DELSTRIGO Drug Patent Profile
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Which patents cover Delstrigo, 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-seven 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: | 97 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 11 |
| Drug Prices: | Drug price information for DELSTRIGO |
| What excipients (inactive ingredients) are in DELSTRIGO? | DELSTRIGO excipients list |
| DailyMed Link: | DELSTRIGO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DELSTRIGO
*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 |
|---|---|
| Africa Health Research Institute | Phase 3 |
| University of Liverpool | Phase 4 |
| Liverpool School of Tropical Medicine | Phase 4 |
Pharmacology 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 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
Patent: DERIVADOS 1,2,4 TRIAZOLO-PIRIDINICOS INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA, UTILES PARA TRATAR INFECCIONES POR VIH Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN.
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 11235568
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012024691
Patent: composto, e, composição farmacêutica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 94377
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLEOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12002744
Patent: Compuesto inhibidor no nucleosídico de la transcriptasa inversa derivado de 3-(hidrocarbiloxi aromático y alifático opcionalmente sustituido)-1-[(5-oxo-4,5-dihidro-1h-1,2,4-triazol-3-il)metil])-piridin-2(ih)-ona; composición farmacéutica que lo comprende útil en la profilaxis y tratamiento de la infección por vih y sida.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2971308
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 30126
Patent: Inhibidores no nucleosídicos de la transcriptasa inversa
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120503
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
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
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 12012201
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 4804
Patent: НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ, КОМПОЗИЦИИ, ИХ СОДЕРЖАЩИЕ, И ИХ ПРИМЕНЕНИЕ (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS, COMPOSITIONS COMPRISING THEM, AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 1290976
Patent: НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 52902
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 24034
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN INHIBITEUR NON NUCLÉOSIDIQUE DE TRANSCRIPTASE INVERSE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0190020
Estimated Expiration: ⤷ Sign Up
Patent: 0190021
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0156368
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Honduras
Patent: 12002039
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 75471
Patent: 非核苷類逆轉錄酶抑制劑 (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 09121
Patent: 包含非核苷逆轉錄酶抑制劑的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
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
Patent: מעכבי רוורס טרנסקיפטז לא נאוקלוזידי (Non-nucleoside reverse transcriptase inhibitors)
Estimated Expiration: ⤷ Sign Up
Patent: 3334
Patent: תרכובות 3-(הידרוקרבילאוקסי ארומטי ואליפטי המותמר אופציונאלית)-1-[(5-אוקסו-5,4-דיהידרו-1h-4,2,1-טריאזול-3-איל)מתיל]-פירידין-2-(1h)- און, הרכב רוקחי המכיל אותן ושימוש בהן (3-(optionally substituted aromatic and aliphatic hydrocarbyloxy)-1-[(5-oxo-4,5-dihydro-1h-1,2,4-triazol-3-yl)methyl]-pyridin-2(1h)-one compounds, pharmaceutical composition comprising same, and use thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 81718
Estimated Expiration: ⤷ Sign Up
Patent: 86790
Estimated Expiration: ⤷ Sign Up
Patent: 13209405
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
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
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12011379
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 181
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 570
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 170
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0980
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2670
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1200146
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 19018
Estimated Expiration: ⤷ Sign Up
Patent: 19019
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 130158
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
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
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 505
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 4347
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
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
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
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
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 12000455
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 8495
Patent: НЕНУКЛЕОЗИДНІ ІНГІБІТОРИ ЗВОРОТНОЇ ТРАНСКРИПТАЗИ (REVERSE TRANSCRIPTASE NUCLEOSIDE INHIBITORS)
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 | 2924034 | ⤷ Sign Up | |
| Argentina | 080859 | DERIVADOS 1,2,4 TRIAZOLO-PIRIDINICOS INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA, UTILES PARA TRATAR INFECCIONES POR VIH Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN. | ⤷ Sign Up |
| South Korea | 20120128703 | NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS | ⤷ Sign Up |
| South Korea | 101421861 | ⤷ Sign Up | |
| Serbia | 55505 | FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR) | ⤷ Sign Up |
| Japan | 5886790 | ⤷ 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 | C02924034/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DORAVIRIN, LAMIVUDIN UND TENOFOVIRDISOPROXIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67066 17.12.2019 |
| 2924034 | C201930027 | Spain | ⤷ Sign Up | PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; 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 |
| 2552902 | 300980 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126 |
| 2552902 | C20190024 00304 | Estonia | ⤷ Sign Up | PRODUCT NAME: DORAVIRIIN;REG NO/DATE: EU/1/18/1332 27.11.2018 |
| 2924034 | 2019/021 | Ireland | ⤷ Sign Up | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122 |
| >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.
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