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Last Updated: April 20, 2024

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 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 one 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:	101
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	78
Patent Applications:	2,629
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
⤷ Try a Trial	⤷ Try a Trial	60MG;120MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	60/120MG	TABLET, EXTENDED RELEASE; ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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
Wockhardt	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	079112-001	Feb 8, 2012		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wockhardt	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	079112-005	Feb 8, 2012		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wockhardt	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	079112-004	Feb 8, 2012		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	077081-004	Jul 21, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Ltd	FEXOFENADINE HYDROCHLORIDE	fexofenadine hydrochloride	TABLET;ORAL	076502-003	Apr 11, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Ltd	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202978-002	Jan 18, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granules	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	211075-002	Oct 18, 2019		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	SUSPENSION;ORAL	201373-001	Jan 24, 2011	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-009	Jan 24, 2011	⤷ Try a Trial	⤷ Try a Trial
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-006	Jan 24, 2011	⤷ Try a Trial	⤷ Try a Trial
>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
Norway	339877		⤷ Try a Trial
Jordan	2549	مستحضر معلق فيكسوفينادين (Fexofenadine suspension formulation)	⤷ Try a Trial
Russian Federation	2008128418	КОМПОЗИЦИЯ СУСПЕНЗИИ ФЕКСОФЕНАДИНА	⤷ Try a Trial
Dominican Republic	P2006000274	FORMULACIÓN DE SUSPENSIÓN DE FEXOFENADINA	⤷ Try a Trial
Taiwan	I377061		⤷ Try a Trial
Egypt	25866	Fexofenadine suspension formulation	⤷ Try a Trial
Costa Rica	9993	FORMULACIÓN DE SUSPENSIÓN DE FEXOFENADINA	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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 verification 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.