QUZYTTIR Drug Patent Profile

When do Quzyttir patents expire, and what generic alternatives are available?

Quzyttir is a drug marketed by JDP and is included in one NDA. There are five patents protecting this drug.

This drug has five patent family members in five countries.

The generic ingredient in QUZYTTIR is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quzyttir

A generic version of QUZYTTIR was approved as cetirizine hydrochloride by PADAGIS US on June 17^th, 2008.

Summary for QUZYTTIR

International Patents:	5
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	2
Patent Applications:	2,727
Drug Prices:	Drug price information for QUZYTTIR
What excipients (inactive ingredients) are in QUZYTTIR?	QUZYTTIR excipients list
DailyMed Link:	QUZYTTIR at DailyMed

See drug prices for QUZYTTIR

Recent Clinical Trials for QUZYTTIR

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

Sponsor	Phase
JDP Therapeutics, Inc.	Phase 2
TerSera Therapeutics	Phase 2
TerSera Therapeutics LLC	Phase 2

See all QUZYTTIR clinical trials

Pharmacology for QUZYTTIR

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

US Patents and Regulatory Information for QUZYTTIR

QUZYTTIR is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes	9,180,090
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes	8,263,581
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes	8,314,083
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes	8,513,259
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes	9,119,771

International Patents for QUZYTTIR

See the table below for patents covering QUZYTTIR around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2616703
World Intellectual Property Organization (WIPO)	2011003074
Australia	2010266103	Non-sedating antihistamine injection formulations and methods of use thereof
Canada	2803987	FORMULATIONS POUR INJECTION D'UN ANTIHISTAMINIQUE NON SEDATIF ET LEURS METHODES D'UTILISATION (NON-SEDATING ANTIHISTAMINE INJECTION FORMULATIONS AND METHODS OF USE THEREOF)
European Patent Office	2477634	FORMULATIONS POUR INJECTION D'UN ANTIHISTAMINIQUE NON SÉDATIF ET LEURS MÉTHODES D'UTILISATION (NON-SEDATING ANTIHISTAMINE INJECTION FORMULATIONS AND METHODS OF USE THEREOF)

Supplementary Protection Certificates for QUZYTTIR

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

Market Dynamics and Financial Trajectory for QUZYTTIR (Cetirizine Hydrochloride Injection)

Introduction to QUZYTTIR

QUZYTTIR, a brand name for cetirizine hydrochloride injection, is a medication used primarily for the treatment of acute urticaria and other allergic reactions. Understanding its market dynamics and financial trajectory involves analyzing various factors, including clinical efficacy, market demand, competition, and budget impact.

Clinical Efficacy of QUZYTTIR

Phase 3 Trial Outcomes

In the phase 3 clinical trial, QUZYTTIR demonstrated significant efficacy in reducing pruritus, a primary endpoint. The patient-rated pruritus score change from baseline at 2 hours showed a favorable outcome for QUZYTTIR compared to diphenhydramine (DPH)[1].

• Patient-Rated Pruritus Scores: The trial indicated that QUZYTTIR was effective in reducing pruritus, with a severity score graded on a scale of 0 to 3.
• Return Visits: The proportion of patients returning to any emergency department or clinic was lower in the QUZYTTIR treatment group (6%) compared to the DPH group.

Market Demand and Growth

Global Market Outlook

The global cetirizine hydrochloride market is projected to exhibit growth during the forecast period from 2020 to 2029. This growth is driven by increasing demand for antihistamines in treating allergic reactions.

• Regional Segmentation: The market is segmented into regions such as North America, South America, Asia and Pacific, Europe, and the Middle East and Africa. Each region has its own set of key countries and market dynamics[3].
• Competitive Landscape: The market is substantially consolidated with key players like Teva, UCB Pharma, Lunan Pharma, Amneal, and others. However, new entrants are expected to intensify competition in the coming years[3].

Financial Trajectory

Budget Impact Analysis

The adoption of QUZYTTIR in emergency department settings has shown a positive budget impact.

• Cost Savings: A study found that the use of IV cetirizine instead of IV diphenhydramine resulted in a net positive budget impact of $27,876 annually. This is due to reduced return visits and faster discharge times, allowing for more patients to be treated[4].
• Revenue Generation: The early discharge of patients treated with IV cetirizine can lead to additional revenue as more patients can be seen in the emergency department. This is estimated to generate an incremental annual net revenue of $1,428 from additional patients seen[4].

Drug Costs and Reimbursement

• Wholesale Acquisition Cost (WAC): The drug cost for IV cetirizine is modeled using the lowest reported WAC, with a markup set at 3% as per Medicare reimbursement standards[4].
• Comparison with IV Diphenhydramine: IV cetirizine has a lower sedation score and fewer adverse effects compared to IV diphenhydramine, which can also impact the overall cost and patient satisfaction[4].

Market Drivers and Challenges

Market Drivers

• Increasing Allergic Reactions: The rising incidence of allergic reactions and acute urticaria drives the demand for effective antihistamines like QUZYTTIR.
• Clinical Efficacy: The proven efficacy of QUZYTTIR in reducing pruritus and minimizing return visits to emergency departments is a significant market driver[1][4].

Market Challenges

• Competition: The presence of established players and potential new entrants in the market poses a competitive challenge.
• Regulatory Environment: The market is influenced by regulatory frameworks such as the Prescription Drug User Fee Act (PDUFA), which can affect the approval and review process of new drugs[2].

Key Players and Market Share

The cetirizine hydrochloride market is dominated by several key players, including:

• Teva
• UCB Pharma
• Lunan Pharma
• Amneal
• Jubilant Life Sciences
• Pfizer
• J & J
• Hunan Jiudian Pharm
• Sun Pharma
• HAILISHENG
• Mylan
• HUAPONT Pharm[3]

These companies play a crucial role in shaping the market through their production, sales, and competitive strategies.

Future Trends and Developments

Market Predictions

• Growth Projections: The global cetirizine hydrochloride market is expected to grow at a significant CAGR during the forecast period, driven by increasing demand and new market entrants[3].
• Geographical Expansion: The market is expected to see growth in various regions, with key countries such as the United States, China, Japan, and India playing significant roles[3].

Industrial Developments

• New Formulations: The development of new formulations and delivery methods for cetirizine hydrochloride could further enhance its market position.
• Regulatory Approvals: Ongoing regulatory approvals and compliance with PDUFA goals will continue to influence the market dynamics[2].

Key Takeaways

• Clinical Efficacy: QUZYTTIR has demonstrated significant efficacy in reducing pruritus and minimizing return visits to emergency departments.
• Positive Budget Impact: The adoption of QUZYTTIR has a positive net budget impact due to reduced return visits and faster discharge times.
• Market Growth: The global cetirizine hydrochloride market is projected to grow significantly, driven by increasing demand and new market entrants.
• Competitive Landscape: The market is competitive with several key players, and new entrants are expected to intensify competition.

FAQs

What is QUZYTTIR used for?

QUZYTTIR is used for the treatment of acute urticaria and other allergic reactions.

How does QUZYTTIR compare to IV diphenhydramine in terms of efficacy?

QUZYTTIR has shown better efficacy in reducing pruritus and sedation scores compared to IV diphenhydramine in clinical trials[1][4].

What is the budget impact of adopting QUZYTTIR in emergency departments?

The adoption of QUZYTTIR has a positive net budget impact of $27,876 annually due to reduced return visits and faster discharge times[4].

Who are the key players in the cetirizine hydrochloride market?

Key players include Teva, UCB Pharma, Lunan Pharma, Amneal, Jubilant Life Sciences, Pfizer, J & J, and others[3].

What are the growth projections for the global cetirizine hydrochloride market?

The market is expected to grow at a significant CAGR during the forecast period from 2020 to 2029, driven by increasing demand and new market entrants[3].

Sources

1. Efficacy | Quzyttir® (cetirizine hydrochloride injection) - Quzyttir
2. FY 2020 PDUFA Performance Report - FDA
3. Cetirizine Hydrochloride Market Key Players, Sales, Demand ... - Biospace
4. Budget Impact of Intravenous Cetirizine Hydrochloride for the ... - AHDB Online

Last updated: 2024-12-19