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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
McKesson
Boehringer Ingelheim
Julphar
QuintilesIMS
Harvard Business School
US Army
Cipla
Teva

Generated: August 18, 2017

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 eight 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 eighty-three patent family members in forty-six countries.

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

Summary for Generic Name: simvastatin; sitagliptin phosphate

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list39
Clinical Trials: see list1,563
Drug Prices:see low prices
DailyMed Link:simvastatin; sitagliptin phosphate at DailyMed
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;ORAL202343-005Sep 18, 2012DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-004Sep 18, 2012DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: simvastatin; sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-005Sep 18, 2012► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-004Sep 18, 2012► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-001Oct 7, 2011► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-006Sep 18, 2012► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method 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 Ingredient: simvastatin; sitagliptin phosphate

Country Document Number Estimated Expiration
Taiwan200524610► Subscribe
BrazilPI0411726► Subscribe
Austria373003► Subscribe
Germany60210093► Subscribe
Malaysia139595► 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: SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00061Denmark► Subscribe
/2008Austria► SubscribePRODUCT 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
C/GB07/046United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/046 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT SITAGLIPTIN PHOSPHATE MONOHYDRATE, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6212 DATED 11/06/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/03/2022.
2014041Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
C/GB14/082United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Fish and Richardson
Dow
Julphar
Chinese Patent Office
Express Scripts
Baxter
McKinsey
Cantor Fitzgerald

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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