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Last Updated: August 10, 2020

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

Desloratadine has seventy-three patent family members in thirty-seven countries.

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
Xiangya Hospital of Central South UniversityPhase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
Johns Hopkins UniversityPhase 4

See all desloratadine clinical trials

Generic filers with tentative approvals for DESLORATADINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET; ORAL
  Start Trial  Start Trial5MGTABLET; 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 NDA Submissiondate
CLARINEX SOLUTION;ORAL desloratadine 021300 2008-05-08
CLARINEX TABLET;ORAL desloratadine 021165 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
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Dr Reddys Labs Ltd DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 078366-001 Apr 26, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd DESLORATADINE desloratadine TABLET;ORAL 078365-001 Mar 8, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>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
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for desloratadine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 08C0004 France   Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543 C 2008 001 Romania   Start Trial 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   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
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Medtronic
Harvard Business School
McKesson

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