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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Teva
AstraZeneca
Merck
Baxter
Dow
Covington
McKinsey

Generated: June 23, 2018

DrugPatentWatch Database Preview

JUVISYNC Drug Profile

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Which patents cover Juvisync, and what generic alternatives are available?

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 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 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 202343-003 Oct 7, 2011 ➤ 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 202343-006 Sep 18, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-001 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 Submissiondate
➤ Subscribe Tablets 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg ➤ Subscribe 2012-11-06
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-19
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-25

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
7,829,530 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
9,044,424 Methods 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
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2 Finland ➤ Sign Up
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
2008000046 Germany ➤ Sign Up PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Johnson and Johnson
Medtronic
Citi
Healthtrust
Dow
Boehringer Ingelheim
Cantor Fitzgerald

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