Viewing data from:

CATAPRES-TTS-1

NDA

CLONIDINE | N018891 | LAVIPHARM SA

3 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

5 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ANDA Consultants FDA-2017-P-5335 · 4 docket documents ANDA Consultants filed this citizen petition on August 29, 2017, requesting that the FDA determine whether Nexiclon XR (clonidine) Extended Release Tablets at 0.17 mg and 0.26 mg, approved under NDA 22-500 and manufactured by Tris Pharma Inc., was withdrawn from marketing for safety or effectiveness	505(q)	2017-08-30	Open	ANDA Consultants
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hydrochloride) Extended-Release Tablets in 0.1 mg and 0.2 mg strengths, approved under NDA 22-331, were not voluntarily withdrawn for safety or efficacy reasons.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	—
Boehringer Ingelheim Pharm, Inc. - Citizen Petition FDA-2001-P-0563 · 5 docket documents Boehringer Ingelheim Pharmaceutical, Inc. filed this citizen petition under 21 C.F.R. 350.30 and FFDCA Sections 505(b) and 505(j) requesting that FDA deny approval of Elan Pharmaceuticals' ANDA for a generic clonidine transdermal patch (Catapres-TTS equivalent) because Elan's product lacks the same	505(q)	2009-08-19	Partially Denied	—
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0489 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA take action regarding clonidine hydrochloride products listed in the Orange Book, specifically seeking clarification or regulatory action on the abbreviated new drug applications (ANDAs) and reference listed drug d	Other	2008-09-15	Denied	—

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$12.72

per ea

Lowest NADAC/Unit

$6.76

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52817061204CLONIDINE 0.3 MG/DAY PATCH	$12.72	EA	Generic	—	2026-06-17
52817061104CLONIDINE 0.2 MG/DAY PATCH	$9.59	EA	Generic	—	2026-06-17
52817061004CLONIDINE 0.1 MG/DAY PATCH	$6.76	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$8.62

Highest Price

$517.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82089-0103-34CATAPRES-TTS 3	$517.82	FSS	Technomed, Inc.	04/30/2028
52817-0610-04CLONIDINE 0.1MG/24HRS PATCH	$8.62	FSS	TruPharma, LLC	07/31/2026
52817-0611-04CLONIDINE 0.2MG/24HRS PATCH	$13.88	FSS	TruPharma, LLC	07/31/2026
52817-0612-04CLONIDINE 0.3MG/24HRS PATCH	$18.42	FSS	TruPharma, LLC	07/31/2026
82089-0101-34CATAPRES-TTS 1	$221.69	FSS	Technomed, Inc.	04/30/2028
82089-0102-34CATAPRES-TTS 2	$373.29	FSS	Technomed, Inc.	04/30/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs2 inactive

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

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLCLONIDINE HCL

DMF 44931982

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLCLONIDINE BASE

DMF 128661998

PCASCLONIDINE BASE

DMF 129641998

ZYDUS LIFESCIENCES LTDCLONIDINE

DMF 219352008

ALEMBIC PHARMACEUTICALS LTDCLONIDINE USP

DMF 284942014

CIPLA LTDInactiveCLONIDINE HCL

DMF 54461984

TEMMLER WERKE VEREINIGTE CHEMISCHE FABRIKENInactiveCLONIDINE HCL. 0.6MG. C.R. CAPSULES

DMF 58741985

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -34	View Letter (PDF)
Feb 3, 2023	SUPPL -32	View Letter (PDF)
Feb 2, 2023	SUPPL -32	View Letter (PDF)
Jun 7, 2012	SUPPL -28	View Letter (PDF)
May 3, 2010	SUPPL -27	View Letter (PDF)
Jan 7, 2010	SUPPL -25	View Letter (PDF)
Apr 14, 2006	SUPPL -24	View Letter (PDF)
Aug 25, 2004	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.1MG/24HR

RLDAB

0 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Oct 10, 1984

No patent or exclusivity listings for this strength.

#002 — 0.2MG/24HR

RLDAB

0 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Oct 10, 1984

#003 — 0.3MG/24HR

RLDAB

0 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Oct 10, 1984