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ALLEGRA Drug Profile

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Allegra is a drug marketed by Sanofi Aventis Us and is included in five NDAs. It is available from one supplier. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in ALLEGRA is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for Tradename: ALLEGRA

Patents:5
Applicants:1
NDAs:5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list43
Clinical Trials: see list15
Patent Applications: see list5,402
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ALLEGRA at DailyMed

Pharmacology for Tradename: ALLEGRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 1996DISCNNoNo6,037,353*PED► subscribeY► subscribe
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYesYes6,039,974► subscribeY ► subscribe
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYesYes6,037,353*PED► subscribeY► subscribe
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Expired Patents for Tradename: ALLEGRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20067,138,524*PED► subscribe
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19964,254,129► subscribe
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19965,855,912*PED► subscribe
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Paragraph IV activity for: ALLEGRA

Drugname Dosage Strength RLD Submissiondate
fexofenadine hydrochlorideOral Suspension30 mg/5 mLAllegra1/25/2010
fexofenadine hydrochloride and pseudoephedrine hydrochlorideExtended-release Tablets180 mg/240 mgAllegra-D 24 Hour6/6/2007

Non-Orange Book Patents for Tradename: ALLEGRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient► subscribe
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ALLEGRA

Country Document Number Estimated Expiration
Mexico9302704► subscribe
JapanH07506828► subscribe
Denmark0639976► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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