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Serving hundreds of leading biopharmaceutical companies globally:

US Army
QuintilesIMS
Colorcon
Queensland Health
Mallinckrodt
Deloitte
Farmers Insurance
Fish and Richardson
McKinsey

Generated: September 26, 2018

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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.

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.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 Oct 7, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-003 Oct 7, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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

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 ➤ Try a Free Trial
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008013 Lithuania ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
3 Finland ➤ Try a Free Trial
1412357/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
/2008 Austria ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
2008013,C1412357 Lithuania ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
470 Luxembourg ➤ Try a Free Trial 91470, EXPIRES: 20280818
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
QuintilesIMS
Colorcon
Queensland Health
Mallinckrodt
Deloitte
Farmers Insurance
Fish and Richardson
McKinsey

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