Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Moodys
Medtronic
Merck
Cipla
Chinese Patent Office
Express Scripts
Mallinckrodt
US Army

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022331

« Back to Dashboard

NDA 022331 describes KAPVAY, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the KAPVAY profile page.

The generic ingredient in KAPVAY is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
Summary for 022331
Tradename:KAPVAY
Applicant:Concordia Pharms Inc
Ingredient:clonidine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022331
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 022331
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331 NDA Concordia Pharmaceuticals Inc. 59212-658 N 59212-658-60
JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-776 N 66993-776-60

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 30, 2009TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 25, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG
Approval Date:Sep 28, 2010TE:AB1RLD:Yes

Expired US Patents for NDA 022331

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 ➤ Try a Free Trial ➤ Try a Free Trial
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-001 Sep 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-002 May 25, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Farmers Insurance
Express Scripts
Medtronic
Harvard Business School
Accenture
Federal Trade Commission
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.