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.
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
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 |

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
Sponsor | Phase |
---|---|
Merck Sharp & Dohme Corp. | Phase 4 |
Chelsea and Westminster NHS Foundation Trust | Phase 4 |
Thomas Jefferson University | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for DELSTRIGO
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 |