Viewing data from:

NOURIANZ

NDA

ISTRADEFYLLINE | N022075 | KYOWA KIRIN INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

7727993

Jan. 28, 2028

8318201

Sep. 5, 2027

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
KYOWA KIRIN CO., LTD. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 1:2025cv17403 1 patentANDA 220691istradefylline	D.N.J.	2025-11-13	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 Nourianz (2023)

Total Spending

$49.7M

Total Claims

19,080

Beneficiaries

3,546

Avg Cost/Unit

$61.92

Spending Trend

$314K(2019)→$19.5M(2020)→$37.5M(2021)→$45.1M(2022)→$49.7M(2023)

YoY Change:+5.3%

5yr CAGR:+5.1%

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

API Supply Chain5 active DMFs1 inactive

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

ALP PHARM BEIJING CO LTDISTRADEFYLLINE

DMF 376542022

PROCOS SPAISTRADEFYLLINE

DMF 382122023

MSN LIFE SCIENCES PRIVATE LTDISTRADEFYLLINE

DMF 387212023

HOSTER LABS PRIVATE LTDISTRADEFYLLINE

DMF 400302024

SUN PHARMACEUTICAL INDUSTRIES LTDISTRADEFYLLINE

DMF 417472025

KYOWA HAKKO KIRIN CO LTDInactiveISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE

DMF 239362010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 29, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 27, 2019

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7727993	Jan 28, 2028	—	—	Yes		—
8318201	Sep 5, 2027	—	—	Yes	—	—

#002 — 40MG

RLD

2 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 27, 2019