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Last Updated: May 26, 2022

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-four 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. One supplier is 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 ten 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 Generic Entry Opportunity 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
Janssen Scientific Affairs, LLCPhase 2/Phase 3
Stanford UniversityPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pseudopolymorphic forms of a HIV protease inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of pharmacokinetic properties of therapeutics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 See Plans and Pricing See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 See Plans and Pricing See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 See Plans and Pricing See Plans and Pricing
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Patent: 50
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 5369
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09242451
Estimated Expiration: See Plans and Pricing

Patent: 10210598
Estimated Expiration: See Plans and Pricing

Patent: 14221210
Estimated Expiration: See Plans and Pricing

Patent: 15200637
Estimated Expiration: See Plans and Pricing

Patent: 16250470
Estimated Expiration: See Plans and Pricing

Patent: 17201473
Estimated Expiration: See Plans and Pricing

Patent: 18267573
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0911871
Estimated Expiration: See Plans and Pricing

Patent: 1008664
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20856
Estimated Expiration: See Plans and Pricing

Patent: 50521
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11001885
Estimated Expiration: See Plans and Pricing

China

Patent: 2123700
Estimated Expiration: See Plans and Pricing

Patent: 2307573
Estimated Expiration: See Plans and Pricing

Patent: 3479584
Estimated Expiration: See Plans and Pricing

Patent: 4940937
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 21225
Estimated Expiration: See Plans and Pricing

Patent: 00187
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151009
Estimated Expiration: See Plans and Pricing

Patent: 0151357
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16852
Estimated Expiration: See Plans and Pricing

Patent: 17067
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010636
Estimated Expiration: See Plans and Pricing

Patent: 11011307
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: See Plans and Pricing

Patent: 2950
Estimated Expiration: See Plans and Pricing

Patent: 0123
Estimated Expiration: See Plans and Pricing

Patent: 1071173
Estimated Expiration: See Plans and Pricing

Patent: 1190125
Estimated Expiration: See Plans and Pricing

Patent: 1491658
Estimated Expiration: See Plans and Pricing

Patent: 1591353
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Patent: 06032
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 53670
Estimated Expiration: See Plans and Pricing

Patent: 64737
Estimated Expiration: See Plans and Pricing

Patent: 15679
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25822
Estimated Expiration: See Plans and Pricing

Patent: 26380
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8614
Estimated Expiration: See Plans and Pricing

Patent: 4227
Estimated Expiration: See Plans and Pricing

Patent: 7417
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11242
Estimated Expiration: See Plans and Pricing

Patent: 22213
Estimated Expiration: See Plans and Pricing

Patent: 11927
Estimated Expiration: See Plans and Pricing

Patent: 25171
Estimated Expiration: See Plans and Pricing

Patent: 11522790
Estimated Expiration: See Plans and Pricing

Patent: 12517432
Estimated Expiration: See Plans and Pricing

Patent: 14012741
Estimated Expiration: See Plans and Pricing

Patent: 14221845
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2377
Estimated Expiration: See Plans and Pricing

Patent: 10011963
Estimated Expiration: See Plans and Pricing

Patent: 11008289
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8978
Estimated Expiration: See Plans and Pricing

Patent: 4214
Estimated Expiration: See Plans and Pricing

Peru

Patent: 110994
Estimated Expiration: See Plans and Pricing

Poland

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500266
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3544
Estimated Expiration: See Plans and Pricing

Patent: 0618
Estimated Expiration: See Plans and Pricing

Patent: 14007744
Estimated Expiration: See Plans and Pricing

Patent: 201609006W
Estimated Expiration: See Plans and Pricing

Patent: 201706215U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008007
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1645759
Estimated Expiration: See Plans and Pricing

Patent: 1659971
Estimated Expiration: See Plans and Pricing

Patent: 1738325
Estimated Expiration: See Plans and Pricing

Patent: 1784647
Estimated Expiration: See Plans and Pricing

Patent: 110015581
Estimated Expiration: See Plans and Pricing

Patent: 110122729
Estimated Expiration: See Plans and Pricing

Patent: 160093100
Estimated Expiration: See Plans and Pricing

Patent: 160114728
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48886
Estimated Expiration: See Plans and Pricing

Patent: 53897
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44367
Estimated Expiration: See Plans and Pricing

Patent: 1040142
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1193
Estimated Expiration: See Plans and Pricing

Patent: 3224
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 424
Estimated Expiration: See Plans and Pricing

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
South Korea 101636221 See Plans and Pricing
Japan 4864320 See Plans and Pricing
China 104940937 The use of solid carrier particles to improve the processability of a pharmaceutical agent See Plans and Pricing
Luxembourg C00156 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREZCOBIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 60/2016 Austria See Plans and Pricing PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2487166 PA2016038 Lithuania See Plans and Pricing PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163 122016000120 Germany See Plans and Pricing PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
0810209 2007/024 Ireland See Plans and Pricing
>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.