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 six branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Tris Pharma Inc, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Dr Reddys Labs Sa, 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 fifty-eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are thirteen drug master file entries for clonidine hydrochloride. Forty-four suppliers are listed for this compound.

Summary for CLONIDINE HYDROCHLORIDE

International Patents:	21
US Patents:	2
Tradenames:	6
Applicants:	36
NDAs:	58
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	378
Patent Applications:	2,901
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLONIDINE HYDROCHLORIDE
What excipients (inactive ingredients) are in CLONIDINE HYDROCHLORIDE?	CLONIDINE HYDROCHLORIDE excipients list
DailyMed Link:	CLONIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CLONIDINE HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Pharmacology for CLONIDINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes 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

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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
Unichem	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	078895-002	Aug 26, 2009	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
Actavis Elizabeth	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203320-001	May 15, 2015	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	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 HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010	⤷ Sign Up	⤷ Sign Up
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-001	Sep 30, 2009	⤷ Sign Up	⤷ Sign Up
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CLONIDINE HYDROCHLORIDE

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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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