You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021312


✉ Email this page to a colleague

« Back to Dashboard


NDA 021312 describes CLARINEX, which is a drug marketed by Merck Sharp Dohme, Organon, and Organon Llc, and is included in five NDAs. It is available from one supplier. Additional details are available on the CLARINEX profile page.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 021312
Tradename:CLARINEX
Applicant:Organon
Ingredient:desloratadine
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 26, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 14, 2005TE:RLD:Yes

Expired US Patents for NDA 021312

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 ⤷  Try a Trial ⤷  Try a Trial
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ⤷  Try a Trial ⤷  Try a 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

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 verification 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.