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Last Updated: December 5, 2022

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, Taro Pharm Inds Ltd, Organon, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orbion Pharms, Perrigo, Sandoz, Sun Pharm Inds, and Organon Llc, and is included in seventeen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desloratadine. Six 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
See Plans and PricingSee Plans and Pricing5MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET; 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
Dr Reddys Labs Ltd DESLORATADINE desloratadine TABLET;ORAL 078365-001 Mar 8, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Pharms DESLORATADINE desloratadine TABLET;ORAL 078352-001 Oct 25, 2010 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Reddys DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367-001 Jul 12, 2010 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo DESLORATADINE desloratadine TABLET;ORAL 078361-001 Dec 22, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro DESLORATADINE desloratadine SOLUTION;ORAL 202936-001 May 26, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
>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
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
Krka, d.d., Novo mesto Dasselta desloratadine EMEA/H/C/002310
Dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.
Authorised yes no no 2011-11-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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