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Last Updated: November 4, 2024

Desloratadine - Generic Drug Details


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What are the generic drug sources for desloratadine and what is the scope of freedom to operate?

Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Organon, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, Sun Pharm Inds, and Organon Llc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desloratadine. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for desloratadine
Drug Prices for desloratadine

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Drug Sales Revenue Trends for desloratadine

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Recent Clinical Trials for desloratadine

Identify potential brand extensions & 505(b)(2) entrants

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

See all desloratadine clinical trials

Generic filers with tentative approvals for DESLORATADINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Lupin Pharms DESLORATADINE desloratadine TABLET;ORAL 078352-001 Oct 25, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orbion Pharms DESLORATADINE desloratadine TABLET;ORAL 078357-001 Feb 19, 2010 AB RX 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
>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 desloratadine

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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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