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Last Updated: July 23, 2021

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SITAGLIPTIN PHOSPHATE - Generic Drug Details

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What are the generic sources for sitagliptin phosphate and what is the scope of 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 three 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 twenty-seven patent family members in forty-six countries.

There are thirty-five drug master file entries for sitagliptin phosphate. One supplier is listed for this compound. There are ten tentative approvals for this compound.

Recent Clinical Trials for SITAGLIPTIN PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
University of Colorado, DenverN/A

See all SITAGLIPTIN PHOSPHATE clinical trials

Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free100MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free50MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free25MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SITAGLIPTIN PHOSPHATE
Medical Subject Heading (MeSH) Categories for SITAGLIPTIN PHOSPHATE
Paragraph IV (Patent) Challenges for SITAGLIPTIN PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-11-06
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-25
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-19
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2010-10-18

US Patents and Regulatory Information for SITAGLIPTIN PHOSPHATE

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;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SITAGLIPTIN PHOSPHATE

Supplementary Protection Certificates for SITAGLIPTIN PHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 SPC/GB14/082 United Kingdom ⤷  Try it Free PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
1412357 77 5006-2008 Slovakia ⤷  Try it Free PRODUCT 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
1412357 C200700039 Spain ⤷  Try it Free PRODUCT NAME: SITAGLIPTINA; NATIONAL AUTHORISATION NUMBER: EU/1/07/383/001-018; DATE OF AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001-018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1084705 CA 2014 00063 Denmark ⤷  Try it Free PRODUCT 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
1412357 07C0041 France ⤷  Try it Free PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
1412357 122008000046 Germany ⤷  Try it Free PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1412357 C 2008 016 Romania ⤷  Try it Free PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Colorcon
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson

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