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Profile for Tradename: KAPVAY

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Kapvay is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from one supplier.

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

Summary for Tradename: KAPVAY

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: KAPVAY

Clinical Trials for: KAPVAY

Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Status: Recruiting Condition: Healthy

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Status: Completed Condition: Healthy

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Status: Completed Condition: Hypertension

Intrathecal Clonidine in Cesarean Section May Lead to Worse Blood Gas Results in the Newborns
Status: Completed Condition: Pregnancy

Epidural Clonidine for Lumbosacral Radiculopathy
Status: Terminated Condition: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination
Status: Not yet recruiting Condition: Postoperative Pain

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients
Status: Not yet recruiting Condition: Delirium

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Status: Recruiting Condition: Labor Pain

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Status: Completed Condition: Hyperemesis Gravidarum

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia Pharms Inc
KAPVAY
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-003Sep 28, 2010RXYes<disabled><disabled>
Concordia Pharms Inc
KAPVAY
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-004Sep 28, 2010DISCNNo<disabled><disabled>
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Expired Patents for Tradename: 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;ORAL022331-003Sep 28, 20105,869,100<disabled>
Concordia Pharms Inc
KAPVAY
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-004Sep 28, 20105,869,100<disabled>
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Paragraph IV activity for: KAPVAY

Drugname Dosage Strength RLD Submissiondate
clonidine hydrochlorideExtended-release Tablets0.1 mg and 0.2 mgKapvay3/4/2011
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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