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, Difgen Pharms, 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, Trupharma, Unichem, 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:	6,340
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
Difgen Pharms	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	076157-003	Aug 18, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	078099-001	Aug 27, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202983-001	Apr 2, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070317-001	Jun 9, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210680-001	Apr 30, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	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-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	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-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	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
China	101400343	Modified release formulations containing drug-ion exchange resin complexes	⤷ Sign Up
Australia	2007227569	Modified release formulations containing drug-ion exchange resin complexes	⤷ Sign Up
Spain	2378573		⤷ Sign Up
Japan	2009530298		⤷ Sign Up
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА	⤷ Sign Up
Taiwan	200812649	Modified release formulations containing drug-ion exchange resin complexes	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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