Viewing data from:

NESINA

NDA

ALOGLIPTIN BENZOATE | N022271 | TAKEDA PHARMACEUTICALS USA INC

3 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

Today

7807689

Jun. 27, 2028

8697125

Jun. 16, 2029

M-300

Jul. 27, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TAKEDA PHARMACEUTICAL COMPANY LTD. et al v. TORRENT PHARMACEUTICALS LTD. et al 2:2017cv03186 4 patentsANDA 21-0159, 21-0160, 21-0161alogliptin benzoate	D.N.J.	2017-05-05	Terminated 2020-02-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nesina (2023)

Total Spending

$400K

Total Claims

916

Beneficiaries

389

Avg Cost/Unit

$12.13

Spending Trend

$1.0M(2019)→$618K(2020)→$360K(2021)→$373K(2022)→$400K(2023)

YoY Change:-7.0%

5yr CAGR:-0.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs

15 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDALOGLIPTIN BENZOATE

DMF 279932014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDALOGLIPTIN BENZOATE

DMF 281872014

MSN LABORATORIES PRIVATE LTDALOGLIPTIN BENZOATE [ROUTE CODE "LB"]

DMF 294272015

ALIVUS LIFE SCIENCES LTDALOGLIPTIN BENZOATE

DMF 300572016

ALEMBIC PHARMACEUTICALS LTDALOGLIPTIN BENZOATE

DMF 300932015

HONOUR LAB LTDALOGLIPTIN BENZOATE

DMF 305772016

INDOCO REMEDIES LTDALOGLIPTIN BENZOATE

DMF 306122016

RUYUAN HEC PHARM CO LTDALOGLIPTIN BENZOATE NON-STERILE BULK DRUG SUBSTANCE

DMF 309132016

WISDOM PHARMACEUTICAL CO LTDALOGLIPTIN BENZOATE

DMF 312932016

FUXIN LONG RUI PHARMACEUTICAL CO LTDALOGLIPTIN BENZOATE

DMF 333782018

TORRENT PHARMACEUTICALS LTDALOGLIPTIN BENZOATE

DMF 354142020

METROCHEM API PRIVATE LTDALOGLIPTIN BENZOATE

DMF 379082022

SHANDONG LUNING PHARMACEUTICAL CO LTDALOGLIPTIN BENZOATE

DMF 393762024

WISDOM PHARMACEUTICAL CO LTDALOGLIPTIN BENZOATE

DMF 399842024

ZHEJIANG KINGLAND PHARMACEUTICAL CO LTDALOGLIPTIN BENZOATE

DMF 410052024

CTX LIFESCIENCES PVT LTDALOGLIPTIN BENZOATE IH

DMF 421022025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2023	SUPPL -15	View Letter (PDF)
Mar 14, 2022	SUPPL -13	View Letter (PDF)
Jul 2, 2019	SUPPL -12	View Letter (PDF)
Dec 14, 2016	SUPPL -11	View Letter (PDF)
May 31, 2016	SUPPL -9	View Letter (PDF)
Apr 7, 2016	SUPPL -5	View Letter (PDF)
Sep 1, 2015	SUPPL -7	View Letter (PDF)
Jan 30, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 6.25MG BASE

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Jan 25, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7807689	Jun 27, 2028	—	Yes	Yes		—
8697125	Jun 16, 2029	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-300	Jul 27, 2026	< 1 year

#002 — EQ 12.5MG BASE

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 25, 2013

#003 — EQ 25MG BASE

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 25, 2013