Viewing data from:

NITYR

NDA

NITISINONE | N209449 | CYCLE PHARMACEUTICALS LTD

4 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

10328029

Jan. 5, 2035

ODE-529

Jun. 10, 2032

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Nityr (2023)

Total Spending

$30K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$91.78

Spending Trend

$27K(2020)→$240K(2021)→$30K(2023)

5yr CAGR:+4.1%

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

API Supply Chain4 active DMFs1 inactive

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

NOVITIUM PHARMA LLCNITISINONE

DMF 312502017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNITISINONE

DMF 339482019

SCL LIFESCIENCES LTDNITISINONE

DMF 358102021

DIPHARMA SANITISINONE

DMF 360262021

ZYDUS LIFESCIENCES LTDInactiveNITISINONE

DMF 306802016

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2025	SUPPL -18	View Letter (PDF)
Jan 19, 2024	SUPPL -17	View Letter (PDF)
Oct 20, 2020	SUPPL -5	View Letter (PDF)
Nov 15, 2018	SUPPL -6	View Letter (PDF)
Jul 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#004 — 2MG

RLD

0 patents1 exclusivity▾

TABLET;ORAL | Approved: Jun 10, 2025

#001 — 2MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jul 26, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10328029	Jan 5, 2035	—	—	Yes		—

#002 — 5MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jul 26, 2017

#003 — 10MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jul 26, 2017

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Cycle Pharmaceuticals gained orphan drug exclusivity for Nityr (nitisinone) under ODE-529, effective for the indication covered by NDA 209449.

New: New record