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Last Updated: June 3, 2023

PREZCOBIX Drug Patent Profile


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When do Prezcobix patents expire, and when can generic versions of Prezcobix launch?

Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty-three patent family members in thirty-nine countries.

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

DrugPatentWatch® Generic Entry Outlook for Prezcobix

Prezcobix was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PREZCOBIX
Drug Prices for PREZCOBIX

See drug prices for PREZCOBIX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PREZCOBIX
Generic Entry Date for PREZCOBIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREZCOBIX

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

SponsorPhase
Janssen Pharmaceutical K.K.Phase 4
Stanford UniversityPhase 2/Phase 3
University of Colorado, DenverPhase 2/Phase 3

See all PREZCOBIX clinical trials

Paragraph IV (Patent) Challenges for PREZCOBIX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREZCOBIX Tablets cobicistat; darunavir 800 mg/150 mg 205395 1 2020-07-24

US Patents and Regulatory Information for PREZCOBIX

PREZCOBIX is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PREZCOBIX is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PREZCOBIX

Use of solid carrier particles to improve the processability of a pharmaceutical agent
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

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

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 PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 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 PREZCOBIX

EU/EMA Drug Approvals for PREZCOBIX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V. Rezolsta darunavir, cobicistat EMEA/H/C/002819
Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.
Authorised no no no 2014-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PREZCOBIX

When does loss-of-exclusivity occur for PREZCOBIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 89
Estimated Expiration: ⤷  Try a Trial

Patent: 50
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 5369
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 09242451
Estimated Expiration: ⤷  Try a Trial

Patent: 10210598
Estimated Expiration: ⤷  Try a Trial

Patent: 14221210
Estimated Expiration: ⤷  Try a Trial

Patent: 15200637
Estimated Expiration: ⤷  Try a Trial

Patent: 16250470
Estimated Expiration: ⤷  Try a Trial

Patent: 17201473
Estimated Expiration: ⤷  Try a Trial

Patent: 18267573
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0911871
Estimated Expiration: ⤷  Try a Trial

Patent: 1008664
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 20856
Estimated Expiration: ⤷  Try a Trial

Patent: 50521
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11001885
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2123700
Estimated Expiration: ⤷  Try a Trial

Patent: 2307573
Estimated Expiration: ⤷  Try a Trial

Patent: 3479584
Estimated Expiration: ⤷  Try a Trial

Patent: 4940937
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 21225
Estimated Expiration: ⤷  Try a Trial

Patent: 00187
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0151009
Estimated Expiration: ⤷  Try a Trial

Patent: 0151357
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16852
Estimated Expiration: ⤷  Try a Trial

Patent: 17067
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010636
Estimated Expiration: ⤷  Try a Trial

Patent: 11011307
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: ⤷  Try a Trial

Patent: 2950
Estimated Expiration: ⤷  Try a Trial

Patent: 0123
Estimated Expiration: ⤷  Try a Trial

Patent: 1071173
Estimated Expiration: ⤷  Try a Trial

Patent: 1190125
Estimated Expiration: ⤷  Try a Trial

Patent: 1491658
Estimated Expiration: ⤷  Try a Trial

Patent: 1591353
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Patent: 06032
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 53670
Estimated Expiration: ⤷  Try a Trial

Patent: 64737
Estimated Expiration: ⤷  Try a Trial

Patent: 15679
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25822
Estimated Expiration: ⤷  Try a Trial

Patent: 26380
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8614
Estimated Expiration: ⤷  Try a Trial

Patent: 4227
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11242
Estimated Expiration: ⤷  Try a Trial

Patent: 22213
Estimated Expiration: ⤷  Try a Trial

Patent: 11927
Estimated Expiration: ⤷  Try a Trial

Patent: 25171
Estimated Expiration: ⤷  Try a Trial

Patent: 11522790
Estimated Expiration: ⤷  Try a Trial

Patent: 12517432
Estimated Expiration: ⤷  Try a Trial

Patent: 14012741
Estimated Expiration: ⤷  Try a Trial

Patent: 14221845
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2377
Estimated Expiration: ⤷  Try a Trial

Patent: 10011963
Estimated Expiration: ⤷  Try a Trial

Patent: 11008289
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8978
Estimated Expiration: ⤷  Try a Trial

Patent: 4214
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 110994
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01500266
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3544
Estimated Expiration: ⤷  Try a Trial

Patent: 0618
Estimated Expiration: ⤷  Try a Trial

Patent: 14007744
Estimated Expiration: ⤷  Try a Trial

Patent: 201609006W
Estimated Expiration: ⤷  Try a Trial

Patent: 201706215U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1008007
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1645759
Estimated Expiration: ⤷  Try a Trial

Patent: 1659971
Estimated Expiration: ⤷  Try a Trial

Patent: 1738325
Estimated Expiration: ⤷  Try a Trial

Patent: 1784647
Estimated Expiration: ⤷  Try a Trial

Patent: 110015581
Estimated Expiration: ⤷  Try a Trial

Patent: 110122729
Estimated Expiration: ⤷  Try a Trial

Patent: 160093100
Estimated Expiration: ⤷  Try a Trial

Patent: 160114728
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 48886
Estimated Expiration: ⤷  Try a Trial

Patent: 53897
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44367
Estimated Expiration: ⤷  Try a Trial

Patent: 1040142
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 1193
Estimated Expiration: ⤷  Try a Trial

Patent: 3224
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 424
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREZCOBIX around the world.

Country Patent Number Title Estimated Expiration
Slovenia 2767539 ⤷  Try a Trial
Croatia P20161476 ⤷  Try a Trial
Australia 4828199 ⤷  Try a Trial
Australia 2008218186 Modulators of pharmacokinetic properties of therapeutics ⤷  Try a Trial
Montenegro 02258 MODULATORI FARMAKOKINETIČKIH SVOJSTAVA TERAPEUTIKA (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) ⤷  Try a Trial
Cyprus 1116852 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREZCOBIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 CA 2017 00003 Denmark ⤷  Try a Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715
2049506 1590060-8 Sweden ⤷  Try a Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
2487166 2016/061 Ireland ⤷  Try a Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2049506 15C0078 France ⤷  Try a Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506 300780 Netherlands ⤷  Try a Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506 122015000092 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
McKinsey
McKesson
Dow
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.