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
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007

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
Romania	122476	TABLETĂ CONŢINÂND CETIRIZINĂ ŞI PSEUDOEFEDRINĂ (TABLET CONTAINING CETIRIZINE AND PSEUDOEPHEDRINE)
Denmark	44082
European Patent Office	1404304	COMPRIME CONTENANT DE LA CETIRIZINE ET DE LA PSEUDOEPHEDRINE (TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE)
Guatemala	199700037	COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE LA RINITIS
Estonia	05357	Tablett, mis sisaldab v hemalt kahte eristatavat segmenti, ning selle kasutamine
Peru	42598	COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE LA RINITIS

Supplementary Protection Certificates for ZYRTEC-D 12 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	SPC/GB01/052	United Kingdom		SPC/GB01/052:, EXPIRES: 20070205

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