KAPVAY Drug Patent Profile

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When do Kapvay patents expire, and what generic alternatives are available?

Kapvay is a drug marketed by Concordia Pharms Inc and is included in one NDA.

The generic ingredient in KAPVAY is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kapvay

A generic version of KAPVAY was approved as clonidine hydrochloride by ACTAVIS ELIZABETH on December 16^th, 1986.

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Summary for KAPVAY

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	6
Patent Applications:	1,871
Drug Prices:	Drug price information for KAPVAY
What excipients (inactive ingredients) are in KAPVAY?	KAPVAY excipients list
DailyMed Link:	KAPVAY at DailyMed

Drug patent expirations by year for KAPVAY

Recent Clinical Trials for KAPVAY

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

Sponsor	Phase
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4
Children's Hospital of Pittsburgh	N/A

See all KAPVAY clinical trials

Paragraph IV (Patent) Challenges for KAPVAY

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 KAPVAY

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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	⤷ 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 KAPVAY

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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	022331-003	Sep 28, 2010	⤷ Sign Up	⤷ Sign Up
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for KAPVAY

See the table below for patents covering KAPVAY around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9622768		⤷ Sign Up
Australia	707843		⤷ Sign Up
European Patent Office	0805677	PREPARATION DE CLONIDINE A LIBERATION PROLONGEE (EXTENDED RELEASE CLONIDINE FORMULATION)	⤷ Sign Up
Canada	2211325	PREPARATION DE CLONIDINE A LIBERATION PROLONGEE (EXTENDED RELEASE CLONIDINE FORMULATION)	⤷ Sign Up
Australia	5259396		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for KAPVAY

Recent Clinical Trials for KAPVAY

Paragraph IV (Patent) Challenges for KAPVAY

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