Viewing data from:

HYDREA

NDA

HYDROXYUREA | N016295 | WAYLIS THERAPEUTICS LLC

4 strengths0 unique patents0 unique exclusivities

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Duramed Pharmaceuticals, Inc. FDA-1996-P-0107 Duramed Pharmaceuticals, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA permit acceptance of an Abbreviated New Drug Application for a 250 mg capsule strength of Hydroxyurea Capsules and amend the suitability list to include	Other	2009-06-10	Open	Duramed Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)NCT06439082	Phase 3	Recruiting	Novartis Pharmaceuticals	315	2024-10-24 → 2030-04-19

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Hydrea (2023)

Total Spending

$40K

Total Claims

394

Beneficiaries

101

Avg Cost/Unit

$1.33

Spending Trend

$81K(2019)→$80K(2020)→$67K(2021)→$55K(2022)→$40K(2023)

YoY Change:-3.9%

5yr CAGR:-0.6%

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

API Supply Chain4 active DMFs6 inactive

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

OLON SPAHYDROXYUREA

DMF 118991996

ARCHIMICA SPAHYDROXYUREA

DMF 127541997

SHANDONG ANXIN PHARMACEUTICAL CO LTDHYDROXYUREA USP (NON-STERILE BULK)

DMF 206152007

OLON SPAHYDROXYUREA

DMF 371462022

FERMENTA FRANCE SAInactiveHYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)

DMF 22581974

SQUIBBInactiveHYDROXYUREA

DMF 22591974

SQUIBB MARK DIV ER SQUIBB AND SONS INCInactiveHYDROXYUREA LYOPHILIZED POWDER

DMF 83611989

MEDEA RESEARCH LABORATORIES INCInactiveHYDROXYUREA

DMF 92411991

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveHYDROXYUREA

DMF 98501992

CHEMSPECInactiveHYDROXYUREA

DMF 164582003

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

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2024	SUPPL -59	View Letter (PDF)
Nov 29, 2023	SUPPL -58	View Letter (PDF)
Jun 8, 2023	SUPPL -57	View Letter (PDF)
Jan 18, 2022	SUPPL -56	View Letter (PDF)
Aug 6, 2021	SUPPL -55	View Letter (PDF)
Feb 10, 2021	SUPPL -54	View Letter (PDF)
Dec 23, 2019	SUPPL -52	View Letter (PDF)
Jul 23, 2019	SUPPL -51	View Letter (PDF)
Dec 20, 2017	SUPPL -49	View Letter (PDF)
Dec 20, 2017	SUPPL -50	View Letter (PDF)
Mar 25, 2016	SUPPL -47	View Letter (PDF)
Jul 20, 2015	SUPPL -46	View Letter (PDF)
Jul 20, 2015	SUPPL -45	View Letter (PDF)
Jan 30, 2012	SUPPL -42	View Letter (PDF)
Jan 30, 2012	SUPPL -41	View Letter (PDF)
May 12, 2010	SUPPL -40	View Letter (PDF)
Sep 20, 2006	SUPPL -39	View Letter (PDF)
Mar 2, 2004	SUPPL -37	View Letter (PDF)
Jul 6, 2003	SUPPL -36	View Letter (PDF)
Apr 4, 2001	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 200MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 25, 1998

#003 — 300MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 25, 1998

#004 — 400MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 25, 1998

#001 — 500MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.