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Serving leading biopharmaceutical companies globally:

Baxter
Citi
Covington
McKesson
UBS
Julphar
Fuji
Fish and Richardson
Accenture
AstraZeneca

Generated: January 17, 2018

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.

The generic ingredient in PREZISTA is darunavir ethanolate. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.
Summary for PREZISTA
Drug patent expirations by year for PREZISTA
Medical Subject Heading (MeSH) Categories for PREZISTA

US Patents and Regulatory Information 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;ORAL 021976-003 Oct 21, 2008 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-005 Dec 18, 2008 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 PREZISTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-004 Dec 18, 2008 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-005 Dec 18, 2008 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 ➤ Subscribe ➤ Subscribe
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for PREZISTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 75 mg, 150 mg, 300 mg, 400 mg and 600 mg ➤ Subscribe 6/23/2010
➤ Subscribe Tablets 800 mg ➤ Subscribe 5/14/2013

International Patents for PREZISTA

Supplementary Protection Certificates for PREZISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0034 France ➤ Subscribe PRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
2017 00002 Denmark ➤ Subscribe 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
2016000103 Germany ➤ Subscribe PRODUCT 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
90034-3 Sweden ➤ Subscribe PRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
C/GB07/038 United Kingdom ➤ Subscribe PRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212
/2016 Austria ➤ Subscribe PRODUCT 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
2016040 Lithuania ➤ Subscribe PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
0861 Netherlands ➤ Subscribe PRODUCT 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
00283 Netherlands ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Medtronic
Julphar
Moodys
Chinese Patent Office
Daiichi Sankyo
Baxter
Deloitte

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