CLARINEX D 24 HOUR Drug Patent Profile

Which patents cover Clarinex D 24 Hour, and what generic alternatives are available?

Clarinex D 24 Hour is a drug marketed by Organon and is included in one NDA.

The generic ingredient in CLARINEX D 24 HOUR 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.

Summary for CLARINEX D 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	19
Patent Applications:	6
DailyMed Link:	CLARINEX D 24 HOUR at DailyMed

Recent Clinical Trials for CLARINEX D 24 HOUR

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 D 24 HOUR clinical trials

US Patents and Regulatory Information for CLARINEX D 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No

Expired US Patents for CLARINEX D 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,820,199*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	4,659,716*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,618,649*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,214,684*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,214,683*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	6,100,274*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	6,979,463

International Patents for CLARINEX D 24 HOUR

See the table below for patents covering CLARINEX D 24 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	140450
Hungary	0004988
Slovenia	1110543
Philippines	23821	AN IMPROVED PROCESS FOR THE PREPARATION OF PIPERIDYLIDENE DIHYDROBENZO(A,D)CYCLOHEPTENES AND AZADERIVATIVES THEREOF
Portugal	1112738
Hong Kong	1090840
New Zealand	509028	Stable extended release oral dosage composition comprising a pseudoephedrine-containing core, the core being uniformly covered with a desloratadine-containing film

Supplementary Protection Certificates for CLARINEX D 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	C 2008 001	Romania		PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
1110543	122008000001	Germany		PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
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.
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
1110543	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; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	SPC063/2007	Ireland		SPC063/2007: 20081105, EXPIRES: 20220729
1110543	91403	Luxembourg		91403, EXPIRES: 20220730

CLARINEX D 24 HOUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clarinex-D 24 Hour

Introduction

Clarinex-D 24 Hour, a combination of the antihistamine desloratadine and the decongestant pseudoephedrine sulfate, is a significant player in the allergy treatment market. This article delves into the market dynamics and financial trajectory of this medication.

Market Approval and Launch

Clarinex-D 24 Hour was approved by the FDA on March 3, 2005, for the relief of symptoms associated with seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older[4].

Market Positioning

The drug is part of Schering-Plough's (now part of Merck & Co.) extensive allergy treatment portfolio, which includes other successful products like Claritin and Nasonex. Clarinex-D 24 Hour was positioned as a once-daily treatment option that combines the antihistaminic properties of desloratadine with the decongestant properties of pseudoephedrine, offering 24-hour relief from both nasal and non-nasal symptoms of seasonal allergic rhinitis[1][4].

Competitive Landscape

In the allergy treatment market, Clarinex-D 24 Hour competes with other antihistamine and decongestant combinations. However, its unique once-daily dosing and non-sedating properties have helped it stand out. The introduction of a 12-hour formulation, Clarinex-D 12 Hour, in 2006 further expanded the treatment options available to patients and healthcare providers[5].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy of Clarinex-D 24 Hour in relieving symptoms of seasonal allergic rhinitis. The drug has shown significant improvement in total symptom scores compared to pseudoephedrine alone and desloratadine alone. Common adverse reactions include dry mouth, headache, insomnia, fatigue, and somnolence, but these are generally well-tolerated[1][5].

Financial Performance

The financial success of Clarinex-D 24 Hour is closely tied to the overall performance of Schering-Plough's allergy treatment segment. In 2000, Schering-Plough reported significant growth in its pharmaceutical sales, with the Claritin franchise being a major contributor. The introduction of Clarinex (desloratadine) and its combination products like Clarinex-D further bolstered the company's position in the allergy market. Worldwide sales of Claritin increased by 13% to $3.0 billion in 2000, and the company expected Clarinex to build on this success[2].

Revenue Impact

While specific revenue figures for Clarinex-D 24 Hour are not separately reported, the drug's approval and market performance contributed to Schering-Plough's overall revenue growth. In 2005, the year following the FDA approval of Clarinex-D 24 Hour, Schering-Plough's net income totaled $2.4 billion, with pharmaceutical sales growing by 8% to $9.8 billion[2].

Generic Competition

As of the latest updates, there is no therapeutically equivalent generic version of Clarinex-D 24 Hour available in the United States. This lack of generic competition has helped maintain the drug's market share and revenue[3].

Market Expansion and Future Outlook

Schering-Plough's strategy to expand its global allergy/respiratory franchise included gaining marketing approvals for various products, including Clarinex-D 24 Hour. The company's efforts to tailor treatment regimens based on patients' specific symptoms and needs have been successful, as evidenced by the approval and market acceptance of both the 12-hour and 24-hour formulations of Clarinex-D[5].

Regulatory and Safety Considerations

The use of Clarinex-D 24 Hour is subject to certain precautions, particularly regarding cardiovascular and central nervous system effects due to the pseudoephedrine component. It should be used with caution in patients with cardiovascular disorders and not used in patients with severe hypertension or severe coronary artery disease. Additionally, it should not be used with MAO inhibitors due to the risk of hypertensive crisis[1].

Consumer and Physician Acceptance

Clarinex-D 24 Hour has been well-received by both patients and healthcare providers. Physicians appreciate the flexibility of having both 12-hour and 24-hour formulations to tailor treatment to individual patient needs. Patients benefit from the effective relief of nasal congestion and other allergy symptoms without the sedating effects common in other antihistamines[5].

Key Takeaways

• Market Approval: Clarinex-D 24 Hour was FDA-approved in 2005 for seasonal allergic rhinitis.
• Clinical Efficacy: The drug combines desloratadine and pseudoephedrine for 24-hour relief from nasal and non-nasal symptoms.
• Financial Performance: Contributed to Schering-Plough's revenue growth in the allergy treatment segment.
• Competitive Advantage: Lack of generic competition and unique once-daily dosing.
• Safety and Precautions: Use with caution in patients with cardiovascular disorders and avoid use with MAO inhibitors.

FAQs

Q: What is Clarinex-D 24 Hour used for? A: Clarinex-D 24 Hour is used for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion.

Q: When was Clarinex-D 24 Hour approved by the FDA? A: Clarinex-D 24 Hour was approved by the FDA on March 3, 2005.

Q: What are the common adverse reactions associated with Clarinex-D 24 Hour? A: Common adverse reactions include dry mouth, headache, insomnia, fatigue, and somnolence.

Q: Can Clarinex-D 24 Hour be used with other antihistamines or decongestants? A: It is advised to use caution when taking Clarinex-D 24 Hour with other antihistamines or decongestants due to potential cardiovascular effects.

Q: Is there a generic version of Clarinex-D 24 Hour available? A: No, there is currently no therapeutically equivalent generic version of Clarinex-D 24 Hour available in the United States.

Cited Sources

1. RxList - Clarinex-D 24hr (Desloratadine and Pseudoephedrine Sulfate)
2. Schering-Plough Corporation - 2000 Annual Report
3. Drugs.com - Generic Clarinex-D 12 Hour Availability
4. Drugs.com - Clarinex-D 24 Hour FDA Approval History
5. Biospace - Schering-Plough Corporation Says FDA Approves 12-Hour Clarinex