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Last Updated: May 19, 2024

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SYMTUZA Drug Patent Profile


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Which patents cover Symtuza, and when can generic versions of Symtuza launch?

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

This drug has four hundred and eighty-five patent family members in fifty-one countries.

The generic ingredient in SYMTUZA is cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. 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; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Symtuza

Symtuza was eligible for patent challenges on November 5, 2019.

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 thirty 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 SYMTUZA
Drug Prices for SYMTUZA

See drug prices for SYMTUZA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYMTUZA
Generic Entry Date for SYMTUZA*:
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 SYMTUZA

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

SponsorPhase
East Carolina UniversityPhase 4
Chelsea and Westminster NHS Foundation TrustPhase 3
Imperial College LondonPhase 3

See all SYMTUZA clinical trials

Paragraph IV (Patent) Challenges for SYMTUZA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYMTUZA Tablets cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate 800 mg/150 mg/ 200 mg/10 mg 210455 1 2021-08-16

US Patents and Regulatory Information for SYMTUZA

SYMTUZA is protected by fifteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYMTUZA 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 SYMTUZA

Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods of treating HIV
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH = 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Prodrugs of phosphonate nucleotide analogues
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: TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

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

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y 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 SYMTUZA

International Patents for SYMTUZA

When does loss-of-exclusivity occur for SYMTUZA?

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 SYMTUZA around the world.

Country Patent Number Title Estimated Expiration
Japan 2002012591 METHOD FOR SYNTHESIZING BCH-189 RELATED COMPOUND AND COMPOSITION ⤷  Try a Trial
Norway 20210811 Modulatorer av farmakokinetikkegenskaper til terapeutika ⤷  Try a Trial
New Zealand 250842 RESOLUTION OF A RACEMIC MIXTURE OF NUCLEOSIDE ENANTIOMERS SUCH AS 2-HYDROXYMETHYL-5-(5-FLUOROCYTOSIN-1-YL)-1,3-OXATHIOLANE (FTC) ⤷  Try a Trial
Japan 2004504402 ⤷  Try a Trial
Taiwan 200909422 Modulators of pharmacokinetic properties of therapeutics ⤷  Try a Trial
China 1109108 ⤷  Try a Trial
Hungary E029843 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMTUZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 CA 2015 00060 Denmark ⤷  Try a Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487166 122016000104 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487162 C20170003 00221 Estonia ⤷  Try a Trial PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
1301519 PA2016009,C1301519 Lithuania ⤷  Try a Trial PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
2487166 380 3-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2049506 C02049506/01 Switzerland ⤷  Try a Trial PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013
1301519 CA 2016 00012 Denmark ⤷  Try a Trial PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.