DrugPatentWatch Database Preview

DELSTRIGO Drug Profile

Email this page to a colleague

« Back to Dashboard

When do Delstrigo patents expire, and when can generic versions of Delstrigo launch?

Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-six patent family members in forty-two countries.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Delstrigo

Delstrigo will be eligible for patent challenges on August 30, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DELSTRIGO

International Patents:	76
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
DailyMed Link:	DELSTRIGO at DailyMed

Generic Entry Opportunity Date for DELSTRIGO

NDA:

210807

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 DELSTRIGO

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

Sponsor	Phase
Willem Daniel Francois Venter	Phase 3
Thomas Jefferson University	Phase 1
David Garcia Cinca	Phase 4

See all DELSTRIGO clinical trials

Pharmacology for DELSTRIGO

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Hepatitis B Virus 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

US Patents and Regulatory Information for DELSTRIGO

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			Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes

International Patents for DELSTRIGO

Country	Patent Number	Estimated Expiration
Peru	20130158
Australia	2011235568
South Korea	101421861
Tunisia	2012000455
China	108367008
Japan	2018535991
Hungary	E031785

Supplementary Protection Certificates for DELSTRIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	122019000042	Germany		PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, EINSCHLIESSLICH EINEM DISOPROXILESTER, ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, EINSCHLIESSLICH EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902	2019/020	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1332/001, EU/1/18/1332/002, EU/1/18/1333/001, EU/1/18/1333/002, 20181122
2924034	300981	Netherlands		PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
2924034	19C1025	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034	2019C/005	Belgium		PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2552902	CA 2019 00025	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126