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Last Updated: November 4, 2024

CLARINEX Drug Patent Profile


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Summary for CLARINEX
Drug patent expirations by year for CLARINEX
Drug Prices for CLARINEX

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Drug Sales Revenue Trends for CLARINEX

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Recent Clinical Trials for CLARINEX

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SponsorPhase
J. Uriach and CompanyPhase 1
Derm Research, PLLCPhase 4
UCB PharmaPhase 4

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Pharmacology for CLARINEX
Paragraph IV (Patent) Challenges for CLARINEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CLARINEX Oral Solution desloratadine 0.5 mg/mL 021300 1 2008-05-08
CLARINEX Orally Disintegrating Tablets desloratadine 2.5 mg and 5 mg 021165 3 2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 ⤷  Sign Up ⤷  Sign Up
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 ⤷  Sign Up ⤷  Sign Up
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CLARINEX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Actavis Group PTC ehf Desloratadine Actavis desloratadine EMEA/H/C/002435
Treatment of allergic rhinitis and urticaria.
Authorised yes no no 2012-01-13
N.V. Organon Azomyr desloratadine EMEA/H/C/000310
Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1)
Authorised no no no 2001-01-15
Ratiopharm GmbH Desloratadine ratiopharm desloratadine EMEA/H/C/002404
Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician
Authorised yes no no 2012-01-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CLARINEX

See the table below for patents covering CLARINEX around the world.

Country Patent Number Title Estimated Expiration
New Zealand 222253 6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H-BENZO C5,6,)CYCLOHEPTA C1,2-B)PYRIDINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
Spain 2097155 ⤷  Sign Up
China 1935141 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLARINEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 SZ 1/2008 Austria ⤷  Sign Up PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
1110543 C 2008 001 Romania ⤷  Sign Up PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
1110543 318 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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. 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.