IDVYNSO Drug Patent Profile

« Back to Dashboard

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

Idvynso is a drug marketed by MSD and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in IDVYNSO is doravirine; islatravir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the doravirine; islatravir profile page.

DrugPatentWatch^® Generic Entry Outlook for Idvynso

Idvynso will be eligible for patent challenges on April 20, 2030. 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 April 20, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IDVYNSO

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in IDVYNSO?	IDVYNSO excipients list
DailyMed Link:	IDVYNSO at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216964

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.

Pharmacology for IDVYNSO

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

US Patents and Regulatory Information for IDVYNSO

IDVYNSO is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd	IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964-001	Apr 20, 2026		RX	Yes	Yes			Y	Y
Msd	IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964-001	Apr 20, 2026		RX	Yes	Yes				Y
Msd	IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964-001	Apr 20, 2026		RX	Yes	Yes

International Patents for IDVYNSO

See the table below for patents covering IDVYNSO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E388958
Canada	2502109	DERIVE DE 2-HALOADENOSINE AVEC SUBSTITUTION SUR LE CARBONE EN POSITION 4' (4'-C-SUBSTITUTED-2-HALOADENOSINE DERIVATIVE)
Germany	602005005240
European Patent Office	1589026	Dérivés de l'adénosine 2-halogénée et substituée en 4'-C (4'-C-Substituted-2-Haloadenosine derivative)
Spain	2300892
Japan	2008069182	4'-C-SUBSTITUTED-2-HALOADENOSINE DERIVATIVE
Japan	2011256173	4'-C-SUBSTITUTED-2-HALOADENOSINE DERIVATIVE

Supplementary Protection Certificates for IDVYNSO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	300980	Netherlands		PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
2552902	PA2019506	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 20181122
2552902	LUC00113	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
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
2552902	CA 2019 00025	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2552902	2019C/004	Belgium		PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
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