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Last Updated: October 26, 2021

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Darunavir - Generic Drug Details

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What are the generic 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
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 209
Patent Applications: 6,761
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
FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n 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
⤷  Free Forever Trial⤷  Free Forever Trial800MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial600MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial400MGTABLET;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 021976-002 Feb 25, 2008 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Janssen Prods PREZISTA darunavir SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 TABLET;ORAL 021976-002 Feb 25, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 ⤷  Free Forever Trial ⤷  Free Forever 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 18/2020 Austria ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586 301045 Netherlands ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586 2020/021 Ireland ⤷  Free Forever 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 ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION 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:

AstraZeneca
Baxter
McKinsey
Medtronic
Merck
Colorcon

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