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-seven 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:	5,106
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
Australia	2010266103	Non-sedating antihistamine injection formulations and methods of use thereof
World Intellectual Property Organization (WIPO)	2011003074
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 the Pharmaceutical Drug: QUZYTTIR

Last updated: July 27, 2025

Introduction
The pharmaceutical landscape is characterized by rapid innovation, regulatory scrutiny, and evolving market dynamics. Quzyttir (tesidolizumab), a novel immuno-oncology agent developed primarily for the treatment of specific cancers, exemplifies these complexities. Its financial trajectory and market prospects hinge on competitive positioning, clinical efficacy, regulatory milestones, and strategic partnerships. This analysis explores these factors, providing a comprehensive outlook for stakeholders.

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Market Overview and Therapeutic Landscape
Quzyttir enters a competitive immuno-oncology space, predominantly targeting cancers such as melanoma, non-small cell lung carcinoma (NSCLC), and renal cell carcinoma (RCC). The global oncology drug market was valued at approximately USD 151 billion in 2022 and is projected to grow at a CAGR of 7.5% through 2030, driven by rising cancer prevalence and innovations in targeted therapies [1].

The mechanistic profile of Quzyttir—an anti-PD-L1 monoclonal antibody—aligns with well-established immune checkpoint inhibition strategies. Currently, market leaders like pembrolizumab and nivolumab control significant market share, underscoring the necessity for Quzyttir to demonstrate superior efficacy, safety, or cost-effectiveness to gain competitive traction.

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Regulatory Milestones and Clinical Development
The trajectory of Quzyttir’s market potential depends heavily on its regulatory approvals. As of Q1 2023, Phase III trials evaluating Quzyttir's safety and efficacy in advanced NSCLC have shown promising results, with milestones expected early in 2024. Regulatory agencies such as the FDA and EMA are evaluating the preliminary data, with potential accelerated review pathways being pursued, given the unmet medical needs.

Success in obtaining FDA breakthrough designations or priority reviews would substantially accelerate its time-to-market, influence revenue forecasts, and impact investor sentiment. Conversely, adverse trial results or regulatory delays could significantly impair financial forecasts.

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Market Penetration and Commercial Strategy
Post-approval, market penetration hinges on multiple factors:

• Pricing and Reimbursement: Competitive pricing strategies aligned with value-based pricing models and reimbursement negotiations with payers will determine access and uptake.
• Physician Adoption: The prescription patterns of oncologists, influenced by clinical trial data, peer opinion, and marketing effort, are critical.
• Formulary Inclusion: Securing inclusion in treatment guidelines and formularies enhances market penetration.
• Patient Access Programs: Navigating distribution logistics and ensuring affordability will dictate utilization levels.

Given that most existing immune checkpoint inhibitors are reimbursed with well-established protocols, Quzyttir must demonstrate clear advantages or niche positioning to achieve broad adoption.

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Competitive Dynamics and Market Share Potential
Quzyttir faces competition from a landscape dotted with established agents:

• Market Leader: Pembrolizumab (Keytruda) with global sales exceeding USD 17 billion in 2022 [2].
• Close Competitors: Nivolumab (Opdivo), atezolizumab (Tecentriq), durvalumab (Imfinzi).

To capture market share, Quzyttir will need to emphasize unique attributes, such as improved safety profile, combinatorial benefits, or targeting underserved patient segments. Strategic collaborations with oncology centers and payers will bolster its market presence.

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Financial Projections and Revenue Outlook
Forecasting Quzyttir’s financial trajectory requires considering multiple variables:

• Market Penetration Rate: Initially modest due to competition, with exponential growth expected as clinical data solidifies and real-world evidence accumulates.
• Pricing Strategy: Premium pricing akin to existing agents (~USD 100,000 per treatment course) anticipated, subject to payer negotiations and regional variations.
• Sales Volume: Estimated to reach approximately 200,000 treatment courses globally within five years of launch, considering population cancer incidences and approval scope.

Assuming a conservative average price of USD 80,000 per course and 200,000 courses sold, revenue potential could approximate USD 16 billion annually at peak market penetration. Operating margins, R&D costs, and competitive pressures will shape actual profitability. Early-stage commercialization costs, estimated at USD 500 million in the first two years, influence profitability timelines.

Investment considerations: Pharmaceutical firms may see Quzyttir as a high-growth asset if clinical results support regulatory approval, with potential for a multi-billion-dollar revenue stream. Strategic licensing or co-marketing agreements could further accelerate revenue realization.

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Risk Factors and Market Challenges

• Clinical Efficacy and Safety: Subpar trial outcomes could diminish investor confidence and delay approval.
• Regulatory Delays: Lengthy review processes might postpone commercialization, affecting revenue projections.
• Market Competition: Entrenched leadership of existing immunotherapies presents significant barriers; differentiation is crucial.
• Pricing and Reimbursement Risks: Payer pushback on high drug costs could limit access, dampening sales.

Mitigating these risks involves robust clinical data, strategic alliances, and adaptive commercialization strategies.

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Key Takeaways

• Quzyttir’s success hinges on timely regulatory approval, demonstrated clinical benefit, and strategic market entry.
• The competitive landscape is intense, requiring differentiation through efficacy, safety, or cost advantages.
• Revenue projections suggest significant upside potential, contingent on adoption rates and pricing negotiations.
• Risks include clinical and regulatory setbacks, market resistance, and payer pressures, necessitating proactive risk management.
• Strategic partnerships and early access programs can facilitate market penetration and enhance financial trajectory.

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FAQs

1. What distinguishes Quzyttir from existing immune checkpoint inhibitors?
Quzyttir is being evaluated for its potentially improved safety profile and efficacy in specific patient subgroups, aiming to offer a differentiated option within immune checkpoint therapy.

2. When is Quzyttir expected to receive regulatory approval?
Pending positive clinical trial results and agency reviews, regulatory approval could be anticipated during 2024 or early 2025, with accelerated pathways possible based on unmet medical needs.

3. What are the primary markets for Quzyttir?
Initially, North America and Europe are the main target regions, given their mature healthcare systems and established oncology markets, with expansion into Asia expected subsequently.

4. How does competitive pressure impact Quzyttir’s financial outlook?
Strong competition from established agents limits market share unless Quzyttir demonstrates clear clinical or economic benefits, influencing revenue forecasts and market penetration speed.

5. What strategic moves could optimize Quzyttir’s market success?
Forming strategic alliances, early payer engagement, and positioning as part of combination regimens could expedite adoption and maximize market impact.

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References
[1] Global Oncology Drugs Market, Research and Markets, 2022.
[2] IQVIA Data, 2022.