Viewing data from:

ZONISADE

NDA

ZONISAMIDE | N214273 | AZURITY PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

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2029

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2039

Today

11478456

Aug. 18, 2038

11529333

Aug. 18, 2038

12491179

Aug. 18, 2038

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

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. v. Aurobindo Pharma Limited 1:2026cv00785 3 patentsANDA 221557Zonisamide	D. Del.	2026-07-01	Active	—
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd. 1:2025cv00563 2 patentsANDA 220352Zonisamide	D. Del.	2025-05-07	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 Zonisade (2023)

Total Spending

$2.1M

Total Claims

2,020

Beneficiaries

307

Avg Cost/Unit

$2.48

Spending Trend

$113K(2022)→$2.1M(2023)

YoY Change:-0.4%

5yr CAGR:-0.4%

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

API Supply Chain13 active DMFs8 inactive

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

SUMITOMO PHARMA CO LTDZONISAMIDE DRUG SUBSTANCE

DMF 121981996

DIPHARMA FRANCIS SRLZONISAMIDE

DMF 173032004

ALIVUS LIFE SCIENCES LTDZONISAMIDE

DMF 179452004

WOCKHARDT LTDZONISAMIDE USP

DMF 180592005

SUN PHARMACEUTICAL INDUSTRIES LTDZONISAMIDE USP

DMF 181912005

ZYDUS LIFESCIENCES LTDZONISAMIDE

DMF 182072005

HETERO LABS LTDZONISAMIDE

DMF 184882005

MAITHRI DRUGS PRIVATE LTDZONISAMIDE USP

DMF 310092016

COHANCE LIFESCIENCES LTDZONISAMIDE USP

DMF 312982017

ALIVUS LIFE SCIENCES LTDZONISAMIDE USP (D270 PROCESS)

DMF 319732017

COHANCE LIFESCIENCES LTDZONISAMIDE USP

DMF 332562018

EMNAR PHARMA PRIVATE LTDZONISAMIDE USP

DMF 385242023

UNICHEM LABORATORIES LTDZONISAMIDE USP

DMF 402932024

PERRIGO API LTDInactiveZONISAMIDE

DMF 170272003

PROCOS SPAInactiveZONISAMIDE

DMF 172542004

JUZEN CHEMICAL CORPInactiveZONISAMIDE

DMF 176612004

MYLAN LABORATORIES LTDInactiveZONISAMIDE

DMF 179752005

DR REDDYS LABORATORIES LTDInactiveZONISAMIDE

DMF 181032005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveZONISAMIDE

DMF 181972005

APOTEX PHARMACHEM INCInactiveZONISAMIDE

DMF 182032005

BACHEM SAInactiveZONISAMIDE

DMF 222762008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 19, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML

RLD

3 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jul 15, 2022

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11478456	Aug 18, 2038	—	—	—		—
11529333	Aug 18, 2038	—	—	Yes	—	—
12491179	Aug 18, 2038	—	—	Yes	—	—