CLARINEX Drug Patent Profile

When do Clarinex patents expire, and when can generic versions of Clarinex launch?

Clarinex is a drug marketed by Merck Sharp Dohme and Organon and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

DrugPatentWatch^® Generic Entry Outlook for Clarinex

Clarinex was eligible for patent challenges on December 21, 2005.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for CLARINEX

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	19
Patent Applications:	4,776
Drug Prices:	Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?	CLARINEX excipients list
DailyMed Link:	CLARINEX at DailyMed

See drug prices for CLARINEX

See drug sales revenues for CLARINEX

Recent Clinical Trials for CLARINEX

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

Sponsor	Phase
J. Uriach and Company	Phase 1
Derm Research, PLLC	Phase 4
UCB Pharma	Phase 4

See all CLARINEX clinical trials

Pharmacology for CLARINEX

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

Anatomical Therapeutic Chemical (ATC) Classes for CLARINEX

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

Paragraph IV (Patent) Challenges for CLARINEX

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

US Patents and Regulatory Information for CLARINEX

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
Organon	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No					Y
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No			Y

Expired US Patents for CLARINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002

EU/EMA Drug Approvals for CLARINEX

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
N.V. Organon	Neoclarityn	desloratadine	EMEA/H/C/000314 Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria	Authorised	no	no	no	2001-01-15
Teva B.V	Desloratadine Teva	desloratadine	EMEA/H/C/002419 Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	yes	no	no	2011-11-24
Krka, d.d., Novo mesto	Dasselta	desloratadine	EMEA/H/C/002310 Dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	yes	no	no	2011-11-28

International Patents for CLARINEX

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	9702026
Netherlands	300042
Hungary	T77315
Saudi Arabia	1490	تركيبة جرعة تؤخذ بالفم ممتدة الانطلاق (EXTENDED RELEASE ORAL DOSAGE COMPOSITION)
New Zealand	300398	Pharmaceutical uses of the pyridine derivative descarboethoxyloratadine (DCL)
Egypt	23908	Stabilized antihistamine syrup
Guatemala	199900072	JARABE ANTIHISTAMINICO ESTABILIZADO.

Supplementary Protection Certificates for CLARINEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	CA 2008 00010	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
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	300328	Netherlands
1110543	318	Finland
1110543	SZ 1/2008	Austria		PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.