ALOGLIPTIN BENZOATE - Generic Drug Details

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What are the generic drug sources for alogliptin benzoate and what is the scope of freedom to operate?

Alogliptin benzoate is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate has sixty-nine patent family members in thirty-seven countries.

There are ten drug master file entries for alogliptin benzoate. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ALOGLIPTIN BENZOATE

International Patents:	69
US Patents:	6
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	6
Patent Applications:	644
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOGLIPTIN BENZOATE
DailyMed Link:	ALOGLIPTIN BENZOATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALOGLIPTIN BENZOATE

Generic Entry Date for ALOGLIPTIN BENZOATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yonsei University	Phase 4
Celltrion Pharm, Inc.	Phase 4
Takeda	Phase 4

See all ALOGLIPTIN BENZOATE clinical trials

Generic filers with tentative approvals for ALOGLIPTIN BENZOATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	6.25MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 25MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 12.5MG BASE	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 ALOGLIPTIN BENZOATE

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALOGLIPTIN BENZOATE

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NESINA	Tablets	alogliptin benzoate	6.25 mg, 12.5 mg and 25 mg	022271	5	2017-01-25

US Patents and Regulatory Information for ALOGLIPTIN BENZOATE

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Glossary

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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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ALOGLIPTIN BENZOATE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Vipidia	alogliptin benzoate	EMEA/H/C/002182 Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).	Authorised	no	no	no	2013-09-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ALOGLIPTIN BENZOATE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20070008620	DIPEPTIDYL PEPTIDASE INHIBITORS	⤷ Sign Up
Costa Rica	8595	INHIBIDOR DEL DIPEPTIDIL-PEPTIDASA	⤷ Sign Up
Japan	2010517936		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALOGLIPTIN BENZOATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	C 2014 011	Romania	⤷ Sign Up	PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1586571	1490014-6	Sweden	⤷ Sign Up	PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1084705	PA2014045	Lithuania	⤷ Sign Up	PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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