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Last Updated: November 24, 2024

DESLORATADINE Drug Patent Profile


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When do Desloratadine patents expire, and when can generic versions of Desloratadine launch?

Desloratadine is a drug marketed by Taro, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, and Sun Pharm Inds. and is included in twelve NDAs.

The generic ingredient in DESLORATADINE 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.

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Drug patent expirations by year for DESLORATADINE
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Drug Sales Revenue Trends for DESLORATADINE

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Recent Clinical Trials for DESLORATADINE

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SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
University of VictoriaN/A
J. Uriach and CompanyPhase 1

See all DESLORATADINE clinical trials

Pharmacology for DESLORATADINE
Paragraph IV (Patent) Challenges for DESLORATADINE
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 DESLORATADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro DESLORATADINE desloratadine SOLUTION;ORAL 202592-001 Jun 30, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dash Pharms DESLORATADINE desloratadine TABLET;ORAL 078351-001 Feb 10, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Reddys DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367-002 Jul 12, 2010 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds DESLORATADINE desloratadine TABLET;ORAL 078359-001 Nov 16, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd DESLORATADINE desloratadine TABLET;ORAL 078365-001 Mar 8, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro DESLORATADINE desloratadine SOLUTION;ORAL 202936-001 May 26, 2016 DISCN No 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

EU/EMA Drug Approvals for DESLORATADINE

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
N.V. Organon Aerius desloratadine EMEA/H/C/000313
Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.
Authorised no no no 2001-01-15
N.V. Organon Neoclarityn desloratadine EMEA/H/C/000314
Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria
Authorised no no no 2001-01-15
Teva B.V Desloratadine Teva desloratadine EMEA/H/C/002419
Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.
Authorised yes no no 2011-11-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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