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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ANDA Consultants FDA-2017-P-5335 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Extended Release Tablets at 0.17 mg and 0.26 mg, approved under NDA 22-500 and manufactured by Tris Pharma Inc., was withdrawn from marketing for safety or effectiveness	505(q)	2017-08-30	Open	ANDA Consultants

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Catapres-Tts 3 (2023)

Total Spending

$216K

Total Claims

236

Beneficiaries

Avg Cost/Unit

$173.76

Spending Trend

$343K(2019)→$2.2M(2019)→$1.2M(2019)→$2.1M(2020)→$319K(2020)→$1.1M(2020)→$301K(2021)→$966K(2021)→$1.9M(2021)→$1.0M(2022)→$181K(2022)→$493K(2022)→$33K(2023)→$216K(2023)→$75K(2023)

YoY Change:+8.5%

5yr CAGR:+5.0%

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

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