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Last Updated: October 1, 2020

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CLARITIN HIVES RELIEF Drug Profile

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Which patents cover Claritin Hives Relief, and when can generic versions of Claritin Hives Relief launch?

Claritin Hives Relief is a drug marketed by Bayer Healthcare Llc and is included in three NDAs.

The generic ingredient in CLARITIN HIVES RELIEF is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and nineteen suppliers are listed for this compound. Additional details are available on the loratadine profile page.

US ANDA Litigation and Generic Entry Outlook for Claritin Hives Relief

A generic version of CLARITIN HIVES RELIEF was approved as loratadine by PLD ACQUISITIONS LLC on January 21st, 2003.

  Start Trial

Drug patent expirations by year for CLARITIN HIVES RELIEF
Recent Clinical Trials for CLARITIN HIVES RELIEF

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
Rutgers, The State University of New JerseyEarly Phase 1
University of MichiganPhase 2

See all CLARITIN HIVES RELIEF clinical trials

Paragraph IV (Patent) Challenges for CLARITIN HIVES RELIEF
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN SYRUP;ORAL loratadine 020641
CLARITIN HIVES RELIEF SYRUP;ORAL loratadine 020641
CLARITIN TABLET;ORAL loratadine 019658
CLARITIN HIVES RELIEF TABLET;ORAL loratadine 019658

US Patents and Regulatory Information for CLARITIN HIVES RELIEF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc CLARITIN HIVES RELIEF loratadine SYRUP;ORAL 020641-003 Nov 19, 2003 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN HIVES RELIEF loratadine TABLET;ORAL 019658-003 Nov 19, 2003 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN HIVES RELIEF REDITAB loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-003 Nov 19, 2003 OTC Yes Yes   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

Supplementary Protection Certificates for CLARITIN HIVES RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 SPC/GB08/005 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
0152897 C00152897/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897 SPC/GB01/012 United Kingdom   Start Trial 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 08C0004 France   Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897 2001C/013 Belgium   Start Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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