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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Argus Health
McKesson
Daiichi Sankyo
Merck
Harvard Business School
Mallinckrodt
Dow
Boehringer Ingelheim

Generated: November 20, 2017

DrugPatentWatch Database Preview

PREZISTA Drug Profile

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Which patents cover Prezista, and when can generic versions of Prezista launch?

Prezista is a drug marketed by Janssen Prods and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has forty patent family members in fourteen countries and nine supplementary protection certificates in eight countries.

The generic ingredient in PREZISTA is darunavir ethanolate. There are twenty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.

Medical Subject Heading (MeSH) Categories for PREZISTA

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;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008DISCNYesNo► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-006Nov 9, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXYesNo► Subscribe► Subscribe► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-006Nov 9, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNYesNo► Subscribe► SubscribeY► Subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for PREZISTA

Drugname Dosage Strength RLD Submissiondate
darunavir ethanolateTablets75 mg, 150 mg, 300 mg, 400 mg and 600 mgPrezistas6/23/2010
darunavir ethanolateTablets800 mgPrezista5/14/2013

International Patent Family for Tradename: PREZISTA

Country Document Number Estimated Expiration
European Patent Office2295052► Subscribe
Canada2224738► Subscribe
European Patent Office1284140► Subscribe
Denmark2295052► Subscribe
Australia6342096► Subscribe
Hong Kong1016088► Subscribe
JapanH11508884► Subscribe
World Intellectual Property Organization (WIPO)9701349► Subscribe
Spain2328559► Subscribe
European Patent Office1273298► 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: PREZISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016040Lithuania► SubscribePRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; 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
/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
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
C/GB07/038United Kingdom► SubscribePRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212
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
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
90034-3Sweden► SubscribePRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
C0034France► SubscribePRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
AstraZeneca
Julphar
Healthtrust
Express Scripts
Harvard Business School
Citi
Moodys
Deloitte
Merck

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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