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Serving leading biopharmaceutical companies globally:

Argus Health
Fuji
Daiichi Sankyo
Johnson and Johnson
Julphar
Fish and Richardson
Covington
Teva
Express Scripts
McKinsey

Generated: January 16, 2018

DrugPatentWatch Database Preview

ALLEGRA Drug Profile

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Which patents cover Allegra, and what generic alternatives are available?

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

This drug has seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Drug patent expirations by year for ALLEGRA
Pharmacology for ALLEGRA

US Patents and Regulatory Information for ALLEGRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ALLEGRA fexofenadine hydrochloride CAPSULE;ORAL 020625-001 Jul 25, 1996 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-010 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA fexofenadine hydrochloride SUSPENSION;ORAL 021963-001 Oct 16, 2006 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-009 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-008 Jan 24, 2011 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ALLEGRA

Paragraph IV (Patent) Challenges for ALLEGRA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Oral Suspension 30 mg/5 mL ➤ Subscribe 1/25/2010
➤ Subscribe Extended-release Tablets 180 mg/240 mg ➤ Subscribe 6/6/2007

Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for ALLEGRA

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Serving leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
US Department of Justice
AstraZeneca
Chubb
Julphar
Healthtrust
Fuji
Queensland Health

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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