QBRELIS Drug Patent Profile

When do Qbrelis patents expire, and when can generic versions of Qbrelis launch?

Qbrelis is a drug marketed by Azurity and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lisinopril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qbrelis

A generic version of QBRELIS was approved as lisinopril by ANNORA PHARMA on July 1^st, 2002.

Summary for QBRELIS

International Patents:	10
US Patents:	12
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QBRELIS

Paragraph IV (Patent) Challenges for QBRELIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QBRELIS	Oral Solution	lisinopril	1 mg/mL	208401	1	2019-10-24

US Patents and Regulatory Information for QBRELIS

QBRELIS is protected by thirty-two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	12,128,083		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	9,814,751		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	10,940,177		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	9,616,096

International Patents for QBRELIS

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

Country	Patent Number	Title	Estimated Expiration
Spain	2886869
South Korea	20180069907	리시노프릴 제제
Japan	2018533583	リシノプリル製剤
China	108472252	赖诺普利制剂 (LISINOPRIL FORMULATIONS)

QBRELIS: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

QBRELIS (palonosetron hydrochloride) is a pharmaceutical compound indicated primarily for preventing chemotherapy-induced nausea and vomiting (CINV). As a niche drug within the antiemetic class, it faces a complex market landscape influenced by regulatory pathways, competitive pressures, and evolving treatment protocols. This report provides an industry-focused analysis of QBRELIS’s investment scenario, delineates key market dynamics, and projects its financial trajectory over the next five years. Emphasis is placed on sales potential, patent landscape, competitive positioning, and regulatory considerations, supporting investors and stakeholders in strategic decision-making.

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What is the Current Market Position of QBRELIS?

Aspect	Details
Generic Name	Palonosetron hydrochloride
Indication	Chemotherapy-induced nausea and vomiting (CINV) prevention
Approval Year (US)	2003 (as Aloxi, by Helsinn)
Ownership	Originally developed by Helsinn; licensed to various companies for regional markets
Formulations	Intravenous (IV), prefilled syringes
Current Market Status	Generic competition dominates; branded sales limited to certain regions

QBRELIS is the generic formulation of the pioneer drug Aloxi. As of 2023, it primarily addresses hospital and infusion center markets, with sales driven by on-label use in oncology settings. The drug's market share and sales volume are affected by patent cliffs and the availability of alternative agents.

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Market Dynamics for QBRELIS

1. Competitive Landscape

Competitor	Drug Name	Type	Market Share (Estimated, 2023)	Notable Features
MDSL	Ondansetron (Zofran)	5-HT3 antagonist	Moderate	Widely used, low cost, oral/parenteral
Heron	Granisetron (Kytril)	5-HT3 antagonist	Moderate	Comparable efficacy, IV options
GSK	Rolapitant (Varubi)	NK1 receptor antagonist	Niche	Often combined with 5-HT3 antagonists
Helsinn	Palonosetron (Aloxi), QBRELIS	5-HT3 antagonist	Limited (generic segment)	Long half-life, efficacy in delayed CINV

The generic market rapidly eroded the original branded sales post-patent expiry (2018 in major jurisdictions), reducing QBRELIS’s revenue base to price-sensitive institutional buyers.

2. Regulatory and Patent Considerations

Item	Details
Patent Status	Patents expired or nearing expiry (expired globally in 2018)
Regulatory Pathways	Generic approval via Abbreviated New Drug Application (ANDA)
Market Entry Barriers	No patents to block generics; market entry driven primarily by price and formulary acceptance

Patent expiration significantly limits exclusivity. However, some regional restrictions may offer limited market retention strategies, such as existing procurement contracts or formulations with unique excipients.

3. Pricing Dynamics

Region	Branded Price (USD)	Generic Price (USD)	Price Trend (2020–2023)	Factors Influencing Prices
US	$150–180 per dose	$20–$50 per dose	Declined 50%–70%	Increased generic competition; hospital tender processes
EU	€130–€170	€15–€40	Similar trend	Regulatory pressures and cost-containment measures
Asia	$100–$150	$10–$30	Volatile, affected by local policies	Local generic manufacturing

4. Payment and Reimbursement Dynamics

• In the US, Medicare and private insurers favor lower-cost generics, constraining margins for remaining branded or high-cost products.
• In Europe, reimbursement policies favor generics, further compressing pricing.

5. Market Adoption and Clinical Guidelines

• Use of palonosetron as first-line for moderate-to-high emetogenic chemotherapy remains stable due to its efficacy profile.
• Newer drugs and combination therapies (NK1 antagonists) are gradually shifting treatment paradigms, potentially impacting QBRELIS’s market share.

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Financial Trajectory Forecast (2023–2028)

1. Revenue Outlook

Year	Estimated Global Sales (USD millions)	Growth Rate	Drivers	Risks
2023	$50	—	Existing hospital demand, delayed generic penetration	Price erosion, generics flooding
2024	$40	-20%	Increased competition	Market entry of new antiemetics
2025	$30	-25%	Patent expiry, price competition	Shift to oral or alternative agents
2026	$20	-33%	Market saturation	Cost-driven substitution
2027	$15	-25%	Market stabilization	M&A activity affecting demand
2028	$10	-33%	Further generic price declines

Note: These projections assume no new formulations or indications, with sales primarily from existing hospital formularies.

2. Cost Structure and Margin Analysis

Aspect	Details
Manufacturing Cost per Dose	Approx. $2–$4 (generic manufacturing)
Gross Margin (Post-Patent Expiry)	10%–20% at current competitive prices
Operational Costs	Marketing, regulatory compliance, distribution

3. Investment Opportunities and Risks

Opportunities	Risks
Entry into emerging markets with lower generic penetration	Price compression due to increasing generic supply
Co-marketing with local distributors	Limited differentiation post-patent expiry
Developing combination products or novel formulations	Competitor innovation from NK1 agents and oral therapies

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Comparison with Competing Anti-emetics

Agent	Type	Route	Efficacy	Duration	Patent Status	Market Share (2023)
Palonosetron (QBRELIS)	5-HT3	IV	High	Long (up to 96 hours)	Expired	Small (generic segment)
Ondansetron	5-HT3	Oral/IV	Moderate	Short	Patent expired	Major (generic)
Granisetron	5-HT3	Oral/IV	Moderate	Short	Patent expired	Moderate
Aprepitant	NK1	Oral	High	72 hours	Patent expired	Growing at high cost

QBRELIS’s differentiator remains its long half-life and efficacy in delayed CINV, but its market share declines as clinicians adopt more cost-effective agents.

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Key Market Trends and Future Drivers

Trend	Impact	Actions
Digital health integration	Potential for remote monitoring, adherence tracking	Invest in digital solutions to differentiate offerings
New formulation development	Extended patent life, improved patient convenience	R&D into oral, transdermal, or implantable forms
Regulatory updates	Faster approvals for biosimilars, generics	Accelerate generic registration strategies
Healthcare cost containment	Push towards lower-cost generics	Focus on price competitiveness

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Key Takeaways

• Market Exhaustion of Patent Exclusivity: All major patents for palonosetron, including QBRELIS, have expired, leading to near-total generic market penetration.
• Pricing and Margin Compression: Significant reduction in per-dose prices; margins are increasingly slim post-generic entry.
• Growth Limited by Competition: Volume growth is constrained; possible decline without innovation or niche market focus.
• Regional Variability: Growth potential remains in emerging markets with lower generic penetration; mature markets face declining revenues.
• Strategic Opportunities: Entry into combination therapies, biosimilars, or alternative delivery systems may offer future growth pathways.

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FAQs

1. What are the primary competitors to QBRELIS in the antiemetic market?
Major competitors include ondansetron (Zofran), granisetron, and NK1 antagonists such as aprepitant. These agents vary in efficacy, route, and cost, often leading to substitution based on price sensitivity and clinical guidelines.

2. How does the expiration of patents affect QBRELIS investment prospects?
Patent expiration exposes QBRELIS to generic competition, sharply reducing exclusivity-driven revenues and margins. Investors should consider the declining sales trend and potential for market saturation.

3. Are there emerging markets where QBRELIS can sustain or grow sales?
Yes, in regions with underdeveloped generic infrastructure or limited access to newer agents, such as parts of Africa and Asia, QBRELIS may retain a niche or preferred status.

4. What regulatory strategies could prolong QBRELIS’s market presence?
Developing new formulations, seeking additional indications, or leveraging regulatory pathways like biosimilar development can help extend marketability.

5. Will cannabinoid-based or novel antiemetics impact QBRELIS sales?
Future trends favor new, targeted therapies, including cannabinoids and other adjuncts, which could further diminish QBRELIS’s market share if adopted broadly.

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References

[1] Helsinn Group, product information, Aloxi, 2003.
[2] U.S. Food and Drug Administration (FDA), Approval history for palonosetron, 2003.
[3] IQVIA, Market dynamics report, 2023.
[4] European Medicines Agency (EMA), Marketing authorization and patent expiration data, 2022.
[5] GlobalData, Oncology drug market projections, 2023.

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