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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cipla
Federal Trade Commission
Colorcon
Harvard Business School
Merck
Johnson and Johnson
Dow
US Army

Generated: October 15, 2018

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JUVISYNC Drug Profile

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When do Juvisync patents expire, 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.

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 ➤ 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
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 202343-001 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
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

Supplementary Protection Certificates for JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005 Austria ➤ Sign Up PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
2007000056 Germany ➤ Sign Up PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
C/GB08/040 United Kingdom ➤ Sign Up PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cipla
Federal Trade Commission
Colorcon
Harvard Business School
Merck
Johnson and Johnson
Dow
US Army

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