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Last Updated: April 14, 2021

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Darunavir - Generic Drug Details

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What are the generic drug sources for darunavir and what is the scope of freedom to operate?

Darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods and Teva Pharms Usa, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-five drug master file entries for darunavir. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for darunavir
International Patents:48
US Patents:2
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 25
Suppliers / Packagers: 2
Bulk Api Vendors: 77
Clinical Trials: 209
Patent Applications: 6,588
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in darunavir?darunavir excipients list
DailyMed Link:darunavir at DailyMed
Recent Clinical Trials for darunavir

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

SponsorPhase
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaPhase 4
Mansoura UniversityPhase 3
Mahidol UniversityPhase 4

See all darunavir clinical trials

Generic filers with tentative approvals for DARUNAVIR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial75MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DARUNAVIR
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 darunavir

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 TABLET;ORAL 021976-005 Dec 18, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-004 Dec 18, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 darunavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-004 Dec 18, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for darunavir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3150586 PA2020508 Lithuania   Start Trial PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162 93352 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2487162 PA2016040 Lithuania   Start Trial PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
0810209 33/2007 Austria   Start Trial PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/06/380/001 - EU/1/06/380/008 20070212
2487162 132017000002735 Italy   Start Trial PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121
3150586 2090020-5 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEBTABLE SALT OR SOLVATE THEREOF; 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:

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Boehringer Ingelheim

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