Viewing data from:

JAVADIN

NDA

CLONIDINE HYDROCHLORIDE | N220256 | AZURITY PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

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Today

12233049

Jul. 15, 2042

12440474

Jul. 15, 2042

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

174 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 114 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia NCT03121261	Phase 4	Active	University Hospital Dubrava	60	2017-05-01 → 2028-10
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy NCT03092011	Phase 4	Active	The Cooper Health System	69	2018-02-21 → 2026-12-01
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients NCT01530373	Phase 2	Recruiting	University of Arkansas	110	2012-02 → 2028-09
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease NCT01370811	Phase 2	Completed	Orient Pharma Co., Ltd.	24	2011-08 → 2012-09
Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery NCT01597427	Phase 2	Completed	Federal University of São Paulo	29	2009-03 → 2012-03
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine NCT01620112	Phase 2	Completed	Universidade Federal do Rio de Janeiro	60	2009-02 → 2011-07
Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure NCT01761916	Phase 4	Completed	Instituto Materno Infantil Prof. Fernando Figueira	90	2013-01 → 2013-06
Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?NCT02276495	N/A	Completed	University of California, Irvine	55	2015-01-01 → 2024-09-30
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?NCT02361476	Phase 4	Completed	Rigshospitalet, Denmark	379	2015-01 → 2015-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.53

per ml

Lowest NADAC/Unit

$1.53

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24338011501JAVADIN 0.02 MG/ML SOLUTION	$1.53	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain5 active DMFs6 inactive

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

PCASCLONIDINE HYDROCHLORIDE

DMF 47781983

UNICHEM LABORATORIES LTDCLONIDINE HYDROCHLORIDE USP

DMF 169292003

ALEMBIC PHARMACEUTICALS LTDCLONIDINE HYDROCHLORIDE USP

DMF 223622008

YUNG ZIP CHEMICAL IND CO LTDCLONIDINE HYDROCHLORIDE

DMF 239062010

ENALTEC LABS PRIVATE LTDCLONIDINE HYDROCHLORIDE USP

DMF 313862017

LUSOCHIMICA SPAInactiveCLONIDINE HYDROCHLORIDE

DMF 59981985

ORCHIMIE SAInactiveCLONIDINE HYDROCHLORIDE

DMF 60141985

YUNG ZIP CHEMICAL INDUSTRY COMPANY LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 61281985

DAIWA PHARMACEUTICAL CO LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63071986

UNICHEM LABORATORIES LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63571986

KV PHARMACEUTICAL COInactiveCLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG.

DMF 76311988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 27, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.02MG/ML

RLD

2 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 23, 2025

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12233049	Jul 15, 2042	—	—	Yes	—	—
12440474	Jul 15, 2042	—	—	Yes	—	—