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Serving leading biopharmaceutical companies globally:

Novartis
Fuji
Deloitte
Cantor Fitzgerald
Medtronic
Chubb
Healthtrust
Mallinckrodt
Johnson and Johnson
Cerilliant

Generated: October 18, 2017

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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 ninety-six patent family members in forty-six countries and sixty-nine supplementary protection certificates in fourteen countries.

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

Summary for Generic Name: simvastatin; sitagliptin phosphate

US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list39
Clinical Trials: see list1,570
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► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-006Sep 18, 2012DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-005Sep 18, 2012DISCNYesNo► 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;ORAL202343-001Oct 7, 2011DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-005Sep 18, 2012DISCNYesNo► Subscribe► SubscribeYY ► 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

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
8,318,669Method 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
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method 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 Ingredient: simvastatin; sitagliptin phosphate

Country Document Number Estimated Expiration
Denmark1412357► Subscribe
Australia2003264609► Subscribe
Australia721477► Subscribe
Colombia5660266► Subscribe
Norway335371► Subscribe
Malaysia139595► Subscribe
Japan2010248252► Subscribe
Germany122007000056► Subscribe
European Patent Office0896538► Subscribe
European Patent Office1654263► 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
/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
00708Netherlands► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
C/GB14/083United Kingdom► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
0357Netherlands► Subscribe300357, 20220705, EXPIRES: 20230715
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1084705/04Switzerland► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
C0035France► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
90041-8Sweden► SubscribePRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Express Scripts
US Department of Justice
Chinese Patent Office
Healthtrust
Daiichi Sankyo
Teva
Cerilliant
Fish and Richardson

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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