Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020470

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NDA 020470 describes CLARITIN-D 24 HOUR, which is a drug marketed by Bayer Healthcare Llc and is included in one NDA. It is available from one supplier. Additional details are available on the CLARITIN-D 24 HOUR profile page.

The generic ingredient in CLARITIN-D 24 HOUR 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.
Summary for 020470
Suppliers and Packaging for NDA: 020470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470 NDA Bayer HealthCare LLC. 11523-4332 11523-4332-1 1 BLISTER PACK in 1 CARTON (11523-4332-1) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470 NDA Bayer HealthCare LLC. 11523-4332 11523-4332-2 1 BLISTER PACK in 1 CARTON (11523-4332-2) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 020470
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN-D 24 HOUR TABLET, EXTENDED RELEASE;ORAL loratadine; pseudoephedrine sulfate 020470

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG;240MG
Approval Date:Nov 27, 2002TE:RLD:Yes

Expired US Patents for NDA 020470

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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