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Last Updated: June 29, 2022

Doravirine - Generic Drug Details


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What are the generic drug sources for doravirine and what is the scope of freedom to operate?

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.

One supplier is listed for this compound.

Summary for doravirine
International Patents:69
US Patents:3
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 47
Clinical Trials: 39
Patent Applications: 457
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
University of California, Los AngelesEarly Phase 1
Merck Sharp & Dohme Corp.Early Phase 1
Chelsea and Westminster NHS Foundation TrustPhase 4

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 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 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

Supplementary Protection Certificates for doravirine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
2924034 C201930027 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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