CLARINEX Drug Patent Profile

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Clarinex is a drug marketed by Merck Sharp Dohme, Organon, and Organon Llc. and is included in five NDAs.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	19
Patent Applications:	4,322
Drug Prices:	Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?	CLARINEX excipients list
DailyMed Link:	CLARINEX at DailyMed

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

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLARINEX	Oral Solution	desloratadine	0.5 mg/mL	021300	1	2008-05-08
CLARINEX	Orally Disintegrating Tablets	desloratadine	2.5 mg and 5 mg	021165	3	2006-06-21

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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
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	⤷ Try a Trial	⤷ Try a Trial
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	⤷ Try a Trial	⤷ Try a Trial
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	⤷ Try a Trial	⤷ Try a Trial
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Actavis Group PTC ehf	Desloratadine Actavis	desloratadine	EMEA/H/C/002435 Treatment of allergic rhinitis and urticaria.	Authorised	yes	no	no	2012-01-13
N.V. Organon	Azomyr	desloratadine	EMEA/H/C/000310 Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1)	Authorised	no	no	no	2001-01-15
Ratiopharm GmbH	Desloratadine ratiopharm	desloratadine	EMEA/H/C/002404 Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician	Authorised	yes	no	no	2012-01-13
N.V. Organon	Aerius	desloratadine	EMEA/H/C/000313 Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	no	no	no	2001-01-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

See the table below for patents covering CLARINEX around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	0005938		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	0156574		⤷ Try a Trial
Australia	600665		⤷ Try a Trial
Hungary	199138	PROCESS FOR PRODUCING AZA DERIVATIVES OF DIHYDRO-DIBENZO /A,D/CYCLOHEPTENES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE NEW DERIVATIVE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	1/2008	Austria	⤷ Try a Trial	PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	91403	Luxembourg	⤷ Try a Trial	91403, EXPIRES: 20220730
1110543	318	Finland	⤷ Try a Trial
0152897	C00152897/01	Switzerland	⤷ Try a Trial	FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description