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Generated: November 17, 2018

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Darunavir ethanolate - Generic Drug Details

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What are the generic drug sources for darunavir ethanolate and what is the scope of darunavir ethanolate patent protection?

Darunavir ethanolate is the generic ingredient in two branded drugs marketed by Janssen Prods and Teva Pharms Usa, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for darunavir ethanolate. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Medical Subject Heading (MeSH) Categories for darunavir ethanolate
Synonyms for darunavir ethanolate
(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 (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
Tentative approvals for DARUNAVIR ETHANOLATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial800MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial600MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial400MGTABLET;ORAL

US Patents and Regulatory Information for darunavir ethanolate

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 021976-004 Dec 18, 2008 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 Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 DISCN 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
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 darunavir ethanolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 ➤ 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 021976-006 Nov 9, 2012 ➤ 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 021976-001 Jun 23, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 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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International Patents for darunavir ethanolate

Country Document Number Estimated Expiration
Cyprus 1112172 ➤ Try a Free Trial
Denmark 1567529 ➤ Try a Free Trial
Cyprus 1117928 ➤ Try a Free Trial
Japan 4864320 ➤ Try a Free Trial
Portugal 2314591 ➤ Try a Free Trial
South Korea 20100119906 ➤ Try a Free Trial
South Korea 20050008715 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for darunavir ethanolate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2016 Austria ➤ Try a Free Trial 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
90034-3 Sweden ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
C0034 France ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
2017 00002 Denmark ➤ Try a Free Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
16/063 Ireland ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
90003-6 Sweden ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REG. NO/DATE: EU/1/14/967 20141121
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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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Medtronic
Daiichi Sankyo
Dow
UBS
Harvard Business School
Mallinckrodt
Argus Health
Merck

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