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Fexofenadine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fexofenadine hydrochloride?

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Dr Reddys Labs Ltd, Sciegen Pharms Inc, Sanofi Aventis Us, Actavis Mid Atlantic, Wockhardt Ltd, Aurolife Pharma Llc, Teva, Sun Pharm Inds, Barr, Mylan, Hetero Labs Ltd V, Sun Pharma Global, and Impax Pharms, and is included in twenty-five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-two patent family members in forty countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride. One hundred and three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: fexofenadine hydrochloride

Tradenames:13
Patents:8
Applicants:13
NDAs:25
Drug Master File Entries: see list23
Suppliers / Packagers: see list103
Bulk Api Vendors: see list60
Clinical Trials: see list1,000
Patent Applications: see list1,229
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fexofenadine hydrochloride at DailyMed

Pharmacology for Ingredient: fexofenadine hydrochloride

Tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL60/120MG
► Subscribe► SubscribeTABLET; ORAL30MG
► Subscribe► SubscribeTABLET; ORAL60MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds
FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL091567-006Feb 6, 2012OTCNoNo► Subscribe► Subscribe
Wockhardt Ltd
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL079112-001Feb 8, 2012OTCNoNo► Subscribe► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 2011OTCYesYes6,037,353*PED► SubscribeY► Subscribe
Barr
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride
CAPSULE;ORAL076169-001Jul 13, 2005DISCNNoNo► Subscribe► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 2011OTCYesYes6,723,348► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 20115,578,610► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 20116,399,632► Subscribe
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19966,399,632*PED► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 20115,738,872► Subscribe
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 20115,578,610*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fexofenadine 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
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient► 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

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9323047► Subscribe
Denmark1965768► Subscribe
Australia2006326551► Subscribe
Norway307688► Subscribe
South Korea101020809► 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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