Juvisync Drug Patent Profile

Which patents cover Juvisync, and when can generic versions of Juvisync launch?

Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in JUVISYNC is simvastatin; sitagliptin phosphate. There are forty drug master file entries for this compound. Additional details are available on the simvastatin; sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Juvisync

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2026. This may change due to patent challenges or generic licensing.

There have been twenty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for Juvisync

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Juvisync
DailyMed Link:	Juvisync at DailyMed

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

NDA:

202343

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.

Anatomical Therapeutic Chemical (ATC) Classes for Juvisync

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for Juvisync

Juvisync is protected by one US patents.

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

Patents protecting Juvisync

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-003	Oct 7, 2011		DISCN	Yes	No					Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012		DISCN	Yes	No					Y

Expired US Patents for Juvisync

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012

International Patents for Juvisync

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9740832
Luxembourg	92613
Japan	2014144986	METHODS OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO
Bulgaria	108493
European Patent Office	2289513
European Patent Office	1412357	BETA-AMINO-TETRAHYDROIMIDAZO(1, 2-A)PYRAZINES ET BETA-AMINO-TETRAHYDROTRIOAZOLO(4, 3-A)PYRAZINES UTILISEES EN TANT QU'INHIBITEURS DE LA DIPEPTIDYL PEPTIDASE DANS LE TRAITEMENT OU LA PREVENTION DU DIABETE (BETA-AMINO TETRAHYDROIMIDAZO(1,2-A)PYRAZINES AND TETRAHYDROTRIAZOLO(4,3-A)PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES)

Supplementary Protection Certificates for Juvisync

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
1412357	C 2007 091	Romania		PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
0896538	CA 2007 00030	Denmark
1084705	C01084705/04	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408