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Last Updated: April 24, 2024

Clonidine - Generic Drug Details

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

Clonidine is the generic ingredient in ten branded drugs marketed by Tris Pharma Inc, Lavipharm, Actavis Labs Ut Inc, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Athena, 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, 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 sixty-four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are twenty-two drug master file entries for clonidine. Eight suppliers are listed for this compound.

Summary for clonidine

International Patents:	21
US Patents:	2
Tradenames:	10
Applicants:	41
NDAs:	64
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	372
Patent Applications:	5,931
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for clonidine
Drug Sales Revenues:	Drug sales revenues for clonidine
What excipients (inactive ingredients) are in clonidine?	clonidine excipients list
DailyMed Link:	clonidine at DailyMed

See drug prices for clonidine

See drug sales revenues for clonidine

Recent Clinical Trials for clonidine

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

Sponsor	Phase
National Cancer Institute, Egypt	N/A
Sollis Therapeutics, Inc.	Phase 3
Loyola University	Phase 4

See all clonidine clinical trials

Pharmacology for clonidine

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for clonidine

Adrenergic alpha-2 Receptor Agonists
Analgesics
Antihypertensive Agents
Sympatholytics

US Patents and Regulatory Information for clonidine

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Glossary

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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	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070396-001	Mar 23, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Prinston Inc	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	077901-002	Mar 9, 2007	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Institutional	DURACLON	clonidine hydrochloride	INJECTABLE;INJECTION	020615-001	Oct 2, 1996	AP	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Farmaceutica	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300-002	Jan 26, 2011	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	079090-003	Aug 20, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Labs Ut Inc	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	090873-003	May 6, 2014	AB	RX	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for clonidine

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА	⤷ Try a Trial
Denmark	2018160		⤷ Try a Trial
Canada	2645855	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)	⤷ Try a Trial
Denmark	2428205		⤷ Try a Trial
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)	⤷ Try a Trial
Australia	2007227569	Modified release formulations containing drug-ion exchange resin complexes	⤷ Try a Trial
Taiwan	200812649	Modified release formulations containing drug-ion exchange resin complexes	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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