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 eleven 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, Chartwell Rx, 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, Unichem, Url Labs, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in sixty-five NDAs. There are four 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:	4
Tradenames:	11
Applicants:	41
NDAs:	65
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	378
Patent Applications:	5,997
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
Universidad Simón Bolívar	Phase 3
National Cancer Institute, Egypt	N/A
Sollis Therapeutics, Inc.	Phase 3

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

Anatomical Therapeutic Chemical (ATC) Classes for clonidine

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
Impax Labs	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	078099-003	Aug 27, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Technologies	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	076166-001	Jul 16, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Technologies	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	076166-003	Jul 16, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tris Pharma Inc	ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645-001	May 24, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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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	⤷ Sign Up	⤷ Sign Up
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	⤷ Sign Up	⤷ Sign Up
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	⤷ Sign Up	⤷ Sign Up
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	⤷ Sign Up	⤷ Sign Up
>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
Denmark	2428205		⤷ Sign Up
Japan	5479086		⤷ Sign Up
China	101400343	Modified release formulations containing drug-ion exchange resin complexes	⤷ Sign Up
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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