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KAZANO

NDA

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE | N203414 | TAKEDA PHARMACEUTICALS USA INC

2 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

8900638

May. 24, 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. INDOCO REMEDIES LTD. 2:2018cv00055 4 patentsANDA 209998alogliptin benzoate and metformin hydrochloride	D.N.J.	2018-01-03	Terminated 2018-03-08	—

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 Kazano (2023)

Total Spending

$112K

Total Claims

215

Beneficiaries

Avg Cost/Unit

$6.03

Spending Trend

$311K(2019)→$243K(2020)→$123K(2021)→$109K(2022)→$112K(2023)

YoY Change:-9.8%

5yr CAGR:-0.9%

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2023	SUPPL -16	View Letter (PDF)
Mar 14, 2022	SUPPL -13	View Letter (PDF)
Jul 2, 2019	SUPPL -12	View Letter (PDF)
Dec 14, 2016	SUPPL -9	View Letter (PDF)
Dec 14, 2016	SUPPL -8	View Letter (PDF)
Apr 7, 2016	SUPPL -3	View Letter (PDF)
Sep 1, 2015	SUPPL -5	View Letter (PDF)
Jan 30, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 12.5MG BASE;500MG

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		—
8900638	May 24, 2029	—	—	Yes	—	—

Exclusivities (1)

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

#002 — EQ 12.5MG BASE;1GM

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 25, 2013