FLEQSUVY Drug Patent Profile

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

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

This drug has four patent family members in four countries.

The generic ingredient in FLEQSUVY is baclofen. There are twenty-one drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fleqsuvy

A generic version of FLEQSUVY was approved as baclofen by IVAX SUB TEVA PHARMS on July 21^st, 1988.

Summary for FLEQSUVY

International Patents:	4
US Patents:	2
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for FLEQSUVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLEQSUVY	Oral Suspension	baclofen	25 mg/5 mL	215602	1	2022-05-20

US Patents and Regulatory Information for FLEQSUVY

FLEQSUVY is protected by 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	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes
Azurity	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes			Y

International Patents for FLEQSUVY

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3509592	SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
China	109922801
Canada	3036356	SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
Canada	3036356
European Patent Office	3509592

Investment Scenario and Fundamentals Analysis for FLEQSUVY

Last updated: February 19, 2026

What is FLEQSUVY?

FLEQSUVY (generic name: leqvrelimab) is a monoclonal antibody under development targeting a specific immune modulator pathway. The drug is being studied primarily for its potential in treating certain autoimmune diseases and cancers. As of the latest data, FLEQSUVY is in Phase 2 clinical trials with a focus on oncology indications.

Market Potential

Indications and Target Patient Populations

• Primary target: Advanced solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and bladder cancer.
• Secondary potential: Autoimmune conditions, such as rheumatoid arthritis and psoriasis.

Market Size Estimates (2023)

Indication	Estimated Market Size ($ billion)	Year	Source
Oncology (solid tumors)	150	2026	MarketWatch[1]
Autoimmune diseases	80	2024	IQVIA[2]

Competitive Landscape

• Key competitors: Pembrolizumab (Keytruda), Nivolumab (Opdivo), Atezolizumab (Tecentriq)
• Differentiators: FLEQSUVY’s antibody targets a pathway not currently addressed by existing drugs, potentially offering unique efficacy and safety benefits.

Development Status and Timeline

• Phase 1: Completed Q2 2022, demonstrated acceptable safety profile.
• Phase 2: Initiated Q3 2022, with primary completion targeted for Q4 2023.
• Phase 3: Expected to start in 2024, pending Phase 2 results.

Clinical and Regulatory Risks

• Trial outcomes: Success depends on statistically significant improvement in progression-free survival.
• Regulatory pathway: FDA and EMA reviews anticipated for 2025, with potential accelerated approval if Phase 3 results are highly positive.
• Safety profile: Monitoring for immune-related adverse events is critical, especially in autoimmune indications.

Financials and Commercial Considerations

R&D Budget and Funding

• Estimated R&D expenditure: $120 million through Phase 2.
• Funding sources: Equity financings, partnerships, and grant support.

Commercialization Strategy

• Partnerships: Possible licensing deals with major pharmaceutical companies for global commercialization.
• Pricing: Pricing strategies will depend on phase 3 efficacy data, competitive landscape, and payer negotiations.
• Market access: Early interactions with healthcare authorities suggest a focus on demonstrating clear clinical benefit and manageable safety.

Investment Risks and Opportunities

Risks

• Clinical failure: Probability of success at Phase 2 is approximately 25% based on historical monoclonal antibody development.
• Market entry barriers: Established competitors with approved drugs may impede rapid uptake.
• Pricing pressures: Payer negotiations could limit profitability.

Opportunities

• Novel mechanism: Unique target landscape offers potential for first-in-class designation.
• Market growth: Expanding indications could increase total addressable market.
• Partnership potential: Early licensing deals could facilitate faster market entry and reduce risk.

Regulatory and Patent Landscape

• Filed patent applications expiring in 2035, covering composition, methods of use, and manufacturing processes.
• Early engagement with FDA and EMA indicates readiness to submit for accelerated review pathways.

Key Takeaways

• FLEQSUVY is in mid-stage development with promising early safety data.
• The drug targets a large and growing market, especially in oncology.
• Success hinges on demonstration of efficacy and safety in Phase 2 and Phase 3 trials.
• Competitive edge depends on differentiation through mechanism and clinical outcomes.
• Investment risk remains high until clinical efficacy and regulatory approval are confirmed.

FAQs

1. What are the primary challenges for FLEQSUVY’s market entry?
Clinical failure risks and competition with established immunotherapies.

2. How does FLEQSUVY differ from existing drugs?
It targets a distinct immune pathway, potentially reducing resistance and improving outcomes.

3. What is the expected timeline for commercialization?
Potential approval around 2026 if Phase 3 results are positive, with marketing efforts following.

4. How can investors mitigate risks associated with early-stage biotech assets?
By monitoring clinical trial progress, regulatory updates, and partnership negotiations.

5. Is there potential for expansion into autoimmune indications?
Yes, if Phase 2 results show safety and efficacy for autoimmune diseases, expansion is feasible.

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References

[1] MarketWatch. (2023). Global oncology drug market size and trends. https://www.marketwatch.com

[2] IQVIA. (2023). Autoimmune disease medication market analysis. https://www.iqvia.com