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Last Updated: October 24, 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 freedom to operate?

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. Three suppliers are listed for this compound. There are eleven 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
⤷  Free Forever Trial⤷  Free Forever Trial100MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial50MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial25MGTABLET;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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 300357 Netherlands ⤷  Free Forever Trial 300357, 20220705, EXPIRES: 20230715
1412357 2007/029 Ireland ⤷  Free Forever Trial PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1412357 C 2008 016 Romania ⤷  Free Forever Trial 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:

Baxter
Mallinckrodt
AstraZeneca
Medtronic
McKinsey
Colorcon

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