Compound

Brand name

Zidovudine
(AZT)

Retrovir

Didanosine 
(ddI) 

Videx

Zalcitabine 
(ddC)

Hivid

Stavudine 
(d4T)

Zerit

Lamivudine 
(3TC)

Epivir

Abacavir

Ziagen

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)

Search on November 19, 1999

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, 19-11-99

 1462

66

6

158

191

2

Standard Adult Dosage 

200mg 3X daily, or
300mg 2X daily

200mg 2X daily

.

40mg 2X daily

150mg 2X daily

300mg 2X daily

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).  Search on November 19, 1999

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, 19-11-99

 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

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.  November 19, 1999.

gov: 42
non-gov: 23

gov: 20
non-gov: 20

gov: 22
non-gov 17

Number of grants in CRISP database, Nov 19, 1999.

 151

 53

 1

Standard Adult Dosage

 200mg 2X daily

 400 2X daily

 .