LORATADINE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details

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What are the generic sources for loratadine; pseudoephedrine sulfate and what is the scope of patent protection?

Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Bayer Healthcare Llc, Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-two suppliers are listed for this compound.

Summary for LORATADINE; PSEUDOEPHEDRINE SULFATE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	32
Clinical Trials:	6
DailyMed Link:	LORATADINE; PSEUDOEPHEDRINE SULFATE at DailyMed

Recent Clinical Trials for LORATADINE; PSEUDOEPHEDRINE SULFATE

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Sponsor	Phase
Bayer	Phase 1
Bayer	Phase 4
Azidus Brasil	Phase 3

See all LORATADINE; PSEUDOEPHEDRINE SULFATE clinical trials

Pharmacology for LORATADINE; PSEUDOEPHEDRINE SULFATE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for LORATADINE; PSEUDOEPHEDRINE SULFATE

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 LORATADINE; PSEUDOEPHEDRINE SULFATE

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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
Perrigo Pharma Intl	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076050-001	Jan 30, 2003		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076557-001	Sep 22, 2004		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	218017-001	May 14, 2024		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 LORATADINE; PSEUDOEPHEDRINE SULFATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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