ZYRTEC-D 12 HOUR Drug Patent Profile

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

Zyrtec-d 12 Hour is a drug marketed by J And J Consumer Inc and is included in one NDA.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyrtec-d 12 Hour

A generic version of ZYRTEC-D 12 HOUR was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

Summary for ZYRTEC-D 12 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	30
Patent Applications:	1
DailyMed Link:	ZYRTEC-D 12 HOUR at DailyMed

Recent Clinical Trials for ZYRTEC-D 12 HOUR

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

Sponsor	Phase
Emory University	Phase 4
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 1
Indiana University	Phase 4

See all ZYRTEC-D 12 HOUR clinical trials

Pharmacology for ZYRTEC-D 12 HOUR

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

Paragraph IV (Patent) Challenges for ZYRTEC-D 12 HOUR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC-D 12 HOUR	Extended-release Tablets	cetirizine hydrochloride; pseudoephedrine hydrochloride	5 mg/120 mg	021150	1	2004-06-02

US Patents and Regulatory Information for ZYRTEC-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
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007		OTC	Yes	Yes

Expired US Patents for ZYRTEC-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007	6,469,009
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007	7,226,614
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007	6,489,329
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007	7,014,867

International Patents for ZYRTEC-D 12 HOUR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1199918	ACIDES 2-[4-(DIPHENYLMETHYL)-1-PIPERAZINYL] ACETIQUES ET LEURS AMIDES (2-[4-(DIPHENYLMETHYL)-1-PIPERAZINYL]-ACETIC ACIDS AND THEIR AMIDES)
Costa Rica	7198	TABLETA QUE CONTIENE CETIRIZINA Y PSEUDOEFEDRINA
Luxembourg	90870
Yugoslavia	43511

Supplementary Protection Certificates for ZYRTEC-D 12 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0058146	SPC/GB01/052	United Kingdom		SPC/GB01/052:, EXPIRES: 20070205
0663828	C300085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
0058146	2001C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103

ZYRTEC-D 12 HOUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zyrtec-D 12 Hour

Introduction

Zyrtec-D 12 Hour is a widely used over-the-counter (OTC) medication that combines the antihistamine cetirizine hydrochloride with the nasal decongestant pseudoephedrine hydrochloride. This dual-action formula provides relief from a range of allergy symptoms, including nasal congestion, sneezing, itchy eyes, and sinus pressure.

Market Demand and Growth

The demand for Zyrtec-D 12 Hour is driven by the prevalence of allergic rhinitis and other respiratory allergies. With a significant portion of the population suffering from seasonal and perennial allergies, the market for allergy medications remains robust.

• Seasonal and Perennial Allergies: The high incidence of hay fever and other respiratory allergies ensures a consistent demand for effective allergy relief medications like Zyrtec-D 12 Hour[4].
• Consumer Preference: The convenience of a dual-action formula that combines an antihistamine and a decongestant in one tablet enhances its appeal to consumers, contributing to its market growth[5].

Competitive Landscape

The allergy medication market is highly competitive, with several brands offering similar products. However, Zyrtec-D 12 Hour maintains a strong market position due to its proven efficacy and brand recognition.

• Brand Recognition: Zyrtec is a well-established brand, and the addition of a decongestant in Zyrtec-D 12 Hour enhances its value proposition, making it a preferred choice for many consumers[4].
• Competitors: Other notable competitors in the market include Claritin-D, Allegra-D, and Sudafed, but Zyrtec-D 12 Hour's unique formulation and marketing efforts help it stand out[2].

Pricing and Cost

The pricing of Zyrtec-D 12 Hour can vary depending on the retailer and any available discounts.

• Retail Pricing: The average retail cost of Zyrtec-D 12 Hour is around $30 to $50 for a pack of 24 tablets, although prices can be lower with discount cards or promotions[2].
• Discounts and Savings: Programs like SingleCare offer significant discounts, bringing the cost down to as low as $10 for 12-hour tablets, making the medication more accessible to a wider audience[2].

Insurance Coverage

Unlike some prescription medications, Zyrtec-D 12 Hour is generally not covered by insurance or Medicare Part D due to its OTC status.

• OTC Status: Being available over the counter means that consumers typically pay out-of-pocket for Zyrtec-D 12 Hour, although it may be eligible for Flexible Spending Accounts (FSAs)[2][5].

Financial Performance

The financial performance of Zyrtec-D 12 Hour is influenced by its sales volume, pricing, and market share.

• Sales Volume: With its widespread use and strong brand presence, Zyrtec-D 12 Hour generates significant revenue. The medication's ability to provide 12 hours of relief from allergy symptoms contributes to its high sales volume[5].
• Market Share: As a leading brand in the allergy medication market, Zyrtec-D 12 Hour captures a substantial market share, which is a key factor in its financial success[4].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the financial trajectory of Zyrtec-D 12 Hour.

• Convenience and Efficacy: Consumers prefer medications that offer quick and effective relief. Zyrtec-D 12 Hour's dual-action formula and extended-release mechanism make it a preferred choice, driving sales and revenue[4][5].
• Lifestyle Impact: The medication's ability to provide relief without significant drowsiness or other side effects that could impact daily activities is a major selling point, especially for busy professionals and students[4].

Regulatory and Safety Considerations

Regulatory and safety considerations can impact the market dynamics and financial performance of Zyrtec-D 12 Hour.

• Contraindications and Precautions: The medication is contraindicated in patients with certain conditions, such as narrow-angle glaucoma, urinary retention, and hypertension. These contraindications can affect its market reach but also underscore the importance of proper usage and medical supervision[1][3].
• Side Effects: Common side effects include drowsiness, headache, dizziness, and fatigue, as well as pseudoephedrine-specific side effects like insomnia and heart palpitations. Managing these side effects is crucial for maintaining consumer trust and market position[2][3].

Clinical Trials and Efficacy

The efficacy of Zyrtec-D 12 Hour has been established through clinical trials.

• Clinical Trials: Multicenter, randomized, double-blind trials have shown that Zyrtec-D 12 Hour significantly reduces the Total Symptom Severity Complex (TSSC) score, which includes symptoms like sneezing, runny nose, itchy eyes, and nasal congestion[1][3].

Distribution and Availability

The availability of Zyrtec-D 12 Hour is widespread, making it easily accessible to consumers.

• Retail Availability: The medication is available behind the pharmacy counter at various retail outlets, including pharmacies and online stores like Costco[5].

Key Takeaways

• Strong Market Demand: Driven by the prevalence of allergic rhinitis and consumer preference for dual-action formulas.
• Competitive Advantage: Zyrtec-D 12 Hour's brand recognition and proven efficacy set it apart in a competitive market.
• Pricing and Discounts: Available at various price points with potential discounts through programs like SingleCare.
• Financial Performance: Significant revenue generated due to high sales volume and market share.
• Consumer Preferences: Convenience, efficacy, and minimal lifestyle impact are key drivers of consumer choice.
• Regulatory Considerations: Important to adhere to contraindications and precautions to ensure safe usage.

Frequently Asked Questions

1. What is Zyrtec-D 12 Hour used for?

Zyrtec-D 12 Hour is used for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis, including sneezing, runny nose, itchy eyes, and sinus pressure[1][4].

2. How often should I take Zyrtec-D 12 Hour?

Adults and children 12 years and older should take one tablet every 12 hours. Children 6 to 11 years old should take half a tablet every 12 hours[4].

3. Can I take Zyrtec-D 12 Hour with food?

Yes, Zyrtec-D 12 Hour can be taken with or without food, as food does not significantly affect the absorption of either cetirizine or pseudoephedrine[1].

4. What are the common side effects of Zyrtec-D 12 Hour?

Common side effects include drowsiness, headache, dizziness, fatigue, dry mouth, and pseudoephedrine-specific side effects like insomnia and heart palpitations[2][3].

5. Is Zyrtec-D 12 Hour covered by insurance?

No, Zyrtec-D 12 Hour is generally not covered by insurance or Medicare Part D due to its over-the-counter status[2].

Sources:

1. ZYRTEC-D 12 HOUR™ - accessdata.fda.gov
2. Zyrtec vs. Zyrtec-D: Differences, similarities, and which is better for you - SingleCare
3. ZYRTEC-D 12 HOUR - accessdata.fda.gov
4. The Ultimate Guide to Zyrtec D: Benefits, Side Effects, and Usage - Cabinet Health
5. Zyrtec-D 12 Hour Allergy & Sinus Medicine & Nasal Decongestant - Costco