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
Summary for PREZCOBIX
International Patents: | 334 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 4 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PREZCOBIX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREZCOBIX |
What excipients (inactive ingredients) are in PREZCOBIX? | PREZCOBIX excipients list |
DailyMed Link: | PREZCOBIX at DailyMed |


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
Sponsor | Phase |
---|---|
Janssen Pharmaceutical K.K. | Phase 4 |
Janssen Scientific Affairs, LLC | Phase 2/Phase 3 |
Stanford University | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for PREZCOBIX
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 |