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Details for New Drug Application (NDA): 020872

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NDA 020872 describes CHILDREN'S ALLEGRA HIVES, which is a drug marketed by Sanofi Aventis Us and is included in three NDAs. It is available from seven suppliers. There are four patents protecting this drug. Additional details are available on the CHILDREN'S ALLEGRA HIVES profile page.

The generic ingredient in CHILDREN'S ALLEGRA HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for NDA: 020872

Tradename:
4
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020872

Suppliers and Packaging for NDA: 020872

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 020872 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5619 0615-5619-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-5619-39)
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL 020872 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5620 0615-5620-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-5620-39)

Summary for product number 005

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:6,037,353*PEDPatent Expiration:Sep 14, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 006

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:6,037,353*PEDPatent Expiration:Sep 14, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 007

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:6,037,353*PEDPatent Expiration:Sep 14, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020872

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 20117,138,524*PED► Subscribe
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 20117,135,571*PED► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 20115,855,912*PED► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-005Jan 24, 20115,855,912*PED► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 20117,138,524*PED► Subscribe
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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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