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Last Updated: June 27, 2022

SYMTUZA Drug Patent Profile


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

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

This drug has four hundred and seventy-four patent family members in forty-nine 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 twenty-eight 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 Generic Entry Opportunity 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
Imperial College LondonPhase 3
Chelsea and Westminster NHS Foundation TrustPhase 3
Janssen Scientific Affairs, LLCPhase 4

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 seventeen US patents.

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

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

Compositions and methods of treating HIV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: 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

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Modulators of pharmacokinetic properties of therapeutics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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: 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 SYMTUZA around the world.

Country Patent Number Title Estimated Expiration
African Regional IP Organization (ARIPO) 3250 Tablets for combination therapy See Plans and Pricing
Japan 2015078241 治療薬の薬物動態特性の調節 (ADJUSTMENT OF PHARMACOKINETICS OF CURATIVE MEDICINE) See Plans and Pricing
Portugal 2336134 See Plans and Pricing
Japan 4891435 See Plans and Pricing
South Korea 100749160 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMTUZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 91073 Luxembourg See Plans and Pricing 91073, EXPIRES: 20160131
3150586 C202030023 Spain See Plans and Pricing PRODUCT NAME: COBICISTAT O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, DARUNAVIR O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR ETANOLATO DE DARUNAVIR, Y EMTRICITABINA O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1225; DATE OF FIRST AUTHORISATION IN EEA: 20170921
2487163 SPC/GB17/010 United Kingdom See Plans and Pricing PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715
2487166 59/2016 Austria See Plans and Pricing PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
3150586 PA2020508 Lithuania See Plans and Pricing PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Medtronic
Baxter
Colorcon
McKesson

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.