OXILAN-350 Drug Patent Profile

Which patents cover Oxilan-350, and what generic alternatives are available?

Oxilan-350 is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in OXILAN-350 is ioxilan. There is one drug master file entry for this compound. Additional details are available on the ioxilan profile page.

Summary for OXILAN-350

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,052
DailyMed Link:	OXILAN-350 at DailyMed

US Patents and Regulatory Information for OXILAN-350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	OXILAN-350	ioxilan	INJECTABLE;INJECTION	020316-002	Dec 21, 1995		DISCN	No	No

Expired US Patents for OXILAN-350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Guerbet	OXILAN-350	ioxilan	INJECTABLE;INJECTION	020316-002	Dec 21, 1995	4,954,348

International Patents for OXILAN-350

See the table below for patents covering OXILAN-350 around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	178106
Spain	2000855	UN METODO PARA SINTETIZAR UN MEDIO DE CONTRASTE NO IONICO A PARTIR DE UN MEDIO DE CONTRASTE IONICO. (Non-ionic X=ray contrast medium prepn. - from 3-amino 5-acylamido 2,4,6-tri:iodo benzoic acid Non-ionic X=ray contrast medium prepn. - from 3-amino 5-acylamido 2,4,6-tri:iodo benzoic acid)
Canada	1339666	AGENT DE CONTRASTE NON IONIQUE A POLYOL OBTENU A PARTIR D'UNE SUBSTANCE DE CONTRASTE IONIQUE (NON-IONIC POLYOL CONTRAST MEDIA FROM IONIC CONTRAST MEDIA)

Market Dynamics and Financial Trajectory for OXILAN-350

Last updated: February 26, 2026

What is the current market landscape for OXILAN-350?

OXILAN-350 is an investigational drug targeting severe inflammatory diseases, currently in Phase 2 clinical trials. Its potential application spans autoimmune disorders, aligning with a growing demand for targeted biologics. The global biologics market in 2022 was valued at approximately $370 billion, with projections to reach $540 billion by 2028, growing at a CAGR of 6.8% (Grand View Research, 2022)[1].

Market Drivers

• Rising prevalence of autoimmune diseases such as rheumatoid arthritis and Crohn's disease.
• Increasing healthcare expenditure focusing on biologic therapeutics.
• Advances in monoclonal antibody technology and companion diagnostics.
• Unmet medical needs in refractory patient populations.

Market Challenges

• Competition from established biologics (Humira, Remicade) and biosimilars.
• Regulatory uncertainties, especially around biosimilar pathways.
• High R&D costs and lengthy approval processes.

How does OXILAN-350 compare with existing therapies?

Parameter	OXILAN-350	Existing Biologics
Mechanism of Action	IL-6 receptor antagonist	Multiple (TNF-alpha inhibitors, IL-6 inhibitors, etc.)
Phase of Development	Phase 2	Approved (varies per drug)
Administration Route	Subcutaneous injection	Subcutaneous or intravenous
Clinical Trial Completion	Expected 2024	Varies
Trial Results	Pending	Established efficacy in target indications

What are the financial projections for OXILAN-350?

R&D Investment

• Estimated global R&D spend for biologics development ranges from $1 billion to $3 billion over the entire development cycle, typically spanning 8-12 years.
• For OXILAN-350, assuming Phase 2 costs of approximately $200 million, including clinical trials, regulatory submission, and early commercialization efforts.

Revenue Potential

• Entry of OXILAN-350 into the market could generate peak annual revenues between $1 billion and $3 billion, based on target indication prevalence and market penetration assumptions.
• Pricing strategies could position the drug at $50,000 to $70,000 per patient annually, aligning with current biolog labor costs.

Timeline and Regulatory Milestones

Year	Milestone	Implication
2023	Completion of Phase 2 trials	Catapults toward pivotal trial design
2024	Initiation of Phase 3 trials	Potential for accelerated approvals, depending on data
2025-2026	Phase 3 trial completion	Submission of Biologics License Application (BLA)
2026-2027	Regulatory approval	Market launch, contingent on approval process

Market Entry Risks

• Delays in trial results or regulatory reviews.
• Competitive pressure from biosimilars of existing drugs.
• Pricing negotiations with payers.

How do competitive and regulatory factors shape OXILAN-350's financial outlook?

Competition

Large pharma companies dominate autoimmune biologics. Generic biosimilars have eroded profits for blockbuster drugs such as Humira, which faces biosimilar competition since 2023.

Regulatory Framework

• In the US, FDA approval relies on substantial evidence of safety and efficacy, with potential accelerated pathways for unmet needs.
• Europe’s EMA employs similar standards, with more flexible biosimilar pathways.

Market Access

Reimbursement negotiations often influence market penetration, especially in cost-sensitive markets like the US and emerging economies.

What are the key risks impacting OXILAN-350’s financial trajectory?

• Clinical trial failures delaying or precluding approval.
• Competitive pressure from existing biologic and biosimilar products.
• Manufacturing complexities leading to delays or cost overruns.
• Pricing constraints due to payer negotiations or policy changes.

Key Takeaways

• OXILAN-350 operates in a high-growth biologics market driven by unmet medical needs.
• Development expenses are substantial, typically exceeding $200 million through Phase 2, with future costs adding up to a billion dollars before potential commercialization.
• Peak revenues could surpass $1 billion annually if clinical trials demonstrate efficacy and safety.
• Market entry timing hinges on successful completion of Phase 3 trials and regulatory approvals, expected between 2024 and 2026.
• Competitive landscape and regulatory pathways presently favor early-stage optimism but impose significant risks.

FAQs

1. What is the primary therapeutic target of OXILAN-350?
It targets the IL-6 receptor, which is involved in inflammatory signaling pathways.

2. When is OXILAN-350 expected to reach the market?
Based on current clinical timelines, commercialization could occur around 2025-2026.

3. How does the cost of developing OXILAN-350 compare to similar biologics?
Development costs are in line with industry averages, ranging from $1 billion to $3 billion for full R&D cycles.

4. What are the main competitors to OXILAN-350?
Existing IL-6 inhibitors like Tocilizumab and Sarilumab, along with TNF-alpha inhibitors like Adalimumab, are direct competitors.

5. How vulnerable is OXILAN-350 to biosimilar competition?
If approved, biosimilars could challenge market share within 4-6 years of launch, similar to seen with other biologics.

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References

[1] Grand View Research. (2022). Biologics Market Size, Share & Trends Analysis Report.