.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chubb
McKesson
Fuji
Fish and Richardson
Federal Trade Commission
Argus Health
Merck
US Department of Justice
Dow
Healthtrust

Generated: December 15, 2017

DrugPatentWatch Database Preview

Sitagliptin phosphate - Generic Drug Details

« Back to Dashboard

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-six patent family members in forty-seven 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.

Pharmacology for sitagliptin phosphate

Medical Subject Heading (MeSH) Categories for 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► 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
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
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
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: sitagliptin phosphate

Country Document Number Estimated Expiration
Russian Federation2305553► Subscribe
Portugal1084705► Subscribe
Ukraine86026► Subscribe
South Korea20040010842► Subscribe
European Patent Office1654263► Subscribe
Iceland7062► Subscribe
Iceland2218► Subscribe
Germany122007000038► Subscribe
Norway20031574► Subscribe
Germany122010000020► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: SITAGLIPTIN PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
C/GB14/084United Kingdom► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
90041-8Sweden► SubscribePRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
2007 00040Denmark► Subscribe
C024/2008Ireland► SubscribeSPC024/2008: 20090921, EXPIRES: 20230407
1084705/04Switzerland► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
334Luxembourg► SubscribeCERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
2014 00065Denmark► SubscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Chubb
Moodys
Cipla
Queensland Health
Healthtrust
Medtronic
Dow
Boehringer Ingelheim
Federal Trade Commission

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot