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Last Updated: January 28, 2020

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PREZISTA Drug Profile

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Which patents cover Prezista, and when can generic versions of Prezista launch?

Prezista is a drug marketed by Janssen Prods and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-two patent family members in twenty-seven countries.

The generic ingredient in PREZISTA is darunavir. There are twenty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the darunavir profile page.

US ANDA Litigation and Generic Entry Outlook for Prezista

A generic version of PREZISTA was approved as darunavir by TEVA PHARMS USA on January 28th, 2020.

  Start Trial

Drug patent expirations by year for PREZISTA
Drug Prices for PREZISTA

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Recent Clinical Trials for PREZISTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Frederick National Laboratory for Cancer ResearchPhase 4
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
University of Cape TownPhase 1

See all PREZISTA clinical trials

Recent Litigation for PREZISTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
JANSSEN PRODUCTS, L.P. v. ZYDUS PHARMACEUTICALS (USA) INC.2020-01-23
JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC2018-12-26
Genzyme Corporation v. Fresenius Kabi USA, LLC2018-12-06

See all PREZISTA litigation

PTAB Litigation
PetitionerDate
Lupin Limited2015-04-09

See all PREZISTA litigation

Synonyms for PREZISTA
((1S,2R)-3-(((4-Aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-(phenylmethyl)propyl)-carbamic acid (3R,3aS,6aR)-hexahydrofurano(2,3-b)furan-3-yl ester
(3-((4-aminobenzenesulfonyl)isobutylamino)-1-benzyl-2-hydroxypropyl)carbamic acid hexahydrofuro(2,3-b)furan-3-yl ester
(3R,3aS,6aR)-Hexahydrofuro(2,3-b)furan-3-yl N-((1S,2R)-1-benzyl-2-hydroxy-3-(N(sup 1)-isobutylsulfanilamido)propyl)carbamate
(3R,3aS,6aR)-Hexahydrofuro(2,3-b)furan-3-yl N-((1S,2R)-1-benzyl-2-hydroxy-3-(N1-isobutylsulfanilamido)propyl)carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ((2S,3R)-4-((4-amino-N-isobutylphenyl)sulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ((2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl [(2S,3R)-4-{[(4-aminophenyl)sulfonyl](2-methylpropyl)amino}-3-hydroxy-1-phenylbutan-2-yl]carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-((1S,2R)-1-benzyl-2-hydroxy-3-(N(1)-isobutylsulfanilamido)propyl)carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-3-hydroxy-4-[N-(2-methylpropyl)(4-aminobenzene)sulfonamido]-1-phenylbutan-2-yl]carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-3-hydroxy-4-[N-(2-methylpropyl)4-aminobenzenesulfonamido]-1-phenylbutan-2-yl]carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-4-[(4-aminobenzene)(2-methylpropyl)sulfonamido]-3-hydroxy-1-phenylbutan-2-yl]carbamate
(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl((2S,3R)-4-((4-amino-N-isobutylphenyl)sulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamatecompoundwithethanol(1:1)
(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-YL(1S,2R)-3-[[(4-AMINOPHENYL)SULFONYL](ISOBUTYL)AMINO]-1-BENZYL-2-HYDROXYPROPYLCARBAMATE
(3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate
(3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-neopentylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate
[(1S,2R)-3-[[(4-Aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenyl-methyl)propyl]carabamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]-furan-3-yl ester
[(3aS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(1S,2R)-3-[(4-aminophenyl)sulfonyl-isobutyl-amino]-1-benzyl-2-hydroxy-propyl]carbamate
[(3aS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate
[(3aS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate ethanol
[(3aS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate;ethanol
[(S)-3-[(4-Amino-benzenesulfonyl)-isobutyl-amino]-2-hydroxy-1-((R)-phenylmethyl)-propyl]-carbamic acid (3R,3aS,6aR)-(hexahydro-furo[2,3-b]furan-3-yl) ester
[14C]-Darunavir ethanolate
{(1S,2R)-3-[(4-Amino-benzenesulfonyl)-isobutyl-amino]-1-benzyl-2-hydroxy-propyl}-carbamic acid (3R,3aS,6aR)-(hexahydro-furo[2,3-b]furan-3-yl) ester
1097732-88-1
1133378-37-6
206361-99-1
2f80
2f81
2f8g
2hs1
2hs2
2idw
2ien
33O78XF0BW
361D991
3bvb
3cyw
3d1z
3d20
3ekt
3ggu
3lzs
3lzu
3lzv
3ogp
3pwm
3qoz
3s53
3s54
3so9
3t3c
3tkw
3ttp
3u7s
4hla
4ll3
618109-00-5
635728-39-1
635728-49-3
AB0032516
AB01565837_02
AB2000167
ABP000914
AC-26777
AC-26778
AC1L4U4V
AIDS073035
AK162146
AK341012
AKOS015966592
AKOS025149225
AN-1069
API0000506
AS-35215
BC677684
BCP0726000058
BCP9000587
BCP9000588
BDBM8125
Carbamic acid, ((1S,2R)-3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-(phenylmethyl)propyl)-, (3R,3aS,6aR)-hexahydrofurano(2,3-b)furan-3-yl ester
Carbamic acid, ((1S,2R)-3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-(phenylmethyl)propyl)-, (3R,3aS,6aR)-hexahydrofuro(2,3-b)furan-3-yl ester, compd. with ethanol (1:1)
Carbamic acid, [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-, (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester
CAS-206361-99-1
CHEBI:367163
CHEMBL1201127
CHEMBL1323
CJBJHOAVZSMMDJ-HEXNFIEUSA-N
CS-0749
CS-0750
CTK8E7239
D03656
D06478
Darunavir
Darunavir (DRV)
Darunavir (Ethanolate)
Darunavir (USAN/INN)
Darunavir [USAN:INN:BAN]
Darunavir [USAN]
Darunavir & alpha1-acid glycoprotein
Darunavir & human serum albumin
Darunavir ethanolate
Darunavir ethanolate (JAN)
Darunavir Ethanolate (Prezista)
Darunavir Ethanolate(Prezista)/TMC114
Darunavir-d9
Darunavir, >=98% (HPLC)
DarunavirEthanolate
Darunavirum
Darunavirum [INN-Latin]
DB01264
DRV & AAG
DRV & HSA
DSSTox_CID_26779
DSSTox_GSID_46779
DSSTox_RID_81898
DTXSID0046779
HMS3715I13
HSDB 7788
HY-17040
HY-17041
J-013483
KS-00000LFB
KS-1469
LS-186602
LS-187026
LS-187772
LS-191295
MC-114
MFCD09260006
MolPort-003-846-141
MolPort-028-744-950
N-((1S,2R)-3-(((4-Aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-benzylpropyl)((1S,2R,5R)-4,6-dioxabicyclo(3.3.0)oct-2-yloxy)carboxamide
N-[(1S,2R)-3-[[(4-Aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester compd. with ethanol
NCGC00168773-01
Prezista (TN)
Prezista Naive
Prezista;TMC114
Prezista(TM)
QWSHKNICRJHQCY-VBTXLZOXSA-N
RTX-013373
S1620
SB17490
SC-94587
SCHEMBL118546
SCHEMBL562454
ST24046418
SW219052-1
TMC 114
TMC 41629
TMC-114
TMC114
TMC41629
Tox21_112634
UIC 94017
UIC-94017
UIC-940T
UIC-96017
UNII-33O78XF0BW
UNII-YO603Y8113
W-5398
W-5737
X5831
YO603Y8113
ZINC3955219
Paragraph IV (Patent) Challenges for PREZISTA
Tradename Dosage Ingredient NDA Submissiondate
PREZISTA TABLET;ORAL darunavir 021976 2013-05-14
PREZISTA TABLET;ORAL darunavir 021976 2010-06-23

US Patents and Regulatory Information for PREZISTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREZISTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PREZISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0810209 0790034-3 Sweden   Start Trial PRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
0810209 SPC/GB07/038 United Kingdom   Start Trial PRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212; SPC EXTENSION AUTHORISATION: EU/1/06/380/001 - 008, 20070212
0810209 SZ 33/2007 Austria   Start Trial PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE
2487162 PA2016040 Lithuania   Start Trial PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
0810209 CA 2007 00017 Denmark   Start Trial PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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