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Last Updated: December 12, 2019

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CLARITIN-D Drug Profile

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

Claritin-d is a drug marketed by Bayer Healthcare Llc and is included in two NDAs.

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

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

See drug sales revenues for CLARITIN-D

Recent Clinical Trials for CLARITIN-D

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

SponsorPhase
University of MichiganPhase 2
BayerPhase 4
EMSPhase 3

See all CLARITIN-D clinical trials

Recent Litigation for CLARITIN-D

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-06
Simonian v. Merck & Co., Inc.2010-02-25
SCHERING CORPORATION v. SANDOZ INC.2008-04-03

See all CLARITIN-D litigation

Paragraph IV (Patent) Challenges for CLARITIN-D
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN-D TABLET, EXTENDED RELEASE;ORAL loratadine; pseudoephedrine sulfate 019670

US Patents and Regulatory Information for CLARITIN-D

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-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 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

Expired US Patents for CLARITIN-D

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
McKesson
Merck
AstraZeneca
Medtronic

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