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Last Updated: April 18, 2024

CLONIDINE - Generic Drug Details

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What are the generic drug 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
Aveva	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	076157-001	Aug 18, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anchen Pharms	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202983-001	Apr 2, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070886-001	Aug 31, 1988	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-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-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	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
South Korea	20080108520	MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES	⤷ Try a Trial
Austria	E536867		⤷ 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
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.