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.
Summary for sitagliptin phosphate
International Patents: | 127 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 34 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 40 |
Patent Applications: | 133 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sitagliptin phosphate |
DailyMed Link: | sitagliptin phosphate at DailyMed |
Recent Clinical Trials for sitagliptin phosphate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Affiliated Hospital of Qingdao University | Phase 1 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
Merck Sharp & Dohme Corp. | N/A |
Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 100MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 50MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 25MG | TABLET;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
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
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
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 | 021995-003 | 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 |
International Patents for sitagliptin phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Iceland | 8183 | Fosfórsýru salt af dípeptídýl peptíðasa-IV hindra | See Plans and Pricing |
Portugal | 1412357 | See Plans and Pricing | |
Taiwan | I226331 | See Plans and Pricing | |
Eurasian Patent Organization | 200501805 | See Plans and Pricing | |
Costa Rica | 7235 | INHIBIDORES BETA- AMINO TETRAHIDROIMIDAZOL (1,2-A) PIRAZINAS Y TETRAHIDROTRIOAZOLO (4,3-A) PIRAZINAS COMO DEPETIDIL PEPTIDASA PARA EL TRATAMIENTO O PREVENCION DE LA DIABETES | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sitagliptin phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | 106 4-2007 | Slovakia | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321 |
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 | 77 5006-2008 | Slovakia | See Plans and Pricing | 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 | 42/2007 | Austria | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323 |
1084705 | SPC/GB14/082 | United Kingdom | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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