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Last Updated: July 13, 2020

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CLARITIN Drug Profile


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

Claritin is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs.

The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Drug patent expirations by year for CLARITIN
Drug Sales Revenue Trends for CLARITIN

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Recent Clinical Trials for CLARITIN

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

See all CLARITIN clinical trials

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

US Patents and Regulatory Information for CLARITIN

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 loratadine CAPSULE;ORAL 021952-001 Jun 16, 2008 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
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021993-001 Dec 12, 2006 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine TABLET, CHEWABLE;ORAL 021891-002 Nov 21, 2018 OTC Yes 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 CLARITIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLARITIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0152897 C00152897/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
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 2001C/013 Belgium   Start Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Harvard Business School
Baxter
AstraZeneca
Medtronic

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