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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 two suppliers. There are nine 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. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for NDA: 021312

Merck Sharp Dohme
Therapeutic Class:Respiratory Tract Agents

Summary for product number 001

Approval Date:Jun 26, 2002TE:ABRLD:Yes
Patent:5,607,697*PEDPatent Expiration:Dec 7, 2015Product Flag?Substance Flag?Delist Request?
Patent:6,100,274*PEDPatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:7,618,649*PEDPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021312

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 20024,804,666*PED<subscribe>
Merck Sharp Dohme
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 20027,214,683*PED<subscribe>
Merck Sharp Dohme
TABLET, ORALLY DISINTEGRATING;ORAL021312-002Jul 14, 20054,659,716*PED<subscribe>
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