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Last Updated: May 22, 2024

~ Buy the DELSTRIGO (doravirine; lamivudine; tenofovir disoproxil fumarate) Drug Profile, 2024 PDF Report in the Report Store ~

DELSTRIGO Drug Patent Profile


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

Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-six patent family members in forty-five countries.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Delstrigo

Delstrigo was eligible for patent challenges on August 30, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2031. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for DELSTRIGO
International Patents:96
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 10
Formulation / Manufacturing:see details
Drug Prices: Drug price information for DELSTRIGO
What excipients (inactive ingredients) are in DELSTRIGO?DELSTRIGO excipients list
DailyMed Link:DELSTRIGO at DailyMed
Drug patent expirations by year for DELSTRIGO
Drug Prices for DELSTRIGO

See drug prices for DELSTRIGO

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

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

SponsorPhase
Liverpool School of Tropical MedicinePhase 4
Desmond Tutu Health FoundationPhase 4
University of LiverpoolPhase 4

See all DELSTRIGO clinical trials

Paragraph IV (Patent) Challenges for DELSTRIGO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DELSTRIGO Tablets doravirine; lamivudine; tenofovir disoproxil fumarate 100 mg/300 mg/ 300 mg 210807 1 2022-08-30

US Patents and Regulatory Information for DELSTRIGO

DELSTRIGO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DELSTRIGO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 DELSTRIGO

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED

FDA Regulatory Exclusivity protecting DELSTRIGO

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DELSTRIGO

When does loss-of-exclusivity occur for DELSTRIGO?

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

Argentina

Patent: 0859
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11235568
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012024691
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 94377
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12002744
Estimated Expiration: ⤷  Sign Up

China

Patent: 2971308
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 30126
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120503
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150427
Estimated Expiration: ⤷  Sign Up

Patent: 0161680
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16437
Estimated Expiration: ⤷  Sign Up

Patent: 18774
Estimated Expiration: ⤷  Sign Up

Patent: 19025
Estimated Expiration: ⤷  Sign Up

Patent: 19026
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000256
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 12012201
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4804
Estimated Expiration: ⤷  Sign Up

Patent: 1290976
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0190020
Estimated Expiration: ⤷  Sign Up

Patent: 0190021
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0156368
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 12002039
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 75471
Estimated Expiration: ⤷  Sign Up

Patent: 09121
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25336
Estimated Expiration: ⤷  Sign Up

Patent: 31785
Estimated Expiration: ⤷  Sign Up

Patent: 900021
Estimated Expiration: ⤷  Sign Up

Patent: 900022
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2030
Estimated Expiration: ⤷  Sign Up

Patent: 3334
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 81718
Estimated Expiration: ⤷  Sign Up

Patent: 86790
Estimated Expiration: ⤷  Sign Up

Patent: 13209405
Estimated Expiration: ⤷  Sign Up

Patent: 13510800
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 552902
Estimated Expiration: ⤷  Sign Up

Patent: 924034
Estimated Expiration: ⤷  Sign Up

Patent: 2019506
Estimated Expiration: ⤷  Sign Up

Patent: 2019507
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0114
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3979
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12011379
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 181
Estimated Expiration: ⤷  Sign Up

Patent: 570
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 170
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0980
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2670
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1200146
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 19018
Estimated Expiration: ⤷  Sign Up

Patent: 19019
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 130158
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 017
Estimated Expiration: ⤷  Sign Up

Patent: 505
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 4347
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1421861
Estimated Expiration: ⤷  Sign Up

Patent: 120128703
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 36295
Estimated Expiration: ⤷  Sign Up

Patent: 09636
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 58719
Estimated Expiration: ⤷  Sign Up

Patent: 1139409
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 12000455
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 8495
Estimated Expiration: ⤷  Sign Up

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 DELSTRIGO around the world.

Country Patent Number Title Estimated Expiration
Lithuania C2552902 ⤷  Sign Up
Norway 2019018 ⤷  Sign Up
New Zealand 602670 Non-nucleoside reverse transcriptase inhibitors ⤷  Sign Up
South Korea 20120128703 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS ⤷  Sign Up
Taiwan I458719 ⤷  Sign Up
Poland 2924034 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DELSTRIGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 2019C/005 Belgium ⤷  Sign Up PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2924034 SPC/GB19/024 United Kingdom ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122
2552902 LUC00113 Luxembourg ⤷  Sign Up PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
2552902 C201930026 Spain ⤷  Sign Up PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2924034 122019000042 Germany ⤷  Sign Up PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2924034 CR 2019 00024 Denmark ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
>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.