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Fexofenadine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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Fexofenadine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Sun Pharma Global, Barr, Dr Reddys Labs Ltd, and Impax Pharms, and is included in seven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and thirteen patent family members in thirty-four countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Tradenames:3
Patents:6
Applicants:5
NDAs:7
Drug Master File Entries: see list23
Suppliers / Packaging: see list16
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60/120MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60MG; 120MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60MG; 120MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,113,942*PED► subscribe ► subscribe
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,039,974► subscribeY ► subscribe
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL079043-002Jun 22, 2011OTCNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20117,138,524*PED► subscribe
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20116,399,632*PED► subscribe
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20117,135,571*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

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► subscribe
8,129,408Pharmaceutical composition for piperidinoalkanol compounds► subscribe
6,187,791 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 Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Taiwan570812► subscribe
Israel134771► subscribe
South Korea100405116► 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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