Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Colorcon
Mallinckrodt
McKesson
Merck

Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021150

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

« Back to Dashboard

NDA 021150 describes ZYRTEC-D 12 HOUR, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ZYRTEC-D 12 HOUR profile page.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 021150
Suppliers and Packaging for NDA: 021150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-728 50580-728-12 2 BLISTER PACK in 1 CARTON (50580-728-12) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-728 50580-728-24 4 BLISTER PACK in 1 CARTON (50580-728-24) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021150
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL cetirizine hydrochloride; pseudoephedrine hydrochloride 021150 2004-06-02

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Nov 9, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 13, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
Patent:  Start TrialPatent Expiration:Jun 10, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 10, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS

Expired US Patents for NDA 021150

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007   Start Trial   Start Trial
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007   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:

McKesson
Mallinckrodt
Boehringer Ingelheim
Baxter
Dow
AstraZeneca

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.