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Last Updated: September 30, 2022

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-four drug master file entries for sitagliptin phosphate. Three suppliers are listed for this compound. There are twelve 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
Blandine LaferrereN/A

See all sitagliptin phosphate clinical trials

Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing25MGTABLET;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 021995-002 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 See Plans and Pricing See Plans and Pricing
>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
0896538 91334 Luxembourg See Plans and Pricing CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1412357 SPC024/2008 Ireland See Plans and Pricing SPC024/2008: 20090921, EXPIRES: 20230407
1412357 0790041-8 Sweden See Plans and Pricing PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357 300357 Netherlands See Plans and Pricing 300357, 20220705, EXPIRES: 20230715
>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.