PREZISTA Drug Patent Profile

✉ Email this page to a colleague

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 21^st, 2017.

Try a Trial

Summary for PREZISTA

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	44
Patent Applications:	5,940
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PREZISTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZISTA
What excipients (inactive ingredients) are in PREZISTA?	PREZISTA excipients list
DailyMed Link:	PREZISTA at DailyMed

Drug patent expirations by year for PREZISTA

Recent Clinical Trials for PREZISTA

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

Sponsor	Phase
Frederick National Laboratory for Cancer Research	Phase 4
Geropharm	N/A
Wits Reproductive Health and HIV Institute	Phase 1

See all PREZISTA clinical trials

Pharmacology for PREZISTA

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PREZISTA

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ 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	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for PREZISTA

Subscribe to access the full database, or Try a Trial
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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Poland	173643		⤷ Try a Trial
Canada	2140929	HYDROXYETHYLAMINOSULFONAMIDES UTILES COMME INHIBITEURS DE LAPROTEASE RETROVIRALE (HYDROXYETHYLAMINO SULFONAMIDES USEFUL AS RETROVIRAL PROTEASEINHIBITORS)	⤷ Try a Trial
Netherlands	300283		⤷ Try a Trial
New Zealand	530169	Methods to mobilize progenitor/stem cells	⤷ Try a Trial
Japan	5101589		⤷ Try a Trial
Czech Republic	9401188		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PREZISTA

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0619813	CA 2009 00052	Denmark	⤷ Try a Trial
2487162	17C1002	France	⤷ Try a Trial	PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2487162	SPC/GB17/009	United Kingdom	⤷ Try a Trial	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/967 20141121
2371361	CA 2019 00044	Denmark	⤷ Try a Trial	PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731
2371361	301031	Netherlands	⤷ Try a Trial	PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
2487162	300861	Netherlands	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description