Alogliptin benzoate; metformin hydrochloride - Generic Drug Details
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What are the generic drug sources for alogliptin benzoate; metformin hydrochloride and what is the scope of patent protection?
Alogliptin benzoate; metformin hydrochloride
is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alogliptin benzoate; metformin hydrochloride has ninety patent family members in forty-one countries.
Three suppliers are listed for this compound.
Summary for alogliptin benzoate; metformin hydrochloride
International Patents: | 90 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for alogliptin benzoate; metformin hydrochloride |
DailyMed Link: | alogliptin benzoate; metformin hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate; metformin hydrochloride
Generic Entry Date for alogliptin benzoate; metformin hydrochloride*:
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 alogliptin benzoate; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Takeda | Phase 4 |
Celltrion Pharm, Inc. | Phase 4 |
Seoul National University Hospital | Phase 4 |
See all alogliptin benzoate; metformin hydrochloride clinical trials
Pharmacology for alogliptin benzoate; metformin hydrochloride
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for alogliptin benzoate; metformin hydrochloride
Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KAZANO | Tablets | alogliptin benzoate; metformin hydrochloride | 12.5 mg/500 mg and 12.5 mg/1000 mg | 203414 | 3 | 2017-01-25 |
US Patents and Regulatory Information for alogliptin benzoate; metformin hydrochloride
Expired US Patents for alogliptin benzoate; metformin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for alogliptin benzoate; metformin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20100036367 | SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE | ⤷ Sign Up |
China | 102127053 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
China | 102134229 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
Hong Kong | 1083338 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
China | 1926128 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | SPC/GB14/083 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923 |
1586571 | PA2014011,C1586571 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919 |
1586571 | 16/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923 |
1084705 | CA 2014 00066 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919 |
1586571 | 132014902238640 | Italy | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIPIDIA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/13/844/001 A EU/1/13/844/027, 20130923 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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