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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
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Cantor Fitzgerald
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Healthtrust
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Covington

Generated: July 15, 2018

DrugPatentWatch Database Preview

Simvastatin; sitagliptin phosphate - Generic Drug Details

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What are the generic sources for simvastatin; sitagliptin phosphate and what is the scope of simvastatin; sitagliptin phosphate patent protection?

Simvastatin; sitagliptin phosphate
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Simvastatin; sitagliptin phosphate has one hundred and forty-one patent family members in forty-five countries.

There are thirty-nine drug master file entries for simvastatin; sitagliptin phosphate.
Summary for simvastatin; sitagliptin phosphate

US Patents and Regulatory Information for simvastatin; sitagliptin phosphate

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 202343-002 Oct 7, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y 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 202343-006 Sep 18, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-005 Sep 18, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ 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 simvastatin; sitagliptin phosphate

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

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Non-Orange Book US Patents for simvastatin; sitagliptin phosphate

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
8,440,668 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes ➤ Sign Up
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,157,429 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for simvastatin; sitagliptin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90041-8 Sweden ➤ Sign Up PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
1412357/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
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:

Deloitte
Moodys
McKinsey
Fish and Richardson
Chubb
Dow
Fuji
Cantor Fitzgerald
Argus Health

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