FINGOLIMOD LAURYL SULFATE - Generic Drug Details

What are the generic sources for fingolimod lauryl sulfate and what is the scope of freedom to operate?

Fingolimod lauryl sulfate is the generic ingredient in one branded drug marketed by Cycle and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fingolimod lauryl sulfate has seven patent family members in seven countries.

One supplier is listed for this compound.

Summary for FINGOLIMOD LAURYL SULFATE

International Patents:	7
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINGOLIMOD LAURYL SULFATE
What excipients (inactive ingredients) are in FINGOLIMOD LAURYL SULFATE?	FINGOLIMOD LAURYL SULFATE excipients list
DailyMed Link:	FINGOLIMOD LAURYL SULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FINGOLIMOD LAURYL SULFATE

Constraining patent/regulatory exclusivity:

10,925,829

Dosage:

TABLET, ORALLY DISINTEGRATING;ORAL

^*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.

Pharmacology for FINGOLIMOD LAURYL SULFATE

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for FINGOLIMOD LAURYL SULFATE

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AE	Sphingosine-1-phosphate (S1P) receptor modulators
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FINGOLIMOD LAURYL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,925,829		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,925,829		Y

International Patents for FINGOLIMOD LAURYL SULFATE

Country	Patent Number	Title	Estimated Expiration
Japan	2018502168	安定な固体フィンゴリモド剤形
Taiwan	201642842	Stable solid FINGOLIMOD dosage forms
Canada	2974375	FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Australia	2016209466
China	107530301	稳定的固体芬戈莫德剂型 (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Japan	2018502168	安定な固体フィンゴリモド剤形

Supplementary Protection Certificates for FINGOLIMOD LAURYL SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C300497	Netherlands		PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406	SPC/GB11/026	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1613288	PA2011010,C1613288	Lithuania		PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011-03-17 EU/1/11/677/002, 2011-03-17 EU/1/11/677/003, 2011-03-17 EU/1/11/677/004 20110317
0627406	11C0021	France		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
1613288	2011/027	Ireland		PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317

Market Dynamics and Financial Trajectory for Fingolimod Lauryl Sulfate

Last updated: July 28, 2025

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Introduction

Fingolimod Lauryl Sulfate represents an emerging derivative within the therapeutic landscape of immunomodulatory drugs. Its development, market adoption, and financial potential are influenced by complex dynamics spanning clinical efficacy, regulatory pathways, competitive positioning, and patent considerations. This article analyzes the current and projected market trends, the financial trajectory for this compound, and strategic implications for stakeholders.

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Overview of Fingolimod Lauryl Sulfate

Fingolimod Lauryl Sulfate is a formulation variant of fingolimod, a sphingosine-1-phosphate receptor modulator approved for treating relapsing forms of multiple sclerosis (MS). While fingolimod's initial patent expired in 2019 in several jurisdictions, proprietary derivatives like the Lauryl Sulfate formulation are under exploration to optimize pharmacokinetics, reduce adverse effects, or extend patent protection.

The rationale for this derivative involves leveraging the drug delivery benefits conferred by surfactant-based formulations, potentially enhancing bioavailability and patient compliance.

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Market Dynamics

Demand Drivers

1. Prevalence of Multiple Sclerosis:
   MS remains a significant neurological disorder worldwide, with an estimated prevalence of approximately 2.8 million cases globally [1]. The demand for effective disease-modifying therapies (DMTs) like fingolimod is driven by increasing incidence rates, particularly in developing countries.

2. Growing Competition:
   Multiple oral DMTs, including ozanimod and siponimod, have entered or are advancing in the market, intensifying competition (e.g., Novartis's Gilenya). The development of fingolimod formulations like Lauryl Sulfate aims to carve niche advantages, such as improved pharmacokinetics or reduced side effects.

3. Regulatory Incentives:
   Patent extensions and orphan drug designations, if applicable, could incentivize accelerated development and commercialization, further boosting market demand.

Supply and Manufacturing Challenges

Formulation stability, scalable synthesis routes, and cost-effectiveness of the Lauryl Sulfate derivative influence market penetration. Manufacturing complexities associated with surfactant-based formulations could modulate supply chains and pricing strategies.

Pricing and Reimbursement Landscape

Pricing strategies influence adoption rates; premiums for formulations claiming improved safety or efficacy face scrutiny from payers. Reimbursement policies in major markets (e.g., US, EU) heavily depend on clinical trial outcomes and comparative effectiveness data.

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Financial Trajectory

Research and Development Expenditure

Development of fingolimod Lauryl Sulfate involves substantial R&D investment, encompassing preclinical trials, clinical phases, and regulatory filings. The industry standard for novel derivatives is approximately $1-2 billion from discovery to commercialization [2].

Regulatory Pathway and Market Entry

Regulatory approval hinges on demonstrating bioequivalence, safety, and efficacy. Fast-track or priority review designations can expedite approval, impacting time-to-market and revenue streams.

Revenue Potential

• Market Penetration: A successful formulation could secure a significant share of the MS DMT market, especially if it offers measurable improvements over existing formulations.
• Pricing Power: Enhanced safety profiles or improved bioavailability allow for premium pricing, potentially yielding higher profit margins.
• Lifecycle Management: Patent protections extending into the 2030s, coupled with formulations patenting, could sustain revenue streams and defuse generic competition.

Competitive Outlook and Financial Risks

Generic competitors post-patent expiry, or alternative therapies, could erode market share. The success of the formulation depends on differentiation and clinical validation. Investment risks include clinical failure, regulatory delays, and reimbursement challenges.

Projected Financial Trends

Based on market growth estimates and assuming successful product development:

• 2023-2025: Significant R&D investments with limited revenue realization.
• 2026-2030: Market entry, approximately 10-20% market share adoption, with revenue projections ranging from $300 million to $1 billion annually, contingent on efficacy, safety, and marketing strategies.
• Post-2030: Patent expiration risks and increased generic competition could lead to revenue decline unless product differentiation sustains premium positioning.

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Strategic Considerations

• Intellectual Property: Securing robust patents for formulation and use cases enhances financial stability.
• Clinical Validation: Demonstrating clear advantages in safety or efficacy can support pricing and reimbursement.
• Global Expansion: Targeting emerging markets with increasing MS prevalence presents growth opportunities.
• Partnerships: Licensing agreements or collaborations with large pharmaceutical firms can mitigate risk and expedite commercialization.

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Conclusion

Fingolimod Lauryl Sulfate's market success and financial trajectory hinge on regulatory approval, clinical performance, and competitive differentiation. While substantial R&D investments are required, strategic patenting and market positioning could enable lucrative returns over a decade. Stakeholders must continuously monitor market trends, clinical developments, and regulatory landscapes to optimize decision-making.

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Key Takeaways

• The development of fingolimod Lauryl Sulfate aligns with ongoing efforts to optimize existing MS therapies through formulation innovation.
• Market demand remains robust, driven by increasing MS prevalence, but faces rising competition from newer agents.
• Financial success depends on achieving regulatory approval, securing patent protections, and demonstrating clinical advantages.
• Revenue projections suggest potential for significant returns post-market entry, provided differentiation and reimbursement hurdles are addressed.
• Strategic partnerships and global market expansion are crucial for maximizing financial outcomes.

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FAQs

1. How does fingolimod Lauryl Sulfate differ from standard fingolimod formulations?
Fingolimod Lauryl Sulfate employs surfactant-based excipients to potentially improve drug solubility, absorption, or reduce side effects, offering strategic formulation advantages over conventional fingolimod.

2. What are the primary regulatory challenges for this derivative?
Demonstrating bioequivalence, safety, and efficacy through rigorous clinical trials are necessary; formulation complexity may require additional stability and bioavailability studies, influencing approval timelines.

3. Can fingolimod Lauryl Sulfate extend patent life?
Yes, novel formulations can be patented separately from the original molecule, providing extended exclusivity and market protection, depending on jurisdictional patent laws.

4. What are potential market entry barriers in emerging markets?
Pricing, reimbursement policies, clinical adoption, and local regulatory requirements pose challenges that can delay or limit market penetration.

5. What factors are most likely to influence its financial success?
Clinical superiority, regulatory approval speed, patent protection, manufacturing scalability, reimbursement strategies, and competitive landscape will significantly impact financial outcomes.

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Sources

1. World Health Organization. (2022). Multiple Sclerosis Fact Sheet.
2. DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.