FEXOFENADINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Fexofenadine Hydrochloride, and what generic alternatives are available?

Fexofenadine Hydrochloride is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm. and is included in twenty-two NDAs.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fexofenadine Hydrochloride

A generic version of FEXOFENADINE HYDROCHLORIDE was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22^nd, 2011.

Summary for FEXOFENADINE HYDROCHLORIDE

US Patents:	0
Applicants:	17
NDAs:	22
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	79
Patent Applications:	1,698
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
Bristol-Myers Squibb	Phase 1
Dhaka Medical College	Phase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi Company	Phase 3

See all FEXOFENADINE HYDROCHLORIDE clinical trials

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079043-002	Jun 22, 2011		OTC	No	No
Teva	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	076447-006	Apr 13, 2011		OTC	No	No
Sciegen Pharms Inc	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	204507-005	Sep 16, 2015		OTC	No	No
Dr Reddys Labs Ltd	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	076502-009	Apr 12, 2011		OTC	No	No
Sun Pharm Inds	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	091567-003	Feb 6, 2012		DISCN	No	No