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Generated: January 23, 2019

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Details for New Drug Application (NDA): 021312

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NDA 021312 describes CLARINEX, which is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from one supplier. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the CLARINEX profile page.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 021312
Tradename:CLARINEX
Applicant:Merck Sharp Dohme
Ingredient:desloratadine
Patents:2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Jun 26, 2002TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:Jul 14, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021312

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Accenture
Argus Health
Chubb
Fish and Richardson
Cipla
Express Scripts
Teva
McKesson

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