Alogliptin benzoate - Generic Drug Details

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. Three 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:	3
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	6
Patent Applications:	864
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 4
Celltrion Pharm, Inc.	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	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

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			Y	Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	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	022271-002	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013

EU/EMA Drug Approvals for alogliptin benzoate

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

International Patents for alogliptin benzoate

Country	Patent Number	Title	Estimated Expiration
Luxembourg	92374
Morocco	28469	INHIBITEURS DE LA DIPEPTIDYLE PEPTIDASE
Netherlands	300640

Supplementary Protection Certificates for alogliptin benzoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	252 5006-2014	Slovakia		PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
1586571	C20140007 00126	Estonia		PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
1586571	132014902238640	Italy		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