Sitagliptin phosphate - Generic Drug Details
✉ Email this page to a colleague
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.
Summary for sitagliptin phosphate
International Patents: | 52 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 34 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 44 |
Patent Applications: | 114 |
Drug Prices: | Drug price trends for sitagliptin phosphate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sitagliptin phosphate |
DailyMed Link: | sitagliptin phosphate at DailyMed |
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
Sponsor | Phase |
---|---|
Galenicum Health | Phase 1 |
The Affiliated Hospital of Qingdao University | Phase 1 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 50MG | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | 25MG | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | 100MG | 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
Anatomical Therapeutic Chemical (ATC) Classes 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 | 021995-001 | Oct 16, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sitagliptin phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I347185 | ⤷ Try for Free | |
Costa Rica | 8117 | SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2005003135 | ⤷ Try for Free | |
Brazil | PI0411726 | composto, monoidrato, sal, composição farmacêutica, método para o tratamento de diabetes tipo 2, processo para preparar o composto, uso do composto, e, processo para a preparação do monoidrato cristalino | ⤷ Try for Free |
Slovenia | 1654263 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sitagliptin phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0896538 | 07C0035 | France | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321 |
1412357 | C300357 | Netherlands | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
1412357 | 300287 | Netherlands | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070323 |
1412357 | SPC/GB07/046 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323 |
1084705 | C300705 | Netherlands | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Sitagliptin Phosphate
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
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.