Fexofenadine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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

Fexofenadine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Chattem Sanofi, Aurobindo Pharma, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharm, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for fexofenadine hydrochloride; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	9
Finished Product Suppliers / Packagers:	28
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fexofenadine hydrochloride; pseudoephedrine hydrochloride
DailyMed Link:	fexofenadine hydrochloride; pseudoephedrine hydrochloride at DailyMed

Recent Clinical Trials for fexofenadine hydrochloride; pseudoephedrine hydrochloride

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

Sponsor	Phase
Sanofi	Phase 4
Sanofi	Phase 3
Dr. Reddy's Laboratories Limited	Phase 1

See all fexofenadine hydrochloride; pseudoephedrine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		60MG;120MG	TABLET, EXTENDED RELEASE;ORAL
		60/120MG	TABLET, EXTENDED RELEASE; ORAL
		60MG; 120MG	TABLET, EXTENDED RELEASE; 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; pseudoephedrine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for fexofenadine hydrochloride; pseudoephedrine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for fexofenadine hydrochloride; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090818-001	Jan 29, 2015		OTC	No	No
Dr Reddys	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	215434-001	May 31, 2022		OTC	No	No
Impax Pharms	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076298-001	Nov 12, 2010		DISCN	No	No
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011		OTC	Yes	Yes
Aurobindo Pharma	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209116-001	Oct 30, 2017		OTC	No	No
Barr	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076236-001	Apr 14, 2005		DISCN	No	No

Expired US Patents for fexofenadine hydrochloride; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011