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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Medtronic
Cipla
Daiichi Sankyo
Express Scripts
Moodys
Fish and Richardson
Merck
Covington
Healthtrust
Cerilliant

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021165

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NDA 021165 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. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for 021165

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 021165

Suppliers and Packaging for NDA: 021165

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARINEX desloratadine TABLET;ORAL 021165 NDA Merck Sharp & Dohme Corp. 0085-1264 0085-1264-02 500 TABLET, FILM COATED in 1 BOTTLE (0085-1264-02)
CLARINEX desloratadine TABLET;ORAL 021165 NDA Merck Sharp & Dohme Corp. 0085-1264 0085-1264-01 100 TABLET, FILM COATED in 1 BOTTLE (0085-1264-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 21, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021165

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
Merck Sharp DohmeCLARINEXdesloratadineTABLET;ORAL021165-001Dec 21, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Medtronic
McKesson
AstraZeneca
Federal Trade Commission
Daiichi Sankyo
Merck
Healthtrust
Fuji
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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