Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Colorcon
Baxter
McKinsey
McKesson

Last Updated: May 21, 2022

DELSTRIGO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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.

This drug has ninety 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 will be eligible for patent challenges on August 30, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

Summary for DELSTRIGO
International Patents:90
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 8
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 Generic Entry Opportunity 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
Merck Sharp & Dohme Corp.Phase 4
Chelsea and Westminster NHS Foundation TrustPhase 4
Thomas Jefferson UniversityPhase 1

See all DELSTRIGO clinical trials

US Patents and Regulatory Information for DELSTRIGO

DELSTRIGO is protected by five US patents and two FDA Regulatory Exclusivities.

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

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Non-nucleoside reverse transcriptase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: 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
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

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: See Plans and Pricing

Australia

Patent: 11235568
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012024691
Estimated Expiration: See Plans and Pricing

Canada

Patent: 94377
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002744
Estimated Expiration: See Plans and Pricing

China

Patent: 2971308
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30126
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120503
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150427
Estimated Expiration: See Plans and Pricing

Patent: 0161680
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16437
Estimated Expiration: See Plans and Pricing

Patent: 18774
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 52902
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 012000256
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012201
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4804
Estimated Expiration: See Plans and Pricing

Patent: 1290976
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 52902
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0156368
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 12002039
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 75471
Estimated Expiration: See Plans and Pricing

Patent: 09121
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25336
Estimated Expiration: See Plans and Pricing

Patent: 31785
Estimated Expiration: See Plans and Pricing

Patent: 900021
Estimated Expiration: See Plans and Pricing

Patent: 900022
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2030
Estimated Expiration: See Plans and Pricing

Patent: 3334
Estimated Expiration: See Plans and Pricing

Japan

Patent: 81718
Estimated Expiration: See Plans and Pricing

Patent: 86790
Estimated Expiration: See Plans and Pricing

Patent: 13209405
Estimated Expiration: See Plans and Pricing

Patent: 13510800
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 552902
Estimated Expiration: See Plans and Pricing

Patent: 924034
Estimated Expiration: See Plans and Pricing

Patent: 2019506
Estimated Expiration: See Plans and Pricing

Patent: 2019507
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0114
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3979
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12011379
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 181
Estimated Expiration: See Plans and Pricing

Patent: 570
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 170
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0980
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2670
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1200146
Estimated Expiration: See Plans and Pricing

Norway

Patent: 19018
Estimated Expiration: See Plans and Pricing

Patent: 19019
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130158
Estimated Expiration: See Plans and Pricing

Poland

Patent: 52902
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 52902
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 017
Estimated Expiration: See Plans and Pricing

Patent: 505
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 4347
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 52902
Estimated Expiration: See Plans and Pricing

Patent: 24034
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1421861
Estimated Expiration: See Plans and Pricing

Patent: 120128703
Estimated Expiration: See Plans and Pricing

Spain

Patent: 36295
Estimated Expiration: See Plans and Pricing

Patent: 09636
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 58719
Estimated Expiration: See Plans and Pricing

Patent: 1139409
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000455
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8495
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 DELSTRIGO around the world.

Country Patent Number Title Estimated Expiration
New Zealand 602670 Non-nucleoside reverse transcriptase inhibitors See Plans and Pricing
Spain 2536295 See Plans and Pricing
Peru 20130158 INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017095761 See Plans and Pricing
>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 See Plans and Pricing 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
2552902 C20190024 00304 Estonia See Plans and Pricing PRODUCT NAME: DORAVIRIIN;REG NO/DATE: EU/1/18/1332 27.11.2018
2552902 LUC00113 Luxembourg See Plans and Pricing PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
2924034 122019000042 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.