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JUVISYNC Drug Profile

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Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and seventy-eight patent family members in forty-six 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 Tradename: JUVISYNC

Patents:8
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNNo7,125,873► subscribeY ► subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNNo6,699,871► subscribeYY ► subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-005Sep 18, 2012DISCNNo7,078,381► subscribe ► subscribe
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Paragraph IV activity for: JUVISYNC

Drugname Dosage Strength RLD Submissiondate
sitagliptin phosphate and simvastatinTablets50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mgJuvisync11/6/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJuvisync6/19/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJuvisync6/25/2012

Non-Orange Book Patents for Tradename: 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
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: JUVISYNC

Country Document Number Estimated Expiration
China1832949► subscribe
Iceland8183► subscribe
Norway2008013► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: JUVISYNC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0280Netherlands► subscribe300280, 20170424, EXPIRES: 20220320
00706Netherlands► subscribePRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
C/GB14/083United Kingdom► subscribePRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
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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.

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