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Last Updated: March 28, 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 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, Dr Reddys Labs Sa, Jubilant Generics, Lupin Ltd, 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
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-002 May 25, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Warner Chilcott CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 072139-001 Jun 13, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209285-001 Oct 23, 2017 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Url Labs CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 070923-003 Sep 4, 1987 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Duramed Pharms Barr CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 071102-001 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 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
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-002 May 25, 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 KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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