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Last Updated: March 28, 2024

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 is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sitagliptin phosphate has fifty-two patent family members in forty countries.

There are thirty-four drug master file entries for sitagliptin phosphate. Three suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Drug Prices for sitagliptin phosphate

See drug prices for sitagliptin phosphate

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for sitagliptin phosphate
Generic Entry Date for sitagliptin phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Blandine LaferrereN/A

See all sitagliptin phosphate clinical trials

Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
JANUVIA Tablets sitagliptin phosphate 50 mg/10 mg 50 mg/20 mg 50 mg/40 mg 021995 1 2012-11-06
JANUVIA Tablets sitagliptin phosphate 100 mg/20 mg 021995 1 2012-06-25
JANUVIA Tablets sitagliptin phosphate 100 mg/10 mg and 100 mg/40 mg 021995 1 2012-06-19
JANUVIA Tablets sitagliptin phosphate 25 mg, 50 mg and 100 mg 021995 6 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 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021995-002 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sitagliptin phosphate

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20084489 PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR ⤷  Try a Trial
Peru 20050696 SAL DIHIDROGENOFOSFATO DE 4-OXO-4-[3-(TRIFLUOROMETIL)-5,6-DIHIDRO[1,2,4]TRIAZOLO[4,3-a]PIRAZIN-7(8H)-IL]-1-(2,4,5-TRIFLUOROFENIL)BUTAN-2-AMINA COMO INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA IV ⤷  Try a Trial
Spain 2291907 ⤷  Try a Trial
Eurasian Patent Organization 200600095 СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005003135 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C 2007 091 Romania ⤷  Try a Trial PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1084705 CR 2014 00063 Denmark ⤷  Try a Trial 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 20070323
1280795 122014000122 Germany ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1084705 CA 2014 00063 Denmark ⤷  Try a Trial 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 42/2007 Austria ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.