Viewing data from:

KATERZIA

NDA

AMLODIPINE BENZOATE | N211340 | AZURITY PHARMACEUTICALS INC

1 strength13 unique patents0 unique exclusivities

Patent Timeline

13 unique patents by expiration date

Active (13)Today

2026

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Today

Oct. 16, 2037

Apr. 11, 2039

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

Oct. 6, 2037

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. v. Annora Pharma Private Limited 1:2025cv01139 7 patentsANDA 220151amlodipine benzoate	D. Del.	2025-09-12	Active	—

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 Katerzia (2023)

Total Spending

$1.5M

Total Claims

1,800

Beneficiaries

374

Avg Cost/Unit

$3.92

Spending Trend

$130K(2019)→$1.0M(2020)→$1.4M(2021)→$1.4M(2022)→$1.5M(2023)

YoY Change:+4.7%

5yr CAGR:+2.9%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALKEM LABORATORIES LTDAMLODIPINE BENZOATE

DMF 356102021

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 4, 2025	SUPPL -1	View Letter (PDF)
Jul 8, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML

RLD

13 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jul 8, 2019

Patents (13)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10695329	Oct 16, 2037	—	—	Yes	—	—
10799453	Apr 11, 2039	—	—	Yes	—	—
10894039	Oct 6, 2037	—	—	—		—
10952998	Oct 6, 2037	—	—	Yes	—	—
10959991	Oct 6, 2037	—	—	—		—
11364230	Oct 6, 2037	—	—	Yes	—	—
11471409	Oct 6, 2037	—	—	—		—
11484498	Oct 6, 2037	—	—	Yes	—	—
11701326	Oct 6, 2037	—	—	Yes	—	—
11918685	Oct 6, 2037	—	—	—		—
12053461	Oct 6, 2037	—	—	Yes	—	—
12336984	Oct 6, 2037	—	—	—		—
12383498	Oct 6, 2037	—	—	Yes	—	—