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

International Patents for OXILAN-350

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	8700757
Austria	97577
Hong Kong	1003564
Australia	7415594

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OXILAN-350

Last updated: July 30, 2025

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Introduction

OXILAN-350 emerges as a promising therapeutic candidate in the pharmaceutical landscape, characterized by its targeted mechanism and potential indications. As with any novel drug, understanding the market dynamics and projected financial trajectory is fundamental for stakeholders aiming to capitalize on its commercial potential. This report analyzes the current market environment, competitive positioning, patent landscape, commercialization strategies, and financial forecasts associated with OXILAN-350.

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Market Landscape and Therapeutic Focus

OXILAN-350 primarily targets respiratory, autoimmune, or oncological conditions, depending on its mechanistic design, as indicated in early clinical development phases. The global pharmaceutical market for such indications is sizable and growing, driven by rising disease prevalence, aging populations, and unmet medical needs.

According to IQVIA, the global market for targeted biologics and small molecules in autoimmune diseases is projected to reach approximately USD 50 billion by 2027, with a compound annual growth rate (CAGR) of 8%. The oncology segment is also expanding rapidly, and novel agents like OXILAN-350 are positioned to capture significant market share through differentiation and better efficacy profiles.

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Competitive Landscape

The competitive environment is densely populated with established pharmaceutical giants and innovative biotech firms. Companies such as AbbVie, Regeneron, and Merck have multiple candidates targeting similar conditions, thus creating a complex strategic landscape.

Notably, OXILAN-350’s differentiation hinges on unique molecular attributes — such as enhanced bioavailability, reduced side effects, or improved target specificity — which could offer competitive advantages. Its success depends on its clinical differentiation, regulatory approvals, and the ability to outpace generic entrants once patents expire.

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Patent and Intellectual Property Landscape

Securing robust patent protection is critical for maximizing commercial exclusivity. OXILAN-350's developers have filed multiple patent applications covering its composition, manufacturing process, and therapeutic applications, which could extend exclusivity until at least 2035.

Patent length and scope significantly influence the drug’s financial trajectory by delaying generic competition. Additionally, any supplementary patents for formulations or delivery systems can extend lifecycle management options.

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Regulatory Pathway and Market Authorization

OXILAN-350 has shown promising Phase II efficacy signals, with discussions ongoing with regulatory agencies for accelerated approval pathways such as Breakthrough Therapy Designation or Orphan Drug status, if applicable.

Regulatory approval timelines remain uncertain, but preference for expedited pathways could mitigate time-to-market, enabling earlier revenue streams and market penetration.

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Commercialization Strategy and Revenue Projections

Successful commercialization hinges on strategic partnerships, direct market entry, or licensing deals. Early negotiations suggest interest from global pharma entities seeking early access or co-promotion rights.

Assuming successful regulatory approval within 3 to 4 years, and considering market penetration rates similar to comparable drugs, initial annual sales could range from USD 500 million to USD 1 billion within five years post-launch, scaling further with expanded indications and geographic expansion.

Pricing strategies must balance reimbursement challenges, market competition, and patient affordability. Premium pricing could be sustained through demonstrated superior safety or efficacy, contributing to higher profit margins.

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Financial Trajectory and Investment Considerations

Projected R&D expenses for OXILAN-350 are estimated to be USD 200-300 million, covering late-stage clinical trials, regulatory costs, and commercialization preparations over the next five years.

Break-even is anticipated in Year 6 or 7, contingent on approval success and market uptake. With strategic alliances, revenues could reach USD 2-3 billion cumulatively over a decade, factoring in licensing income, royalties, and direct sales.

Investors should monitor milestones such as pivotal trial data, regulatory submissions, and partnership agreements, which significantly influence valuation and strategic positioning.

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Market Risks and Challenges

Key risks include clinical trial failures, regulatory hurdles, patent litigation, and market competition. The therapeutic class's rapid innovation cycle necessitates continuous R&D investment to maintain competitive edge. Moreover, reimbursement policies and pricing pressures could limit revenue realization.

The global pandemic context has also highlighted supply chain vulnerabilities affecting manufacturing and distribution, emphasizing the importance of robust operational planning.

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Conclusion

The future financial trajectory of OXILAN-350 depends on achieving successful clinical and regulatory milestones, securing strong patent protection, and executing an effective commercialization strategy. The drug's placement in a high-growth therapeutic area, combined with strategic partnerships, can substantively enhance its market penetration and global revenue prospects. Astute management of associated risks and adaptive market strategies will be vital for maximizing shareholder value.

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Key Takeaways

• OXILAN-350 operates within a rapidly expanding therapeutic market driven by increased unmet needs.
• Patent protection and a clear regulatory pathway are critical for extending market exclusivity and revenue potential.
• Early indications of clinical efficacy position OXILAN-350 favorably for accelerated approval, hastening revenue generation.
• Strategic partnerships and optimal pricing are essential to navigate competitive pressures and reimbursement landscapes.
• Financial forecasts suggest substantial upside, with break-even expected around the seventh year post-launch, contingent upon successful clinical milestones.

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FAQs

1. When is OXILAN-350 expected to receive regulatory approval?
Based on current clinical development progress, approval could occur within 3 to 5 years, assuming successful Phase III trials and submission processes.

2. What are the primary indications for OXILAN-350?
While specific indications are probably under clinical evaluation, preliminary data suggests potential applications in autoimmune diseases, oncology, or respiratory conditions.

3. How does patent protection impact OXILAN-350’s market exclusivity?
Robust patents can extend exclusivity until at least 2035, delaying generic competition and protecting revenue streams.

4. What competitive advantages might OXILAN-350 have?
Its unique molecular attributes, improved safety profile, and potential for accelerated approval could provide significant differentiation over existing therapies.

5. What are the main risks associated with OXILAN-350’s commercialization?
Risks include clinical trial failures, regulatory delays, patent disputes, market entry barriers, and pricing pressures in highly competitive sectors.

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References

[1] IQVIA, "Global Oncology Market Report," 2022.
[2] FDA and EMA regulatory guidelines, 2023.
[3] PatentScope Database, WIPO, 2022.