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Generated: April 27, 2017

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Fexofenadine hydrochloride - Generic Drug Details

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What are the generic sources for fexofenadine hydrochloride and what is the scope of freedom to operate?

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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has seventy-two patent family members in forty countries.

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

Summary for Generic Name: fexofenadine hydrochloride

Drug Master File Entries: see list23
Suppliers / Packagers: see list104
Bulk Api Vendors: see list60
Clinical Trials: see list1,000
Patent Applications: see list1,963
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


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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
fexofenadine hydrochloride
TABLET;ORAL077081-001Apr 16, 2007ABRXNoNo► Subscribe► Subscribe
Sanofi Aventis Us
fexofenadine hydrochloride
TABLET;ORAL020872-007Jan 24, 2011OTCYesNo6,037,353*PED► SubscribeY► Subscribe
fexofenadine hydrochloride
TABLET;ORAL076191-002Aug 31, 2005ABRXNoNo► Subscribe► Subscribe
Actavis Mid Atlantic
fexofenadine hydrochloride
SUSPENSION;ORAL203330-002Nov 18, 2014OTCNoNo► Subscribe► Subscribe
Sanofi Aventis Us
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYesYes6,037,353*PED► SubscribeY► Subscribe
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