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Last Updated: June 13, 2021

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PREZISTA Drug Profile


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Which patents cover Prezista, and what generic alternatives are available?

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

This drug has forty-eight patent family members in twenty-five countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Prezista

A generic version of PREZISTA was approved as darunavir by TEVA PHARMS USA on November 21st, 2017.

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Drug patent expirations by year for PREZISTA
Drug Prices for PREZISTA

See drug prices for PREZISTA

Recent Clinical Trials for PREZISTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Frederick National Laboratory for Cancer ResearchPhase 4
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
GeropharmN/A

See all PREZISTA clinical trials

Paragraph IV (Patent) Challenges for PREZISTA
Tradename Dosage Ingredient NDA Submissiondate
PREZISTA TABLET;ORAL darunavir 021976 2013-05-14
PREZISTA TABLET;ORAL darunavir 021976 2010-06-23

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 SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-004 Dec 18, 2008 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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 PREZISTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-005 Dec 18, 2008   Get Started Free   Get Started Free
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-005 Dec 18, 2008   Get Started Free   Get Started Free
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011   Get Started Free   Get Started Free
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PREZISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411918 C 2012 019 Romania   Get Started Free PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
1411918 PA2012011,C1411918 Lithuania   Get Started Free PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
0810209 SPC024/2007 Ireland   Get Started Free SPC024/2007: 20081105, EXPIRES: 20180823
3150586 CA 2020 00021 Denmark   Get Started Free PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Merck
Boehringer Ingelheim
AstraZeneca
Dow

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