CLARITIN-D Drug Patent Profile

When do Claritin-d patents expire, and when can generic versions of Claritin-d launch?

Claritin-d is a drug marketed by Bayer Healthcare Llc and is included in two NDAs.

The generic ingredient in CLARITIN-D is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Claritin-d

A generic version of CLARITIN-D was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30^th, 2003.

Summary for CLARITIN-D

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	27
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for CLARITIN-D
What excipients (inactive ingredients) are in CLARITIN-D?	CLARITIN-D excipients list
DailyMed Link:	CLARITIN-D at DailyMed

See drug sales revenues for CLARITIN-D

Recent Clinical Trials for CLARITIN-D

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Rutgers, The State University of New Jersey	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CLARITIN-D clinical trials

Pharmacology for CLARITIN-D

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

Anatomical Therapeutic Chemical (ATC) Classes for CLARITIN-D

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 CLARITIN-D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002		OTC	Yes	Yes

Expired US Patents for CLARITIN-D

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
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002

International Patents for CLARITIN-D

See the table below for patents covering CLARITIN-D around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	94387	NOVEL ANTHISTAMINES,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Ireland	51303	NOVEL ANTIHISTAMINES
Denmark	469485
Philippines	25101	8-AND/OR 9-SUBSTITUTED-6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H BENZO (5,6) CYCLOHEPTA (1,2-B) PYRIDINES AND THEIR SALTS PHARMACEUTICAL COMPOSITIONS CONTAINING THEIR AND METHODS FOR TREATING ALLERGIC REACTIONS
South Korea	850000744
Hong Kong	75993	PROCESS FOR PREPARING PIPERIDYLIDENE DIHYDRODIBENZO(A,D)CYCLOHEPTENES AND AZA DERIVATIVES THEREOF,COMPOUNDS OBTAINED BY SUCH PROCESS AND THE USE OF SUCH COMPOUNDS FOR PREPARING USEFUL PHARMACEUTICAL COMPOSITIONS
Singapore	70587

Supplementary Protection Certificates for CLARITIN-D

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0152897	SPC/GB01/012	United Kingdom		PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH