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Last Updated: November 21, 2024

CLONIDINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for clonidine hydrochloride and what is the scope of freedom to operate?

Clonidine hydrochloride is the generic ingredient in six branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Tris Pharma Inc, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Dr Reddys Labs Sa, Endo Operations, Jubilant Generics, Novast Labs, Somerset Theraps Llc, Xiamen Lp Pharm Co, Concordia Pharms Inc, Boehringer Ingelheim, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Impax Labs, Interpharm, Par Pharm, Prinston Inc, Rising, Sun Pharm Inds Inc, Teva, Trupharma, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clonidine hydrochloride has twenty-one patent family members in fourteen countries.

There are thirteen drug master file entries for clonidine hydrochloride. Forty-five suppliers are listed for this compound.

Summary for CLONIDINE HYDROCHLORIDE
Recent Clinical Trials for CLONIDINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Universidad Simón BolívarPhase 3
National Cancer Institute, EgyptN/A
Sollis Therapeutics, Inc.Phase 3

See all CLONIDINE HYDROCHLORIDE clinical trials

Pharmacology for CLONIDINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CLONIDINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KAPVAY Extended-release Tablets clonidine hydrochloride 0.1 mg and 0.2 mg 022331 1 2011-03-04

US Patents and Regulatory Information for CLONIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms CLONIDINE HYDROCHLORIDE clonidine hydrochloride INJECTABLE;INJECTION 202601-002 Feb 20, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 070659-001 Jul 8, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic Pharms Ltd CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 091368-003 Dec 6, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 070397-001 Mar 23, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CLONIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-001 Sep 30, 2009 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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