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Generated: April 21, 2019

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Darunavir ethanolate - Generic Drug Details

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What are the generic 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.

Darunavir ethanolate has seventy patent family members in twenty-seven countries.

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-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
[(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
[14C]-Darunavir ethanolate
33O78XF0BW
635728-39-1
635728-49-3
AB2000167
ABP000914
AC-26777
AK341012
AKOS025149225
AS-35215
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
DarunavirEthanolate
HY-17041
KS-00000LFB
LS-186602
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
Prezista (TN)
Prezista;TMC114
QWSHKNICRJHQCY-VBTXLZOXSA-N
S1620
SC-94587
SCHEMBL562454
SW219052-1
UNII-33O78XF0BW
W-5737
Tentative approvals for DARUNAVIR ETHANOLATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial300MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial150MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial75MGTABLET;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 021976-006 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 ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-005 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 021976-001 Jun 23, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate 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 021976-001 Jun 23, 2006 DISCN Yes No ➤ 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 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 021976-005 Dec 18, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
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 021976-005 Dec 18, 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for darunavir ethanolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0810209 33/2007 Austria ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/06/380/001 - EU/1/06/380/008 20070212
2487162 284 1-2017 Slovakia ➤ Try a Free Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121
2487162 1790003-6 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
2487162 2016/063 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
0810209 CA 2007 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
0810209 C300283 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
2487162 CA 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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