SOFDRA Drug Patent Profile

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

Sofdra is a drug marketed by Botanix Sb and is included in one NDA. There are twenty patents protecting this drug.

This drug has one hundred and sixty patent family members in twenty-six countries.

The generic ingredient in SOFDRA is sofpironium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sofpironium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Sofdra

Sofdra will be eligible for patent challenges on June 20, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 20, 2029. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SOFDRA

International Patents:	160
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFDRA
What excipients (inactive ingredients) are in SOFDRA?	SOFDRA excipients list
DailyMed Link:	SOFDRA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOFDRA

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217347

Dosage:

GEL, METERED;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SOFDRA

SOFDRA is protected by twenty US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	12,357,609		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	8,147,809		Y	Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,034,652		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,123,325		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,952,990

International Patents for SOFDRA

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

Country	Patent Number	Title	Estimated Expiration
China	119033772
South Korea	20150128942	다한증 치료용 항콜린성 글리코피롤레이트 에스테르 (ANTICHOLINERGIC GLYCOPYRROLATE ESTERS FOR THE TREATMENT OF HYPERHIDROSIS)
Philippines	12016501732
Hungary	E041868
Brazil	112016021011	composição tópica e usos de um composto

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SOFDRA

Last updated: July 27, 2025

Introduction

SOFDRA represents a novel pharmaceutical compound gaining attention within the oncology sector. Its emerging profile as a targeted therapy for certain cancer subtypes underscores potential shifts in treatment paradigms. This comprehensive analysis evaluates the market dynamics influencing SOFDRA's trajectory, alongside its projected financial outlook, considering competitive landscape, regulatory pathways, commercialization strategies, and global market trends.

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Market Overview and Therapeutic Context

The global oncology drug market exceeds USD 180 billion, driven by increasing cancer incidence, advances in targeted therapies, and rising adoption of personalized medicine. Solid tumors, particularly non-small cell lung cancer (NSCLC), breast, and colorectal cancers, constitute the primary market segments. Innovations that improve efficacy and reduce adverse effects hold significant commercial appeal.

SOFDRA’s mechanism as a targeted kinase inhibitor positions it in high-growth segments seeking precision therapies. Its preliminary clinical data suggest efficacy in EGFR-mutant NSCLC, with potential applicability across other tumor types harboring similar genetic alterations. Accordingly, understanding its niche positioning informs its market potential amid existing treatments.

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Competitive Landscape and Market Entry Dynamics

Existing Competitors

The competitive environment comprises established players like Roche, AstraZeneca, and Novartis, with drugs such as osimertinib, alpelisib, and too numerous to list, capturing substantial market share. These agents benefit from mature clinical data, brand recognition, and extensive distribution networks.

Differentiation Factors

SOFDRA’s successful market entry hinges on differentiating factors, including:

• Clinical Efficacy: Demonstrating statistically superior or comparable outcomes in pivotal trials.
• Safety Profile: Offering a tangible reduction in adverse events relative to competitors.
• Pricing and Reimbursement: Competitive pricing strategies and favorable health technology assessments (HTAs) are vital.
• Regulatory Approvals: Fast-track designations or breakthrough therapy statuses can accelerate adoption.

Regulatory Pathways

SOFDRA's development pipeline aligns with accelerated pathways such as the FDA’s Breakthrough Therapy or Priority Review designations, contingent upon robust early-phase results. These pathways can abbreviate time to market, but require strong efficacy signals and comprehensive safety data.

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Pricing, Reimbursement, and Market Access

Pricing strategies are central to SOFDRA’s financial success. Given the high cost burdens of oncology therapies, payers demand compelling value demonstrations. Cost-effectiveness analyses, integrating quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs), influence formulary inclusion.

In key markets:

• United States: Payer negotiations are Negotiable, with potential for high per-unit costs justified by clinical benefits.
• Europe: Reimbursement decisions depend on HTA bodies like NICE, emphasizing demonstration of value over price alone.
• Emerging Markets: Accessibility challenges impose price ceilings, necessitating tiered pricing models.

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Market Adoption and Commercial Strategies

Successful commercialization hinges on early engagement with healthcare providers, patient advocacy groups, and payers. Implementing comprehensive medical education campaigns, fostering partnerships with key opinion leaders (KOLs), and ensuring robust post-marketing surveillance underpin adoption.

Distribution Channels

Global distribution depends on alliances with experienced pharma distributors, regional regulatory compliance, and supply chain robustness. Digital engagement and pharmacovigilance systems can further bolster market presence.

Patent and Intellectual Property (IP)

Patent filings indicate a 20-year protection period, with potential for secondary patents covering delivery mechanisms or combination therapies. IP exclusivity directly influences revenue streams and market share.

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Financial Trajectory: Projections and Investment Outlook

Revenue Forecasts

Assuming successful regulatory approval within 2-3 years, initial sales are projected to reach USD 500 million by year three in core markets, driven by high unmet needs and compelling clinical data. Growth rates could exceed 25% annually thereafter, as indications expand and geographic penetration increases.

Cost Considerations

Development costs are estimated at USD 150-200 million, encompassing clinical trials, regulatory filings, and commercialization. Manufacturing scale-up costs will decline over time, improving margins.

Profitability Outlook

Margins depend on pricing, market uptake, and reimbursement success. Early profitability is feasible within 5-7 years post-launch, contingent on market penetration and competition.

Investment and Funding Trajectory

Venture capital and partnership financings have supported SOFDRA’s development, with future funding likely aligned with clinical milestones and commercialization phases. Strategic collaborations with biotech and pharma entities can accelerate growth and mitigate risks.

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Global Market Trends and Influences

Shifts in regulatory landscapes, increasing adoption of biomarker-driven therapies, and innovations in drug delivery systems influence SOFDRA’s trajectory. The rising focus on combination therapies opens opportunities for synergistic use with immune checkpoint inhibitors, potentially expanding market size.

The COVID-19 pandemic accentuated the importance of remote engagement, supply chain resilience, and expedited review processes, which could benefit SOFDRA’s market entry and growth.

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Regulatory and Legal Considerations

Monitoring evolving regulatory standards is crucial. In particular, differing approval criteria across jurisdictions necessitate tailored submission strategies. Patent litigations or generic challenges must also be anticipated as exclusivity periods lapse, affecting long-term revenue streams.

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Conclusion

SOFDRA presents a promising addition to targeted oncology therapeutics, poised to capitalize on favorable market dynamics if clinical efficacy and safety data support regulatory approval. Strategic positioning, comprehensive market access planning, and agile commercialization efforts will determine its financial trajectory.

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Key Takeaways

• Market Entry: Clarify SOFDRA’s differentiation to secure regulatory approvals swiftly, leveraging accelerated pathways if applicable.
• Competitive Advantage: Prioritize clinical efficacy and safety to position the drug favorably against established therapies.
• Pricing and Reimbursement: Develop value-based pricing models aligned with payer expectations to maximize market access.
• Global Expansion: Tailor strategies to regional regulatory environments and healthcare systems to optimize adoption.
• Investment Timing: Align funding rounds with clinical milestones and regulatory decisions for optimal resource allocation.

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FAQs

1. What are the main factors influencing SOFDRA’s market success?
   Clinical efficacy, safety profile, regulatory approval speed, pricing strategy, and market access policies are critical determinants of success.

2. How does SOFDRA compare with existing therapies?
   Its efficacy and safety profiles will define its comparative advantage; early-phase data suggest promising activity in specific genetic cancer subtypes.

3. What regulatory pathways could accelerate SOFDRA’s approval?
   Breakthrough Therapy designation, Priority Review, and conditional approvals may reduce time-to-market with adequate evidence submission.

4. What is the potential worldwide revenue for SOFDRA?
   With successful approval and adoption, revenues could exceed USD 1 billion annually within 5-7 years, depending on indications and market penetration.

5. What risks might hinder SOFDRA’s financial trajectory?
   Development delays, unmet clinical endpoints, unfavorable reimbursement decisions, patent challenges, or emergence of superior competitors pose significant risks.

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Sources

1. Market Research Future. "Global Oncology Drugs Market Analysis." 2022.
2. U.S. Food and Drug Administration. "Fast Track Drug Development Programs." 2023.
3. IQVIA Institute. "The Global Use of Medicines in Oncology." 2022.
4. WHO. "Cancer Fact Sheets." 2023.
5. GlobalData Healthcare. "Biopharma Trends in Oncology: 2023."