FEXOFENADINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for fexofenadine hydrochloride and what is the scope of patent protection?

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Chattem Sanofi, Barr, P And L, Taro, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Wockhardt, L Perrigo Co, Granules, Sciegen Pharms Inc, Unique, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has forty-three patent family members in thirty-eight countries.

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

Summary for FEXOFENADINE HYDROCHLORIDE

International Patents:	43
US Patents:	1
Tradenames:	13
Applicants:	19
NDAs:	32
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	102
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	78
Patent Applications:	2,621
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in FEXOFENADINE HYDROCHLORIDE?	FEXOFENADINE HYDROCHLORIDE excipients list
DailyMed Link:	FEXOFENADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dhaka Medical College	Phase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi Company	Phase 3
Eurofarma Laboratorios S.A.	Phase 3

See all FEXOFENADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	60MG;120MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	60/120MG	TABLET, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	180MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FEXOFENADINE HYDROCHLORIDE

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FEXOFENADINE HYDROCHLORIDE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHILDREN'S ALLEGRA HIVES	Oral Suspension (OTC)	fexofenadine hydrochloride	30 mg/5 mL	201373	1	2010-01-25

US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	211075-001	Oct 18, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	FEXOFENADINE HYDROCHLORIDE	fexofenadine hydrochloride	CAPSULE;ORAL	076169-001	Jul 13, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	079112-001	Feb 8, 2012		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	076447-007	Apr 13, 2011		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	076447-005	Apr 13, 2011		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FEXOFENADINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-003	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	SUSPENSION;ORAL	201373-001	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FEXOFENADINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Austria	E431137		⤷ Sign Up
Norway	339877		⤷ Sign Up
Norway	20082904		⤷ Sign Up
South Africa	200803985	Fexofenadine suspension formulation	⤷ Sign Up
Costa Rica	9993	FORMULACIÓN DE SUSPENSIÓN DE FEXOFENADINA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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