You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Alogliptin benzoate; metformin hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
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

SponsorPhase
TakedaPhase 4
Celltrion Pharm, Inc.Phase 4
Seoul National University HospitalPhase 4

See all alogliptin benzoate; metformin hydrochloride clinical trials

Pharmacology 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 alogliptin benzoate; metformin hydrochloride

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

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.