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Serving 500+ biopharmaceutical companies globally:

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Generated: July 24, 2017

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

Darunavir ethanolate has thirty-three patent family members in fourteen 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.

Summary for Generic Name: darunavir ethanolate

Tradenames:1
Patents:10
Applicants:1
NDAs:2
Drug Master File Entries: see list24
Suppliers / Packagers: see list5
Bulk Api Vendors: see list20
Clinical Trials: see list162
Patent Applications: see list46
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:darunavir ethanolate at DailyMed

Pharmacology for Ingredient: darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe75MGTABLET;ORAL
► Subscribe► Subscribe800MGTABLET;ORAL
► Subscribe► Subscribe600MGTABLET;ORAL
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
SUSPENSION;ORAL202895-001Dec 16, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNYesNo► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-006Nov 9, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: darunavir ethanolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-004Dec 18, 2008► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
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International Patent Family for Ingredient: darunavir ethanolate

Country Document Number Estimated Expiration
Japan2007291131► Subscribe
Australia722812► Subscribe
World Intellectual Property Organization (WIPO)9701349► Subscribe
Portugal2295052► Subscribe
Spain2328559► Subscribe
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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.

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Supplementary Protection Certificates for Tradename: DARUNAVIR ETHANOLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90034-3Sweden► SubscribePRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
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
C0034France► SubscribePRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Moodys
Argus Health
Covington
Medtronic
Cerilliant
McKinsey
Julphar
QuintilesIMS
Merck
Farmers Insurance

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.

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