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ALLEGRA HIVES Drug Profile

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Allegra Hives is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug.

This drug has forty-nine patent family members in twenty-three countries.

The generic ingredient in ALLEGRA HIVES is fexofenadine hydrochloride. There are twenty-one drug master file entries for this compound. Ninety-six suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for Tradename: ALLEGRA HIVES

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: ALLEGRA HIVES

Clinical Trials for: ALLEGRA HIVES

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 2011OTCNo6,113,942*PED<disabled> <disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-009Jan 24, 2011OTCYes5,932,247*PED<disabled> <disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 2011OTCNo5,855,912*PED<disabled> <disabled>
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Expired Patents for Tradename: ALLEGRA HIVES

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 20115,932,247*PED<disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 20115,578,610*PED<disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 20116,113,942*PED<disabled>
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Non-Orange Book Patents for Tradename: ALLEGRA HIVES

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
5,738,872 Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
8,129,408Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
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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 HIVES

Country Document Number Estimated Expiration
Australia701042<disabled in preview>
Taiwan460284<disabled in preview>
Denmark0812195<disabled in preview>
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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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