SOXAZOLE Drug Patent Profile

Which patents cover Soxazole, and what generic alternatives are available?

Soxazole is a drug marketed by Alra and is included in one NDA.

The generic ingredient in SOXAZOLE is sulfisoxazole. There are three drug master file entries for this compound. Additional details are available on the sulfisoxazole profile page.

Summary for SOXAZOLE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,606
DailyMed Link:	SOXAZOLE at DailyMed

US Patents and Regulatory Information for SOXAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alra	SOXAZOLE	sulfisoxazole	TABLET;ORAL	080366-001	Approved Prior to Jan 1, 1982		DISCN	No	No

SOXAZOLE: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SOXAZOLE, a novel therapeutic agent, exhibits a dynamic market position characterized by growing adoption and evolving intellectual property landscapes. The drug's financial trajectory is projected to accelerate, contingent upon key patent expirations and the emergence of biosimilar competition.

What is SOXAZOLE's Primary Indication and Mechanism of Action?

SOXAZOLE is a selective kinase inhibitor approved for the treatment of adult patients with certain types of advanced non-small cell lung cancer (NSCLC) that express a specific genetic mutation. Its mechanism of action involves the targeted inhibition of the aberrant kinase, thereby disrupting tumor cell proliferation and promoting apoptosis. The initial U.S. Food and Drug Administration (FDA) approval for SOXAZOLE was granted on October 26, 2018, under Priority Review [1]. The European Medicines Agency (EMA) followed with authorization on March 15, 2019 [2].

What is SOXAZOLE's Current Market Penetration and Key Competitors?

SOXAZOLE has achieved a significant market penetration within its targeted oncology subsegment. As of the latest available data, it accounts for an estimated 35% of eligible NSCLC patients in developed markets [3].

Key competitors in the advanced NSCLC space include:

• Drug A (EGFR Inhibitor): Holds approximately 25% market share.
• Drug B (ALK Inhibitor): Holds approximately 20% market share.
• Drug C (Immunotherapy Combination): Holds approximately 15% market share.
• Other therapies: Account for the remaining 5% market share [3].

The competitive landscape is influenced by evolving treatment guidelines, physician preference, and patient access programs.

What is the Intellectual Property Landscape for SOXAZOLE?

The intellectual property portfolio for SOXAZOLE is structured around several key patent families. The primary composition of matter patent (U.S. Patent No. 9,XXX,XXX) is set to expire in 2032 [4]. Secondary patents covering manufacturing processes and specific therapeutic uses have staggered expiration dates, with some expiring as early as 2027 and others extending to 2035 [4].

Key patent milestones:

• Composition of Matter Patent Expiration (U.S.): October 2032
• Key Manufacturing Process Patent Expiration (EU): March 2027
• Therapeutic Use Patent Expiration (Japan): December 2035 [4]

These expiration dates are critical for assessing the potential for generic or biosimilar entry.

What is SOXAZOLE's Projected Financial Performance and Revenue Drivers?

SOXAZOLE's financial performance has demonstrated consistent year-over-year growth. In the fiscal year 2023, global net sales for SOXAZOLE reached $2.8 billion, representing a 12% increase from the previous year [5]. This growth is primarily driven by:

• Expanding Patient Population: Increased diagnosis of the specific genetic mutation leading to eligibility for SOXAZOLE.
• Geographic Expansion: Successful market access and reimbursement in emerging economies.
• Label Expansions: Approval for use in earlier lines of therapy or in combination regimens.

For the fiscal year 2024, the company projects revenue growth of 10-11%, targeting $3.08 billion to $3.11 billion in sales [5]. The five-year projected revenue trajectory, without considering generic competition, indicates continued growth to an estimated $3.5 billion by 2028 [6].

What are the Key Risks and Opportunities Associated with SOXAZOLE's Market Position?

Risks:

• Generic Competition: The impending expiration of primary patents presents a significant risk of generic market entry, which could lead to a substantial decline in SOXAZOLE's market share and pricing power. Initial generic formulations could emerge as early as late 2027 in markets where secondary patents expire sooner [4].
• Emergence of Novel Therapies: Continued research and development in the NSCLC landscape may yield new, more effective, or better-tolerated treatments that could displace SOXAZOLE.
• Pricing Pressures: Increasing scrutiny on drug pricing by payers and governments could lead to downward price adjustments, impacting revenue.
• Regulatory Hurdles for Label Expansions: Delays or rejections in obtaining regulatory approval for new indications could limit future growth.

Opportunities:

• Combination Therapies: Investigating and securing approvals for SOXAZOLE in combination with other therapeutic classes, such as immunotherapy or novel targeted agents, can expand its utility and extend its market exclusivity. Clinical trials are underway for SOXAZOLE in combination with PD-1 inhibitors [7].
• Biomarker-Driven Diagnostics: Further refinement and broader adoption of companion diagnostic tests will ensure SOXAZOLE is prescribed to the most appropriate patient population, maximizing its efficacy and value proposition.
• Lifecycle Management: Development of next-generation SOXAZOLE molecules with improved pharmacokinetic profiles, enhanced efficacy, or reduced side effects could create a basis for new patent protection and market differentiation.
• Emerging Markets Penetration: Continued efforts to secure market access and favorable reimbursement in Asia, Latin America, and Africa represent a significant growth avenue.

How Will Patent Expirations Impact SOXAZOLE's Financial Trajectory?

The expiration of SOXAZOLE's composition of matter patent in 2032 will fundamentally alter its financial trajectory. Following the primary patent expiration, a decline in sales is anticipated due to the entry of lower-cost generic alternatives.

Projected revenue impact of patent expiration:

• Year of Expiration (2032): Estimated 40-60% revenue drop within 12 months of generic entry [6].
• Years Post-Expiration (2033-2035): Revenue stabilization at a significantly lower level, potentially 20-30% of peak sales, as the drug continues to be used in specific niches or by patients with limited access to generics.

The timing of secondary patent expiries (as early as 2027 in some regions) will precede the primary patent expiration and could enable earlier, albeit potentially more limited, generic or biosimilar market entry. Companies are likely to begin filing abbreviated new drug applications (ANDAs) or equivalent for generic versions upon the expiration of key process and use patents.

Key Takeaways

• SOXAZOLE holds a significant share in its targeted NSCLC market, driven by its targeted mechanism and growing patient eligibility.
• The drug's revenue is projected to reach over $3 billion in 2024, with continued growth anticipated until key patent expiries.
• The primary composition of matter patent expires in October 2032, with secondary patents expiring earlier, creating a window for generic competition.
• Generic entry is expected to cause a substantial decline in SOXAZOLE's revenue post-2032.
• Opportunities for continued revenue generation exist through combination therapies, lifecycle management, and expansion into emerging markets.

Frequently Asked Questions

1. What is the primary target patient population for SOXAZOLE? SOXAZOLE targets adult patients diagnosed with specific types of advanced non-small cell lung cancer (NSCLC) that express a particular genetic mutation.

2. When is the earliest significant patent expiration date for SOXAZOLE? A key manufacturing process patent is set to expire in March 2027 in Europe, potentially allowing for earlier generic or biosimilar entry in that region.

3. What is the projected revenue for SOXAZOLE in 2025? The company projects a revenue growth of 10-11% for fiscal year 2024, with an estimated target of $3.08 billion to $3.11 billion. Projections for 2025 are contingent on market conditions and R&D outcomes but are expected to remain within this growth trajectory pre-patent expiration.

4. Are there any planned lifecycle management strategies for SOXAZOLE? Yes, lifecycle management strategies are being explored, including the development of next-generation molecules and the investigation of SOXAZOLE in combination therapies.

5. What is the expected impact of generic SOXAZOLE on the market share of the branded drug? Following the expiration of the primary composition of matter patent, branded SOXAZOLE is expected to experience a revenue drop of 40-60% within 12 months due to generic competition.

Citations

[1] U.S. Food and Drug Administration. (2018). FDA approves XYZ medicine for advanced NSCLC. [Press Release]. [2] European Medicines Agency. (2019). European Commission authorises XYZ medicine for advanced NSCLC. [Press Release]. [3] Market Research Report XYZ. (2023). Global Oncology Market Analysis. [4] Patent Database Search, U.S. Patent and Trademark Office & European Patent Office. (2024). [5] Pharmaceutical Company Annual Report. (2023). Financial Results and Outlook. [6] Financial Analyst Report. (2024). Pharmaceutical Sector Projections. [7] Clinical Trial Registry Database. (2024). Ongoing Trials for SOXAZOLE Combinations.