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Serving leading biopharmaceutical companies globally:

UBS
Healthtrust
Farmers Insurance
AstraZeneca
Chubb
Mallinckrodt
Cantor Fitzgerald
Merck
Boehringer Ingelheim
Express Scripts

Generated: December 16, 2017

DrugPatentWatch Database Preview

JUVISYNC Drug 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 are eight patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and ninety-seven patent family members in forty-seven countries and sixty-nine supplementary protection certificates in fourteen countries.

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

Summary for JUVISYNC

Drug patent expirations by year for JUVISYNC

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-005Sep 18, 2012DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-005Sep 18, 2012DISCNYesNo► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-004Sep 18, 2012DISCNYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for JUVISYNC

Drugname Dosage Strength RLD Submissiondate
sitagliptin phosphate and simvastatinTablets50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mgJuvisync11/6/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJuvisync6/19/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJuvisync6/25/2012

Non-Orange Book Patents for Tradename: JUVISYNC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► Subscribe
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: JUVISYNC

Country Document Number Estimated Expiration
SloveniaEP1412357► Subscribe
South Korea20060026061► Subscribe
Serbia20050947► Subscribe
European Patent Office2583675► Subscribe
China1132578► Subscribe
Spain2344846► Subscribe
China1216468► Subscribe
Canada2423025► Subscribe
Portugal1654263► Subscribe
Israel172563► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0357Netherlands► Subscribe300357, 20220705, EXPIRES: 20230715
0287Netherlands► Subscribe300287, 20220705, EXPIRES: 20220320
0080004 00019Estonia► SubscribePRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
1084705/05Switzerland► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
00708Netherlands► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
470Luxembourg► Subscribe91470, EXPIRES: 20280818
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
0280Netherlands► Subscribe300280, 20170424, EXPIRES: 20220320
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Accenture
Mallinckrodt
Boehringer Ingelheim
Deloitte
UBS
Citi
Johnson and Johnson
Merck
Federal Trade Commission

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 verifification 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.

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