 months

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)


Brand Name Combivir Emtriva Epivir Epzicom Hivid Retrovir Trizivir Truvada Videx EC Videx Viread Zerit Ziagen Generic Name lamivudine and zidovudine emtricitabine, FTC lamivudine, 3TC abacavir and lamivudine Manufacturer Name GlaxoSmithKline Gilead Sciences GlaxoSmithKline GlaxoSmithKline Approval Date 27-Sep-97 02-Jul-03 17-Nov-95 02-Aug-04 19-Jun-92 19-Mar-87 14-Nov-00 02-Aug-04 31-Oct-00 9-Oct-91 26-Oct-01 24-Jun-94 17-Dec-98 Time to Approval 3.9 months 10 months 4.4 months 10 months 7.6 months 3.5 months 10.9 months 5 months 9 months 6 months 5.9 months 5.9 months 5.8 months

zalcitabine, dideoxycytidine, Hoffmann-La Roche ddC (no longer marketed) zidovudine, azidothymidine, GlaxoSmithKline AZT, ZDV abacavir, zidovudine, and lamivudine tenofovir disoproxil fumarate and emtricitabine enteric coated didanosine, ddI EC GlaxoSmithKline Gilead Sciences, Inc. Bristol Myers-Squibb

didanosine, dideoxyinosine, Bristol Myers-Squibb ddI tenofovir disoproxil fumarate, TDF stavudine, d4T abacavir sulfate, ABC Gilead Bristol Myers-Squibb GlaxoSmithKline

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)


Brand Name Edurant Intelence Rescriptor Sustiva Viramune
(Immediate Release)

Generic Name rilpivirine etravirine delavirdine, DLV efavirenz, EFV nevirapine, NVP

Manufacturer Name Tibotec Therapeutics Tibotec Therapeutics Pfizer Bristol Myers-Squibb Boehringer Ingelheim Boehringer Ingelheim

Approval Date 20-May-11 18-Jan-08 4-Apr-97 17-Sep-98 21-Jun-96 25-Mar-11

Time to Approval 10 months 6 months 8.7 months 3.2 months 3.9 months 9.9 months

Viramune XR(Extended nevirapine, NVP


Release)

Protease Inhibitors (PIs)


Brand Name Agenerase Aptivus Crixivan Fortovase Invirase Kaletra Lexiva Norvir Prezista Reyataz Viracept Generic Name amprenavir, APV tipranavir, TPV indinavir, IDV, saquinavir (no longer marketed) saquinavir mesylate, SQV lopinavir and ritonavir, LPV/RTV Fosamprenavir Calcium, FOS-APV ritonavir, RTV darunavir atazanavir sulfate, ATV nelfinavir mesylate, NFV Manufacturer Name GlaxoSmithKline Boehringer Ingelheim Merck Hoffmann-La Roche Hoffmann-La Roche Abbott Laboratories GlaxoSmithKline Abbott Laboratories Tibotec, Inc. Bristol-Myers Squibb Agouron Pharmaceuticals Approval Date 15-Apr-99 22-Jun-05 13-Mar-96 7-Nov-97 6-Dec-95 15-Sep-00 20-Oct-03 1-Mar-96 23-Jun-06 20-Jun-03 14-Mar-97 Time to Approval 6 months 6 months 1.4 months 5.9 months 3.2 months 3.5 months 10 months 2.3 months 6 months 6 months 2.6 months

Fusion Inhibitors
Brand Name Fuzeon Generic Name enfuvirtide, T-20 Manufacturer Name Hoffmann-La Roche & Trimeris Approval Date 13-Mar-03 Time to Approval 6 months

Entry Inhibitors - CCR5 co-receptor antagonist


Brand Name Selzentry Generic Name maraviroc Manufacturer Name Pfizer Approval Date 06-August-07 Time to Approval 8 months

HIV integrase strand transfer inhibitors


Brand Name Isentress Generic Name raltegravir Manufacturer Name Merck & Co., Inc. Approval Date 12--Oct-07 Time to Approval 6 months

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