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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021300

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NDA 021300 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 NDA: 021300

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

Pharmacology for NDA: 021300

Suppliers and Packaging for NDA: 021300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARINEX
desloratadine
SOLUTION;ORAL 021300 NDA Merck Sharp & Dohme Corp. 0085-1334 0085-1334-01 1 BOTTLE in 1 CARTON (0085-1334-01) > 473 mL in 1 BOTTLE
CLARINEX
desloratadine
SOLUTION;ORAL 021300 NDA Merck Sharp & Dohme Corp. 0085-1334 0085-1334-02 1 BOTTLE in 1 CARTON (0085-1334-02) > 118 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.5MG/ML
Approval Date:Sep 1, 2004TE:AARLD:Yes
Patent:► SubscribePatent Expiration:Dec 1, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021300

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Chubb
Accenture
Queensland Health
Teva
Fuji
Express Scripts
Daiichi Sankyo
Colorcon
US Department of Justice
McKinsey

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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