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Last Updated: November 14, 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 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-one patent family members in twenty-seven countries.

There are twenty-five drug master file entries for darunavir ethanolate. Three suppliers are listed for this compound.

Recent Litigation for darunavir ethanolate

Identify potential future generic entrants

District Court Litigation
Case NameDate
JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC2018-12-26
Genzyme Corporation v. Fresenius Kabi USA, LLC2018-12-06
Genzyme Corporation v. Gland Pharma Limited2018-07-19

See all darunavir ethanolate litigation

PTAB Litigation
PetitionerDate
Lupin Limited2015-04-09

See all darunavir ethanolate litigation

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
Paragraph IV (Patent) Challenges for DARUNAVIR ETHANOLATE
Tradename Dosage Ingredient NDA Submissiondate
PREZISTA TABLET;ORAL darunavir ethanolate 021976 2010-06-23

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 021976-003 Oct 21, 2008 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa DARUNAVIR ETHANOLATE darunavir ethanolate TABLET;ORAL 202118-001 Nov 21, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate 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 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   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for darunavir ethanolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0810209 CA 2007 00017 Denmark   Start Trial PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
2487162 17C1002 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2487162 PA2016040 Lithuania   Start Trial PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
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
2487162 1790003-6 Sweden   Start 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
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 SZ 33/2007 Austria   Start Trial PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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