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Last Updated: June 3, 2023

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-one patent family members in forty-four 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:91
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 10
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in DELSTRIGO?DELSTRIGO excipients list
DailyMed Link:DELSTRIGO at DailyMed
Drug patent expirations by year 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 three FDA Regulatory Exclusivities.

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

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

EXPANDED INDICATION FOR PTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HX OF TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W RESISTANCE TO DORAVIRINE, LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  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
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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: ⤷  Try a Trial

Australia

Patent: 11235568
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012024691
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 94377
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12002744
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2971308
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 30126
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120503
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150427
Estimated Expiration: ⤷  Try a Trial

Patent: 0161680
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16437
Estimated Expiration: ⤷  Try a Trial

Patent: 18774
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 52902
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 012000256
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 12012201
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 4804
Estimated Expiration: ⤷  Try a Trial

Patent: 1290976
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 52902
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0156368
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 12002039
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 75471
Estimated Expiration: ⤷  Try a Trial

Patent: 09121
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25336
Estimated Expiration: ⤷  Try a Trial

Patent: 31785
Estimated Expiration: ⤷  Try a Trial

Patent: 900021
Estimated Expiration: ⤷  Try a Trial

Patent: 900022
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2030
Estimated Expiration: ⤷  Try a Trial

Patent: 3334
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 81718
Estimated Expiration: ⤷  Try a Trial

Patent: 86790
Estimated Expiration: ⤷  Try a Trial

Patent: 13209405
Estimated Expiration: ⤷  Try a Trial

Patent: 13510800
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 552902
Estimated Expiration: ⤷  Try a Trial

Patent: 924034
Estimated Expiration: ⤷  Try a Trial

Patent: 2019506
Estimated Expiration: ⤷  Try a Trial

Patent: 2019507
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0114
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3979
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 12011379
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 181
Estimated Expiration: ⤷  Try a Trial

Patent: 570
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 170
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0980
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2670
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1200146
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 19018
Estimated Expiration: ⤷  Try a Trial

Patent: 19019
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 130158
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 52902
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 52902
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 017
Estimated Expiration: ⤷  Try a Trial

Patent: 505
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 4347
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 52902
Estimated Expiration: ⤷  Try a Trial

Patent: 24034
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1421861
Estimated Expiration: ⤷  Try a Trial

Patent: 120128703
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 36295
Estimated Expiration: ⤷  Try a Trial

Patent: 09636
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 58719
Estimated Expiration: ⤷  Try a Trial

Patent: 1139409
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 12000455
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8495
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 DELSTRIGO around the world.

Country Patent Number Title Estimated Expiration
Poland 2552902 ⤷  Try a Trial
European Patent Office 3960163 COMPOSITIONS PHARMACEUTIQUES CONTENANT DE LA DORAVIRINE, DU FUMARATE DE T√ČNOFOVIR DISOPROXIL ET DE LA LAMIVUDINE (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE) ⤷  Try a Trial
Mexico 2018006773 COMPOSICIONES FARMACEUTICAS QUE CONTIENEN DORAVIRINA, TENOFOVIR DISOPROXIL FUMARATO Y LAMIVUDINA. (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE.) ⤷  Try a Trial
Lithuania C2924034 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DELSTRIGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 CR 2019 00024 Denmark ⤷  Try a Trial 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
2924034 SPC/GB19/024 United Kingdom ⤷  Try a Trial 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
2924034 2019C/005 Belgium ⤷  Try a Trial 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
2552902 122019000038 Germany ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Colorcon
McKesson
Medtronic
Moodys

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.