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
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 |

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
Sponsor | Phase |
---|---|
Liverpool School of Tropical Medicine | Phase 4 |
Desmond Tutu Health Foundation | Phase 4 |
University of Liverpool | Phase 4 |
Pharmacology for DELSTRIGO
Anatomical Therapeutic Chemical (ATC) Classes for DELSTRIGO
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 TÉNOFOVIR 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 |