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Last Updated: April 28, 2024

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 seventy-three patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for doravirine

International Patents:	73
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	49
Patent Applications:	482
Drug Prices:	Drug price trends for doravirine
What excipients (inactive ingredients) are in doravirine?	doravirine excipients list
DailyMed Link:	doravirine at DailyMed

See drug prices for doravirine

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for doravirine

Generic Entry Date for doravirine^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4
Merck Sharp & Dohme LLC	Phase 4
Radboud University Medical Center	Phase 4

See all doravirine clinical trials

Pharmacology for doravirine

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for doravirine

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for doravirine

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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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

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Country	Patent Number	Title	Estimated Expiration
South Korea	101421861		⤷ Try a Trial
Cyprus	2019025		⤷ Try a Trial
Taiwan	201139409	Non-nucleoside reverse transcriptase inhibitors	⤷ Try a Trial
Japan	5281718		⤷ Try a Trial
Hong Kong	1209121	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)	⤷ Try a Trial
Tunisia	2012000455	NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for doravirine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	LUC00113	Luxembourg	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
2552902	CA 2019 00025	Denmark	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2924034	19C1025	France	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE L0181126 AMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 2
2924034	C20190025 00305	Estonia	⤷ Try a Trial	PRODUCT NAME: DORAVIRIIN/LAMIVUDIIN/TENOFOVIIRDISOPROKSIIL;REG NO/DATE: EU/1/18/1333 26.11.2018
2552902	24/2019	Austria	⤷ Try a Trial	PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
2924034	C201930027	Spain	⤷ Try a Trial	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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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.