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Last Updated: April 20, 2024

Clonidine hydrochloride - Generic Drug Details


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What are the generic sources for clonidine hydrochloride and what is the scope of patent protection?

Clonidine hydrochloride is the generic ingredient in five branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Anchen Pharms, Bluepharma Industria, Chartwell Rx, Dr Reddys Labs Sa, Jubilant Generics, Novast Labs, 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, Unichem, Url Labs, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for clonidine hydrochloride. Forty 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
National Cancer Institute, EgyptN/A
Sollis Therapeutics, Inc.Phase 3
Loyola UniversityPhase 4

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
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unichem CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895-003 Aug 26, 2009 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 077901-003 Mar 9, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 210680-001 Apr 30, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic Pharms Ltd CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 091368-001 Dec 6, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202792-002 May 15, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Duramed Pharms Barr CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 071101-001 Aug 14, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-003 Sep 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-001 Sep 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim CATAPRES clonidine hydrochloride TABLET;ORAL 017407-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-002 May 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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