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Boehringer Ingelheim
Fuji
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Sitagliptin phosphate - Generic Drug Details

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What are the generic drug sources for sitagliptin phosphate and what is the scope of sitagliptin phosphate patent protection?

Sitagliptin phosphate
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sitagliptin phosphate has one hundred and ninety-five patent family members in forty-six countries and sixty-eight supplementary protection certificates in fourteen countries.

There are twenty-six drug master file entries for sitagliptin phosphate. Four suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for Generic Name: sitagliptin phosphate

US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list26
Suppliers / Packagers: see list4
Bulk Api Vendors: see list132
Clinical Trials: see list1,140
Patent Applications: see list5,401
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sitagliptin phosphate at DailyMed

Pharmacology for Ingredient: sitagliptin phosphate

Tentative approvals for SITAGLIPTIN PHOSPHATE

Applicant Application No. Strength Dosage Form
u► Subscribe25MGTABLET;ORAL
u► Subscribe100MGTABLET;ORAL
u► Subscribe50MGTABLET;ORAL
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
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of 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
7,157,429Method 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
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: sitagliptin phosphate

Country Document Number Estimated Expiration
Poland196278► Subscribe
Denmark1654263► Subscribe
Germany122008000046► Subscribe
South Korea20060026061► Subscribe
Malaysia127961► Subscribe
Eurasian Patent Organization200501805► Subscribe
Eurasian Patent Organization006845► Subscribe
New Zealand544026► Subscribe
Australia721477► Subscribe
South Africa200309294► 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: SITAGLIPTIN PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007000056Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
2014044Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
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.
C/GB14/086United Kingdom► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
0070004 00113Estonia► SubscribePRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007
3Finland► Subscribe
2014 00063Denmark► SubscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
00709Netherlands► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
2007 00061Denmark► Subscribe
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Baxter
Teva
Cerilliant
Fuji
Moodys
US Army
Merck
Chinese Patent Office

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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