Desloratadine - Generic Drug Details

What are the generic drug sources for desloratadine and what is the scope of freedom to operate?

Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Taro Pharm Inds Ltd, Organon, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orbion Pharms, Perrigo, Sandoz, Sun Pharm Inds, and Organon Llc, and is included in seventeen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desloratadine. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for desloratadine

US Patents:	2
Tradenames:	5
Applicants:	14
NDAs:	17
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	68
Patent Applications:	7,108
Drug Prices:	Drug price trends for desloratadine
What excipients (inactive ingredients) are in desloratadine?	desloratadine excipients list
DailyMed Link:	desloratadine at DailyMed

See drug prices for desloratadine

See drug sales revenues for desloratadine

Recent Clinical Trials for desloratadine

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
University of Victoria	N/A
J. Uriach and Company	Phase 1

See all desloratadine clinical trials

Generic filers with tentative approvals for DESLORATADINE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		5MG	TABLET; 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 desloratadine

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

Paragraph IV (Patent) Challenges for DESLORATADINE

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 desloratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	DESLORATADINE	desloratadine	TABLET;ORAL	078365-001	Mar 8, 2011	AB	RX	No	No
Lupin Pharms	DESLORATADINE	desloratadine	TABLET;ORAL	078352-001	Oct 25, 2010	AB	RX	No	No
Reddys	DESLORATADINE	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	078367-001	Jul 12, 2010		RX	No	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Perrigo	DESLORATADINE	desloratadine	TABLET;ORAL	078361-001	Dec 22, 2011		DISCN	No	No
Taro	DESLORATADINE	desloratadine	SOLUTION;ORAL	202936-001	May 26, 2016		DISCN	No	No
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 desloratadine

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	021312-001	Jun 26, 2002
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, 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

EU/EMA Drug Approvals for desloratadine

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