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Last Updated: June 25, 2021

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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 four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for desloratadine
International Patents:63
US Patents:4
Tradenames:5
Applicants:12
NDAs:17
Drug Master File Entries: 16
Finished Product Suppliers / Packagers: 7
Raw Ingredient (Bulk) Api Vendors: 117
Clinical Trials: 63
Patent Applications: 6,755
Drug Prices: Drug price trends for desloratadine
What excipients (inactive ingredients) are in desloratadine?desloratadine excipients list
DailyMed Link:desloratadine at DailyMed
Drug Prices for desloratadine

See drug prices for desloratadine

Drug Sales Revenue Trends for desloratadine

See drug sales revenues for desloratadine

Recent Clinical Trials for desloratadine

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

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

See all desloratadine clinical trials

Generic filers with tentative approvals for DESLORATADINE
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free5MGTABLET; ORAL
  Get Started Free  Get Started Free5MGTABLET; 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
Sun Pharm Inds DESLORATADINE desloratadine TABLET;ORAL 078359-001 Nov 16, 2010 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Lupin Pharms DESLORATADINE desloratadine TABLET;ORAL 078352-001 Oct 25, 2010 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Belcher Pharms DESLORATADINE desloratadine TABLET;ORAL 078355-001 Apr 19, 2012 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Reddys DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367-002 Jul 12, 2010 RX No Yes   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Mylan Pharms Inc DESLORATADINE desloratadine TABLET;ORAL 078351-001 Feb 10, 2012 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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 SOLUTION;ORAL 021300-001 Sep 1, 2004   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Get Started Free   Get Started Free
>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 122008000001 Germany   Get Started Free PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
0152897 SPC/GB01/012 United Kingdom   Get Started Free PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
1110543 318 Finland   Get Started Free
1110543 SZ 1/2008 Austria   Get Started Free PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
1110543 CA 2008 00010 Denmark   Get Started Free PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
1110543 08C0004 France   Get Started Free PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543 1/2008 Austria   Get Started Free PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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