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Last Updated: February 18, 2020

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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.

This drug has one hundred and forty-four patent family members in forty-five countries.

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.

US ANDA Litigation and Generic Entry Outlook for Juvisync

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 11, 2026. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for JUVISYNC
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.

Recent Litigation for JUVISYNC

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation2019-08-08
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc.2019-02-13

See all JUVISYNC litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals, Inc.2019-10-30

See all JUVISYNC litigation

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   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 Oct 7, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for JUVISYNC

Supplementary Protection Certificates for JUVISYNC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 42/2007 Austria   Start Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
1412357 343 Finland   Start Trial
1412357 DO 77; 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357 PA2007006,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
0720599 122004000026 Germany   Start Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Baxter
Mallinckrodt
Medtronic
Dow

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.