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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Merck Sharp & Dohme LLC	Phase 3
Prism Health North Texas	Phase 3

See all doravirine; lamivudine; tenofovir disoproxil fumarate clinical trials

Pharmacology for doravirine; lamivudine; tenofovir disoproxil fumarate

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

Anatomical Therapeutic Chemical (ATC) Classes for doravirine; lamivudine; tenofovir disoproxil fumarate

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

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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	⤷ 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
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	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

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Country	Patent Number	Title	Estimated Expiration
Mexico	2012011379	INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.)	⤷ Sign Up
Cyprus	2019026		⤷ Sign Up
Taiwan	I458719		⤷ Sign Up
Norway	2019018		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	122019000042	Germany	⤷ Sign Up	PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902	132019000000060	Italy	⤷ Sign Up	PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMAEUTICAMENTE ACCETTABILE(PIFELTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1332, 20181127
2924034	25/2019	Austria	⤷ Sign Up	PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, INSBESONDERE EINEM DISOPROXILESTER ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, INSBESONDERE EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
2924034	2019018	Norway	⤷ Sign Up	PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV I KOMBINASJON MED LAMIVUDIN OG I KOMBINASJON MED TENOFOVIRDISOPROKSIL FUMARAT; REG. NO/DATE: EU/1/18/1333/001-2 20181213
>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.