Viewing data from:

JENLOGA

NDA

CLONIDINE HYDROCHLORIDE | N022331 | CONCORDIA PHARMACEUTICALS INC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Arent Fox LLP - Citizen Petition FDA-2012-P-0050 · 3 docket documents Arent Fox LLP filed this citizen petition on January 10, 2012, requesting that the FDA Commissioner determine that Shionogi Inc.'s Jenloga (clonidine hydrochloride) 0.1 mg and 0.2 mg extended-release tablets and Kapvay (clonidine hydrochloride) 0.2 mg extended-release tablets, both approved under ND	505(q)	2012-01-24	Open	—
Actavis Inc. - Citizen Petition FDA-2011-P-0291 · 5 docket documents Actavis Inc. filed this citizen petition on April 20, 2011, requesting that the FDA determine that JENLOGA (clonidine hydrochloride) Extended-Release Tablets in 0.1 mg and 0.2 mg strengths, approved under NDA 22-331, were not voluntarily withdrawn for safety or efficacy reasons. Actavis sought this	505(q)	2011-04-29	Granted	—
Actavis Inc. - Citizen Petition FDA-2011-P-0292 · 5 docket documents Actavis Inc. submitted this citizen petition on April 20, 2011 requesting that the FDA determine that KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 mg, approved under NDA 22-331, was not voluntarily withdrawn for safety or efficacy reasons, as the product was never commercially mark	505(q)	2011-04-29	Granted	—

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

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.

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

8 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2020	SUPPL -21	View Letter (PDF)
Aug 16, 2016	SUPPL -13	View Letter (PDF)
Jun 10, 2015	SUPPL -15	View Letter (PDF)
Nov 21, 2014	SUPPL -14	View Letter (PDF)
Feb 14, 2013	SUPPL -12	View Letter (PDF)
Oct 4, 2010	SUPPL -5	View Letter (PDF)
Oct 4, 2010	SUPPL -1	View Letter (PDF)
Oct 7, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 30, 2009

No patent or exclusivity listings for this strength.

#002 — 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 25, 2010

#003 — 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 28, 2010

#004 — 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 28, 2010