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Last Updated: March 29, 2024

PREZISTA Drug Patent 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. Ten 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

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Recent Clinical Trials for PREZISTA

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

SponsorPhase
Frederick National Laboratory for Cancer ResearchPhase 4
GeropharmN/A
University of Cape TownPhase 1

See all PREZISTA clinical trials

Paragraph IV (Patent) Challenges for PREZISTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREZISTA Tablets darunavir 800 mg 021976 1 2013-05-14
PREZISTA Tablets darunavir 600 mg 021976 4 2010-06-23

US Patents and Regulatory Information for PREZISTA

PREZISTA is protected by two US patents.

Patents protecting PREZISTA

Pseudopolymorphic forms of a HIV protease inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pseudopolymorphic forms of a HIV protease inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-004 Dec 18, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for PREZISTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Darunavir Mylan darunavir EMEA/H/C/004068
Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10⁶/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
Authorised yes no no 2017-01-03
Janssen-Cilag International NV Prezista darunavir EMEA/H/C/000707
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated.For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART) naïve.ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.
Authorised no no no 2007-02-11
KRKA, d.d., Novo mesto Darunavir Krka d.d. darunavir EMEA/H/C/004891
400mg and 800 mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).Darunavir Krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.
Withdrawn yes no no 2018-01-18
KRKA, d.d., Novo mesto Darunavir Krka darunavir EMEA/H/C/004273
400 and 800 mgDarunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.
Authorised yes no no 2018-01-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PREZISTA

See the table below for patents covering PREZISTA around the world.

Country Patent Number Title Estimated Expiration
Mexico PA04011427 FORMAS SEUDOPOLIMORFICAS DE UN INHIBIDOR DE PROTEASA DEL VIRUS DE INMUNODEFICIENCIA ADQUIRIDA. (PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR.) ⤷  Try a Trial
Spain 2362404 ⤷  Try a Trial
Germany 69332002 ⤷  Try a Trial
Finland 20012317 ⤷  Try a Trial
Japan 4864320 ⤷  Try a Trial
Denmark 0715618 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREZISTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0810209 CA 2007 00017 Denmark ⤷  Try a Trial PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
0810209 SZ 33/2007 Austria ⤷  Try a Trial PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE
0810209 0790034-3 Sweden ⤷  Try a Trial PRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
2487162 122016000103 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/967 20141119
0619813 10C0002 France ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR SOUS TOUTES SES FORMES, EN PARTICULIER SES SELS D'ADDITION AVEC UN ACIDE NON TOXIQUE OU SES COMPLEXES AVEC UN METAL; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
3150586 301045 Netherlands ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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