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Last Updated: November 22, 2024

Doravirine; lamivudine; tenofovir disoproxil fumarate - Generic Drug Details


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What are the generic drug sources for doravirine; lamivudine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Doravirine; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine; lamivudine; tenofovir disoproxil fumarate has ninety-seven patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for doravirine; lamivudine; tenofovir disoproxil fumarate
International Patents:97
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 13
DailyMed Link:doravirine; lamivudine; tenofovir disoproxil fumarate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for doravirine; lamivudine; tenofovir disoproxil fumarate
Generic Entry Date for doravirine; lamivudine; tenofovir disoproxil fumarate*:
Constraining patent/regulatory exclusivity:
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 doravirine; lamivudine; tenofovir disoproxil fumarate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Merck Sharp & Dohme LLCPhase 3
Prism Health North TexasPhase 3

See all doravirine; lamivudine; tenofovir disoproxil fumarate clinical trials

Paragraph IV (Patent) Challenges for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
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 doravirine; lamivudine; tenofovir disoproxil fumarate

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 ⤷  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 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 doravirine; lamivudine; tenofovir disoproxil fumarate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 201290976 НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ ⤷  Sign Up
Israel 222030 מעכבי רוורס טרנסקיפטז לא נאוקלוזידי (Non-nucleoside reverse transcriptase inhibitors) ⤷  Sign Up
European Patent Office 3383397 COMPOSITIONS PHARMACEUTIQUES CONTENANT DE LA DORAVIRINE, DU FUMARATE DE TÉNOFOVIR DISOPROXIL ET DE LA LAMIVUDINE (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 2019C/005 Belgium ⤷  Sign Up 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
2924034 C20190025 00305 Estonia ⤷  Sign Up PRODUCT NAME: DORAVIRIIN/LAMIVUDIIN/TENOFOVIIRDISOPROKSIIL;REG NO/DATE: EU/1/18/1333 26.11.2018
2552902 CR 2019 00025 Denmark ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
>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.