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Generated: December 12, 2018

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PREZISTA Drug Profile

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Which patents cover Prezista, and what generic alternatives are available?

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. Four 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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Sign Up ➤ Sign Up
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 Date
➤ Subscribe Tablets 75 mg, 150 mg, 300 mg, 400 mg and 600 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 800 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PREZISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016040 Lithuania ➤ Sign Up PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
2007 00017 Denmark ➤ Sign Up PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
/2016 Austria ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Army
Mallinckrodt
Colorcon
Merck
Covington
Federal Trade Commission
Medtronic
Express Scripts

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