JUVISYNC Drug Patent Profile

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When do Juvisync patents expire, 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 and three Paragraph IV challenges.

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

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Summary for JUVISYNC

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUVISYNC
DailyMed Link:	JUVISYNC at DailyMed

Drug patent expirations by year for JUVISYNC

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

Generic Entry Date for JUVISYNC^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Paragraph IV (Patent) Challenges for JUVISYNC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	202343	1	2012-11-06
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/20 mg	202343	1	2012-06-25
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	202343	1	2012-06-19

US Patents and Regulatory Information for JUVISYNC

JUVISYNC is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JUVISYNC is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No	⤷ 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

Expired US Patents for JUVISYNC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for JUVISYNC

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

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0411726	composto, monoidrato, sal, composição farmacêutica, método para o tratamento de diabetes tipo 2, processo para preparar o composto, uso do composto, e, processo para a preparação do monoidrato cristalino	⤷ Sign Up
Peru	20050696	SAL DIHIDROGENOFOSFATO DE 4-OXO-4-[3-(TRIFLUOROMETIL)-5,6-DIHIDRO[1,2,4]TRIAZOLO[4,3-a]PIRAZIN-7(8H)-IL]-1-(2,4,5-TRIFLUOROFENIL)BUTAN-2-AMINA COMO INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA IV	⤷ Sign Up
Dominican Republic	P2002000438	INHIBIDORES DE LA DIPETIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for JUVISYNC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	SPC024/2008	Ireland	⤷ Sign Up	SPC024/2008: 20090921, EXPIRES: 20230407
1084705	PA2014043	Lithuania	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705	C300708	Netherlands	⤷ Sign Up	PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description