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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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for alogliptin benzoate

International Patents:	67
US Patents:	7
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	10
Suppliers / Packagers:	2
Bulk Api Vendors:	60
Clinical Trials:	6
Patent Applications:	32
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate
DailyMed Link:	alogliptin benzoate at DailyMed

Recent Clinical Trials for alogliptin benzoate

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

Sponsor	Phase
Yonsei University	Phase 4
Takeda	Phase 3
Takeda	Phase 4

See all alogliptin benzoate clinical trials

Generic filers with tentative approvals for ALOGLIPTIN BENZOATE

Applicant	Application No.	Strength	Dosage Form
		6.25MG	TABLET;ORAL
		EQ 25MG BASE	TABLET;ORAL
		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

Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NESINA	TABLET;ORAL	alogliptin benzoate	022271	2017-01-25

US Patents and Regulatory Information for alogliptin benzoate

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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		RX	Yes	No			Y	Y

Expired US Patents for alogliptin benzoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013

International Patents for alogliptin benzoate

Country	Patent Number	Estimated Expiration
Spain	2639854
Israel	220480
South Korea	101071389
Poland	1586571
Taiwan	I344962

Supplementary Protection Certificates for alogliptin benzoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	PA2014011,C1586571	Lithuania		PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571	2014/012	Ireland		PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	2014C/010	Belgium		PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1586571	C 2014 011	Romania		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
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013