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Last Updated: January 27, 2021

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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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine; lamivudine; tenofovir disoproxil fumarate has seventy-nine patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for doravirine; lamivudine; tenofovir disoproxil fumarate
International Patents:79
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 6
DailyMed Link:doravirine; lamivudine; tenofovir disoproxil fumarate at DailyMed
Recent Clinical Trials for doravirine; lamivudine; tenofovir disoproxil fumarate

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

SponsorPhase
Willem Daniel Francois VenterPhase 3
Dr. Josep MallolasPhase 4
David Garcia CincaPhase 4

See all doravirine; lamivudine; tenofovir disoproxil fumarate clinical trials

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   Start Trial   Start Trial Y Y   Start Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2552902 122019000038 Germany   Start Trial
2924034 2019/021 Ireland   Start Trial 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
2552902 2019C/004 Belgium   Start Trial PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2552902 PA2019506 Lithuania   Start Trial PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 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.