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Serving 500+ biopharmaceutical companies globally:

Novartis
Chinese Patent Office
QuintilesIMS
Teva
Johnson and Johnson
Healthtrust
Daiichi Sankyo
Dow
US Army
Fish and Richardson

Generated: June 23, 2017

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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 eighty-two patent family members in forty-six countries.

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

Summary for Generic Name: sitagliptin phosphate

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list26
Suppliers / Packagers: see list5
Bulk Api Vendors: see list132
Clinical Trials: see list1,119
Patent Applications: see list4,874
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
► Subscribe► Subscribe25MGTABLET;ORAL
► Subscribe► Subscribe100MGTABLET;ORAL
► Subscribe► 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;ORAL021995-003Oct 16, 2006RXYesYes6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo7,125,873► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo7,078,381► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes7,459,428► Subscribe ► 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;ORAL021995-003Oct 16, 20066,303,661► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 20066,303,661► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 20066,303,661► 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
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► 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
Japan2010248253► Subscribe
Jordan2230► Subscribe
Jordan2625► Subscribe
Dominican RepublicP2004000941► Subscribe
MexicoPA05013931► 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
1084705/05Switzerland► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
/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
382Luxembourg► Subscribe91382, EXPIRES: 20220424
1084705/02Switzerland► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
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 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:

US Army
UBS
Cipla
Baxter
Fish and Richardson
Chubb
Healthtrust
Novartis
Merck
Julphar

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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