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Last Updated: December 7, 2022

Doravirine - Generic Drug Details


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What are the generic sources for doravirine and what is the scope of patent protection?

Doravirine is the generic ingredient in two branded drugs marketed by Msd Merck Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine has sixty-nine patent family members in forty-three countries.

Two suppliers are listed for this compound.

Summary for doravirine
International Patents:69
US Patents:3
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 42
Patent Applications: 550
Drug Prices: Drug price trends for doravirine
What excipients (inactive ingredients) are in doravirine?doravirine excipients list
DailyMed Link:doravirine at DailyMed
Drug Prices for doravirine

See drug prices for doravirine

Recent Clinical Trials for doravirine

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

SponsorPhase
Fundacion Clinic per a la Recerca BiomédicaPhase 4
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Prism Health North TexasPhase 3

See all doravirine clinical trials

US Patents and Regulatory Information for doravirine

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 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 Y Y See Plans and Pricing
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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

EU/EMA Drug Approvals for doravirine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Pifeltro doravirine EMEA/H/C/004747
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
Authorised no no no 2018-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for doravirine

Country Patent Number Title Estimated Expiration
Ukraine 108495 НЕНУКЛЕОЗИДНІ ІНГІБІТОРИ ЗВОРОТНОЇ ТРАНСКРИПТАЗИ (REVERSE TRANSCRIPTASE NUCLEOSIDE INHIBITORS) See Plans and Pricing
Luxembourg C00114 See Plans and Pricing
Lithuania PA2019507 See Plans and Pricing
Morocco 34170 INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for doravirine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2552902 C20190024 00304 Estonia See Plans and Pricing PRODUCT NAME: DORAVIRIIN;REG NO/DATE: EU/1/18/1332 27.11.2018
2552902 2019019 Norway See Plans and Pricing PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1332/001-2 20181213
2552902 122019000038 Germany See Plans and Pricing
2924034 LUC00114 Luxembourg See Plans and Pricing PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND 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.