Background Information on Fourteen FDA Approved HIV/AIDS
Drugs
|
This page is best viewed in conjunction with CPT's page
on the U.S.
Government Role in the Development of HIV/AIDS drugs.
Version 1.41, updated on June 8, 2000.
Thiru Balasubramaniam
Sources: FDA Orange Book, US Patent and Trademark Office
database, and ACTIS database.
The ACTIS database search was conducted on November 19,
1999. The CRISP database search was was conducted on November 19, 1999.
These databases are updated frequently; therefore some of the information
pertaining to the ACTIS and CRISP databases needs to be updated.
Nucleoside Analogue Reverse
Transcriptase Inhibitors (RT)
| Compound
Brand name |
Zidovudine
(AZT)
Retrovir
|
Didanosine
(ddI)
Videx
|
Zalcitabine
(ddC)
Hivid
|
Stavudine
(d4T)
Zerit
|
Lamivudine
(3TC)
Epivir
|
|
| Marketing Company |
Glaxo
Wellcome
|
Bristol-
Myers Squibb
|
Hoffmann-
La Roche
|
Bristol-
Myers Squibb
|
Glaxo
Wellcome
|
Glaxo
Wellcome
|
| Inventor |
Michigan Cancer Foundation (originally synthesized
compound under an NCI grant)
Glaxo Wellcome holds key use patent
|
NIH
|
Michigan Cancer Foundation (originally synthesized
compound under an NCI grant)
The United States of America holds key use patent
|
Michigan Cancer Foundation (originally synthesized
compound under an NCI grant)
Yale University holds key use patent
|
BioChem Pharma
|
University of Minnesota (Dr.Robert Vince
originally synthesized the "carbovir" compounds under an NIH grant)
Burroughs Wellcome holds the key use patent
|
| Filing of Application for US FDA Approval |
2-Dec-86
|
29-Mar-91
|
31-Oct-91
|
28-Dec-93
|
30-Jun-95
|
. |
| Date of US FDA Approval |
19-Mar-87
|
9-Oct-91
|
19-Jun-92
|
24-Jun-94
|
17-Nov-95
|
17-Dec-98
|
| Filing of Key Patent Application |
17-Sep-85
|
11-Aug-87
|
11-Aug-87
|
17-Dec-86
|
8-Feb-89
|
22-Dec-89
|
| Date of Key Patent Approval |
9-Feb-88
|
29-Aug-89
|
7-Nov-89
|
18-Dec-90
|
10-Sep-91
|
23-Jul-91
|
| US FDA Orange Book
Patent(s)
Data Exclusivity Expiration
Patent Expiration
|
Patent(s): Various
Data Exclusivity: Expired
Patent Expiration:
Sep 17, 2005
|
Patent(s): Various
Data Exclusivity: Expired
Patent Expiration:
Aug 29, 2006
|
Patent(s): Various
Data Exclusivity: Jun
19,1999
Patent Expiration:
Nov 07, 2006-
Jul 02, 2008
|
Patent(s): Various
Data Exclusivity:
Jun 24,1999
Patent Expiration:
Jun 25, 2008
|
Patent(s): Various
Data Exclusivity
Nov 17, 2000-
Dec 08, 2001
Patent Expiration:
Feb 08, 2009-
May 18, 2016
|
Patent(s): Various
Data Exclusivity Expiration:
Dec 17,2003-
Jun 17,2004
Patent Expiration:
Jun 26, 2009-
Dec 26, 2009
|
| Number of clinical trials (and patients) in NDA |
Protocol 02: 282 patients
|
ACTG 116A: 617 patients
ACTG 116B/117: 913 patients
|
ACTG 175: 2467 patients CPCRA 002: 467 patients
ACTG 114: 635 patients
|
AI455-019: 822 patients
|
A3001: 366 patients B3001: 129 patients
A3002: 254 patients B3002: 223 patients
|
CNAAB 3003: 173 patients
CNAA 3006: 205 patients
|
Sponsor(s) of clinical
trials in NDA |
Protocol 02: Burroughs Wellcome
|
ACTG 116A: NIAID/BMS
ACTG 116B/117:
NIAID/BMS
|
ACTG 175: NIAID/ BMS/Glaxo Wellcome
CPCRA 002: BMS/NIAID/ Hoffmann-La Roche
ACTG 114: NIAID/ Hoffmann La Roche
|
AI455-019: BMS
|
. |
CNAAB 3003: Glaxo Wellcome
CNAA 3006: Glaxo Wellcome
|
Duration of
clinical trials in NDA (analysis time) |
Protocol 02: Median-18 weeks
|
. |
. |
. |
A3001: 24 weeks B3001: 24 weeks A3002: 24
weeks B3002: 24 weeks
|
CNAAB 3003: 24 weeks
CNAAB 3006: 24 weeks
|
|
Number of clinical trials in ACTIS database
sponsored by: government (including co-sponsorship with pharmaceutical
companies) and non-gov (pharmaceutical companies and/or universities)
|
gov: 314
non-gov: 189
|
gov: 131
non-gov: 59
|
gov: 43
non-gov: 26
|
gov: 53
non-gov: 56
|
gov: 65
non-gov: 54
|
gov: 19
non-gov: 29
|
| Number of grants in CRISP database |
1462
|
66
|
6
|
158
|
191
|
2
|
| Standard Adult Dosage |
200mg 3X daily, or
300mg 2X daily
|
200mg 2X daily
|
0.75mg 3X daily
|
40mg 2X daily
|
150mg 2X daily
|
300mg 2X daily
|
Protease Inhibitors
Compound
Brand name |
Saquinavir
Invirase ; Fortovase
|
Ritonavir
Norvir
|
Indinavir
Crixivan
|
Nelfinavir
Viracept
|
Amprenavir
Agenerase
|
Lopinavir(80%) + Ritonavir(20%)
Kaletra
|
| Marketing Company |
Hoffmann-La Roche
|
Abbott
|
Merck
|
Agouron
|
Glaxo Wellcome
|
Abbott
|
| Inventor |
Hoffman-La Roche
|
Abbott
|
Merck
|
Agouron and the pharmaceutical division
of Japan Tobacco
|
Vertex
|
Abbott
|
| Filing of Application for US FDA Approval |
31-Aug-95
|
21-Dec-95
|
31-Jan-96
|
26-Dec-96
|
16-Oct-98 |
31-Mar-00 |
| Date of US FDA Approval |
6-Dec-95
|
1-Mar-96
|
13-Mar-96
|
14-Mar-98
|
15-Apr-99
|
15-Sep-00
|
| Filing of Key Patent Application |
19-Nov-90
|
25-Apr-95
|
7-May-93
|
2-Feb-94
|
24-Nov-93
|
.
|
| Date of Key Patent Approval |
23-Mar-93
|
30-Jul-96
|
9-May-95
|
16-Jan-96
|
17-Dec-96
|
.
|
| US FDA Orange Book
Patent(s)
Data Exclusivity Expiration
Patent Expiration |
Patent: 5196438
Data Exclusivity Expiration:
Dec 06, 2000
Patent Expiration:
Nov 19, 2010
|
Patent(s): Various
Data Exclusivity Expiration:
Mar 01,2001
Patent Expiration:
Dec 29, 2012-
Jul 15, 2014
|
Patent(s): Various
Data Exclusivity Expiration:
Mar 13,2001
Patent Expiration:
May 07, 2013
|
Patent(s): Various
Data Exclusivity Expiration:
Mar 14,2002
Patent Expiration:
Oct 07, 2013
|
Patent: 5585397
Data Exclusivity Expiration:
Apr 15, 2004
Patent Expiration:
Dec 17,2013
|
Patents: Various
: Data Exclusivity Expiration:
Sep 15, 2003
Patent Expiration:
Dec 29, 2012 -
June 26, 2016
|
Number of clinical trials
(and patients) in NDA |
V13330: 92 patients (conducted in Italy)
ACTG 229: 295 patients
NV14256: 970 patients
|
M94-245: 356 patients
M94-247:1086 patients
M94-462: 141 patients
|
Merck 028: 996 patients (conducted
in Brazil)
Merck 033: 266 patients
|
Agouron 506: 308 patients
Agouron 511: 297 patients
|
PROAB 3001: 232 patients
PROAB 3006: 504 patients
|
.
|
| Sponsor(s) of clinical trials in NDA |
ACTG 229 NIAID/ Hoffmann - La Roche
NV14256: Hoffmann - La Roche
|
M94-245:Abbott
M94-247:Abbott
M94-462:Abbott
|
Merck 028: Merck
Merck 033: Merck
|
Agouron 506: Agouron
Agouron 511: Agouron
|
PROAB 3001: Glaxo Wellcome
PROAB 3006: Glaxo Wellcome
|
.
|
| Duration of clinical trials in NDA (analysis time) |
ACTG 229: 24 weeks |
M94-245:36 weeks
M94-247:36 weeks
M94-462:48 weeks
|
. |
. |
PROAB 3001:48 weeks
PROAB 3006:48 weeks
|
.
|
Number of trials in ACTIS database sponsored by government
(including co-sponsorship with pharmaceutical companies)
and non-gov (pharmaceutical companies and/or universities) |
gov: 25
non-gov: 32
|
gov: 30
non-gov: 28
|
gov: 53
non-gov: 54
|
gov: 40
non-gov: 41
|
gov: 14
non-gov: 11
|
.
|
| Number of grants in CRISP database |
29
|
43
|
91
|
25
|
1
|
.
|
| Standard Adult Dosage |
1,200mg 3X daily
|
600mg 2X daily
|
800mg 3X daily
|
750mg 3x daily
|
1200mg 2X daily
|
500mg 2X daily
|
Non-Nucleoside Reverse Transcriptase
Inhibitors (NNRTI)
Compound
Brand name |
Nevirapine
Viramune
|
Delavirdine
Rescriptor
|
Efavirenz
Sustiva
|
| Marketing Company |
USA: Roxanne Laboratories
Rest of the world: Boehringer Ingelheim Pharmaceuticals
|
Pharmacia and Upjohn
|
Dupont Pharmaceuticals
|
| Inventor |
Boehringer Ingelheim Pharmaceuticals
|
Pharmacia and Upjohn
|
Merck
|
| Filing of Application for US FDA Approval |
23-Feb-96
|
15-Jul-96
|
11-Jun-98
|
| Date of US FDA Approval |
21-Jun-96
|
4-Apr-97
|
17-Sep-98
|
| Filing of Key Patent Application |
13-Jul-93
|
22-Feb-94
|
2-Jun-95
|
| Date of Key Patent Approval |
22-Nov-94
|
8-Oct-96
|
21-May-96
|
| US FDA Orange Book Exclusivity
Patent(s)
Exclusivity Expiration
Patent Expiration |
Patent:: 5366972
Data Exclusivity Expiration:
Jun 21,2001- Sep 11,2001
Patent Expiration: Nov 22, 2011
|
Patent: 5563142
Data Exclusivity Expiration:
Apr 04,2002
Patent Expiration:
Oct 08,2013
|
Patent(s): Various
Data Exclusivity Expiration: Sep 17, 2003
Patent Expiration:
Aug 07,2012- Sep 02,2014
|
| Number of clinical trials (and patients) in NDA |
ACTG 241: 398 patients
BI Trial 1046: 151 patients
|
Study 0017: 1,190 patients
Study 0021: 718 patients
ACTG: 261 544 patients
|
DMP 266-006 : 450 patients
DMP 260-020: 282 patients
ACTG 364: 196 patients
|
| Sponsor(s) of clinical trials in NDA |
ACTG 241: NIAID/ Bristol-Myers Squibb/ Glaxo
Wellcome
BI Trial 1046: Boehringer Ingelheim Pharmaceuticals
|
Study 0017: Pharmacia & Upjohn
Study 0021: Pharmacia & Upjohn
ACTG 261: NIAID
|
DMP 266-006: DuPont Merck
DMP 260-020: DuPont Merck
ACTG 364: NIAID
|
| Duration of clinical trials in NDA (analysis time) |
ACTG 241: 48 weeks
BI Trial 1046: 76 weeks
|
ACTG 261: 48 weeks
|
DMP 266-006: 24 weeks
DMP 260-020: 24 weeks
ACTG 364: 48 weeks
|
| Number of trials in ACTIS database sponsored by government
(including co-sponsorship with pharmaceutical companies) and private pharmaceutical
companies |
gov: 42
non-gov: 23
|
gov: 20
non-gov: 20
|
gov: 22
non-gov 17
|
| Number of grants in CRISP database |
151
|
53
|
1
|
| Standard Adult Dosage |
200mg 2X daily
|
400mg 3X daily
|
600mg 1X daily
|
Send comments or suggestions to Mike Palmedo
mpalmedo@cptech.org