CLARINEX-D 12 HOUR Drug Patent Profile

When do Clarinex-d 12 Hour patents expire, and when can generic versions of Clarinex-d 12 Hour launch?

Clarinex-d 12 Hour is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in CLARINEX-D 12 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 12 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	19
Patent Applications:	6
What excipients (inactive ingredients) are in CLARINEX-D 12 HOUR?	CLARINEX-D 12 HOUR excipients list
DailyMed Link:	CLARINEX-D 12 HOUR at DailyMed

Recent Clinical Trials for CLARINEX-D 12 HOUR

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

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

See all CLARINEX-D 12 HOUR clinical trials

Pharmacology for CLARINEX-D 12 HOUR

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for CLARINEX-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes

Expired US Patents for CLARINEX-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,214,684*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	4,659,716*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	8,187,630
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,618,649*PED

International Patents for CLARINEX-D 12 HOUR

See the table below for patents covering CLARINEX-D 12 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1674084
Japan	H10512240
Germany	3677842
Taiwan	I222885

Supplementary Protection Certificates for CLARINEX-D 12 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	SPC063/2007	Ireland		SPC063/2007: 20081105, EXPIRES: 20220729
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	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730

CLARINEX-D 12 HOUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLARINEX-D 12 HOUR

Introduction to CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR is an extended-release tablet formulation that combines the antihistamine desloratadine with the decongestant pseudoephedrine sulfate. It is designed to provide relief from the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, sneezing, runny nose, itchy throat, and itchy and watery eyes[1][3][4].

FDA Approval and Market Entry

The U.S. Food and Drug Administration (FDA) approved CLARINEX-D 12 HOUR in February 2006, with the product becoming available nationwide in March 2006, just in time for the spring allergy season. This approval was based on the results of two clinical trials involving 1,248 patients with seasonal allergic rhinitis, which demonstrated the efficacy and safety of the drug[1][4].

Market Need and Target Audience

CLARINEX-D 12 HOUR addresses a significant need in the allergy treatment market, particularly for patients who experience nasal congestion as their most bothersome symptom. A survey of 1,000 adults with allergic rhinitis found that nearly 85% experience nasal congestion upon waking, making it a prevalent morning symptom[1].

Clinical Efficacy

The clinical trials for CLARINEX-D 12 HOUR showed that the drug was significantly more effective than pseudoephedrine alone in reducing non-nasal symptoms and more effective than desloratadine alone in reducing nasal congestion. This dual-action approach provides comprehensive relief for patients with seasonal allergic rhinitis[1][4].

Dosage and Administration

The recommended dose of CLARINEX-D 12 HOUR is one tablet twice a day, administered approximately 12 hours apart, with or without a meal. Higher doses or increased dosing frequency have not demonstrated increased effectiveness and are not recommended due to potential adverse effects[3].

Safety Profile

The safety data from clinical trials indicate that CLARINEX-D 12 HOUR is generally well-tolerated. Common adverse reactions include insomnia, headache, dry mouth, fatigue, somnolence, and pharyngitis. However, the drug should be used with caution in patients with cardiovascular disorders and is contraindicated in those with severe hypertension or severe coronary artery disease[1][3].

Market Impact and Competition

CLARINEX-D 12 HOUR entered a market dominated by other allergy treatments, including Schering-Plough's own CLARITIN line, which was the largest-selling nonsedating antihistamine at the time. The introduction of CLARINEX-D 12 HOUR provided physicians with another option for tailoring allergy treatment regimens based on patients' specific symptoms and needs[1][2].

Financial Performance

The financial performance of CLARINEX-D 12 HOUR is closely tied to the overall performance of Schering-Plough's allergy and respiratory franchise. In 2006, Schering-Plough reported strong financial results, with worldwide pharmaceutical sales growing 8% to $9.8 billion. However, the specific financial impact of CLARINEX-D 12 HOUR was not isolated in these reports. It is worth noting that the decline in sales of CLARITIN-D and other over-the-counter (OTC) products in the first quarter of 2006 did not directly reflect the performance of CLARINEX-D 12 HOUR, as it was a prescription-only product[2][5].

Market Positioning

CLARINEX-D 12 HOUR was positioned as a convenient and effective treatment option that combines the benefits of an antihistamine and a decongestant in a single, extended-release formulation. This positioning helped it to carve out a niche in the market, particularly among patients who preferred a twice-daily dosing regimen without the drowsiness associated with some other antihistamines[1].

Physician and Patient Acceptance

Physicians welcomed CLARINEX-D 12 HOUR as it provided a new option for managing seasonal allergic rhinitis. Dr. William Lumry, an allergist, noted that the combination of an antihistamine and decongestant in a single formulation offered safe and effective relief for patients with nasal congestion and other allergy symptoms[1].

Long-Term Financial Trajectory

While specific long-term financial data for CLARINEX-D 12 HOUR is not readily available, the drug's approval and market entry were part of Schering-Plough's broader strategy to expand its global allergy and respiratory franchise. The company's consistent growth in this sector, driven by products like CLARITIN and CLARINEX, suggests that CLARINEX-D 12 HOUR contributed positively to the company's financial performance over time[2].

Conclusion

CLARINEX-D 12 HOUR has been a significant addition to the allergy treatment market, offering a unique combination of antihistaminic and decongestant properties in an extended-release formulation. Its approval and market entry were well-timed to address the needs of patients during the peak allergy season. While specific financial data for the drug is not isolated, it is clear that it has played a role in Schering-Plough's overall success in the allergy and respiratory sector.

Key Takeaways

• FDA Approval: CLARINEX-D 12 HOUR was approved by the FDA in February 2006.
• Market Need: Addresses the significant need for effective relief from nasal congestion and other symptoms of seasonal allergic rhinitis.
• Clinical Efficacy: Demonstrated superior efficacy compared to pseudoephedrine alone and desloratadine alone in clinical trials.
• Safety Profile: Generally well-tolerated but with caution advised for patients with cardiovascular disorders.
• Market Positioning: Positioned as a convenient and effective treatment option with a twice-daily dosing regimen.
• Physician and Patient Acceptance: Welcomed by physicians and patients for its safe and effective relief.

FAQs

Q: What is CLARINEX-D 12 HOUR used for? A: CLARINEX-D 12 HOUR is used for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, sneezing, runny nose, itchy throat, and itchy and watery eyes.

Q: How is CLARINEX-D 12 HOUR administered? A: The recommended dose is one tablet twice a day, administered approximately 12 hours apart, with or without a meal.

Q: What are the common adverse reactions associated with CLARINEX-D 12 HOUR? A: Common adverse reactions include insomnia, headache, dry mouth, fatigue, somnolence, and pharyngitis.

Q: Is CLARINEX-D 12 HOUR suitable for all patients? A: No, it is contraindicated in patients with severe hypertension or severe coronary artery disease and should be used with caution in patients with cardiovascular disorders.

Q: How does CLARINEX-D 12 HOUR compare to other allergy treatments? A: CLARINEX-D 12 HOUR offers a unique combination of antihistaminic and decongestant properties in an extended-release formulation, providing comprehensive relief for patients with seasonal allergic rhinitis.

Sources

1. Schering-Plough Corporation Says FDA Approves 12-Hour Clarinex - Biospace
2. Schering-Plough Corporation - Annual Report 2000
3. CLARINEX-D 12 HOUR- desloratadine and pseudoephedrine - DailyMed
4. CLARINEX-D® 12 HOUR PRODUCT - FDA Label
5. Schering-Plough Corporation Reports Financial Results For First Quarter of 2006 - Biospace