Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
McKinsey
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022331

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« 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-three 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
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 59212-658-60 1 BOTTLE in 1 CARTON (59212-658-60) > 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331 NDA Concordia Pharmaceuticals Inc. 59212-658 59212-658-60 1 BOTTLE in 1 CARTON (59212-658-60) > 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022331
Tradename Dosage Ingredient NDA Submissiondate
KAPVAY TABLET, EXTENDED RELEASE;ORAL clonidine hydrochloride 022331 2011-03-04
JENLOGA TABLET, EXTENDED RELEASE;ORAL clonidine hydrochloride 022331 2011-03-04

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EXTENDED RELEASE;ORALStrength0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-001 Sep 30, 2009   Start Trial   Start Trial
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010   Start Trial   Start Trial
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-003 Sep 28, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Express Scripts
McKinsey
Moodys
Baxter

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.