.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Covington
Julphar
US Department of Justice
Fish and Richardson
US Army
Chubb
McKinsey
Baxter
Cerilliant

Generated: December 15, 2017

DrugPatentWatch Database Preview

Darunavir ethanolate - Generic Drug Details

« Back to Dashboard

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 one branded drug marketed by Janssen Prods and is included in two NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Darunavir ethanolate has forty patent family members in fourteen countries and nine supplementary protection certificates in eight countries.

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

Medical Subject Heading (MeSH) Categories for darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Strength Dosage Form
u► Subscribe75MGTABLET;ORAL
u► Subscribe800MGTABLET;ORAL
u► Subscribe600MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-006Nov 9, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-004Dec 18, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-004Dec 18, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-006Nov 9, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-005Dec 18, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-004Dec 18, 2008RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-005Dec 18, 2008RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: darunavir ethanolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-005Dec 18, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateSUSPENSION;ORAL202895-001Dec 16, 2011► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-006Nov 9, 2012► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-006Nov 9, 2012► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-001Jun 23, 2006► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-002Feb 25, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-001Jun 23, 2006► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateSUSPENSION;ORAL202895-001Dec 16, 2011► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: darunavir ethanolate

Country Document Number Estimated Expiration
Denmark1284140► Subscribe
Denmark2295052► Subscribe
European Patent Office2130534► Subscribe
Germany69637976► Subscribe
Portugal2295052► Subscribe
Japan2012111775► Subscribe
European Patent Office1293207► Subscribe
European Patent Office2295052► Subscribe
Portugal1284140► Subscribe
Japan5364871► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: DARUNAVIR ETHANOLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2016Austria► SubscribePRODUCT 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
C0034France► SubscribePRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
2016000103Germany► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
00283Netherlands► SubscribePRODUCT 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
2016040Lithuania► SubscribePRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
0861Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
2017 00002Denmark► SubscribePRODUCT 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
C/GB07/038United Kingdom► SubscribePRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212
90034-3Sweden► SubscribePRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Merck
Farmers Insurance
Novartis
Cantor Fitzgerald
Colorcon
AstraZeneca
Harvard Business School
Accenture
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot