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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Healthtrust
QuintilesIMS
Chinese Patent Office
Cantor Fitzgerald
Baxter
Argus Health
Medtronic
US Department of Justice

Generated: May 21, 2018

DrugPatentWatch Database Preview

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 patent family members in twenty-seven countries.

The generic ingredient in PREZISTA is darunavir ethanolate. There are twenty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.
Drug patent expirations by year for PREZISTA
Medical Subject Heading (MeSH) Categories for PREZISTA
Synonyms for PREZISTA
(3R,3AS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ((2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamate compound with ethanol (1:1)
(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)
[(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
33O78XF0BW
635728-39-1
635728-49-3
AB2000167
ABP000914
AC-26777
AK341012
AKOS025149225
BCP9000588
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)
CHEMBL1201127
CS-0750
D06478
Darunavir (Ethanolate)
Darunavir ethanolate
Darunavir ethanolate (JAN)
Darunavir Ethanolate (Prezista)
Darunavir Ethanolate(Prezista)/TMC114
Darunavir-Ethanolate
DARUNAVIR; ETHYL ALCOHOL
HE072167
HY-17041
KS-00000LFB
LS-186602
MFCD18251642
MolPort-028-744-950
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
Prezista (TN)
Prezista;TMC114
QWSHKNICRJHQCY-VBTXLZOXSA-N
S1620
SC-94587
SCHEMBL562454
UNII-33O78XF0BW
W-5737

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 ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for PREZISTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-004 Dec 18, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for PREZISTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 75 mg, 150 mg, 300 mg, 400 mg and 600 mg ➤ Subscribe 2010-06-23
➤ Subscribe Tablets 800 mg ➤ Subscribe 2013-05-14

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Supplementary Protection Certificates for PREZISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB07/038 United Kingdom ➤ Try a Free 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
2007000045 Germany ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR ODER PHARMAZEUTISCH VERTRAEGLICHE SALZE, ESTER ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
C0034 France ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
00283 Netherlands ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Citi
Healthtrust
Julphar
Fuji
McKesson
Fish and Richardson
Argus Health

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