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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Moodys
Mallinckrodt
US Department of Justice
Citi
Daiichi Sankyo
Chinese Patent Office
McKesson

Generated: July 19, 2018

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 seven patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and forty-one patent family members in forty-five 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.
Summary for JUVISYNC
Drug patent expirations by year for JUVISYNC
Generic Entry Opportunity Date for JUVISYNC
Generic Entry Date for JUVISYNC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for 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 202343-003 Oct 7, 2011 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 ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 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

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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 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-004 Sep 18, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-003 Oct 7, 2011 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 Oct 7, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for JUVISYNC
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for 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
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,440,668 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes ➤ Sign Up
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3 Finland ➤ Sign Up
C0041 France ➤ Sign Up PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
00287 Netherlands ➤ Sign Up PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0287 Netherlands ➤ Sign Up 300287, 20220705, EXPIRES: 20220320
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Accenture
Covington
Express Scripts
Moodys
Mallinckrodt
QuintilesIMS
Harvard Business School

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.