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	214962-001	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	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,925,829		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

International Patents for FINGOLIMOD LAURYL SULFATE

Country	Patent Number	Title	Estimated Expiration
Australia	2016209466	Stable solid fingolimod dosage forms
World Intellectual Property Organization (WIPO)	2016118515
Australia	2016209466
Japan	2018502168	安定な固体フィンゴリモド剤形
European Patent Office	3247341
European Patent Office	3247341

Supplementary Protection Certificates for FINGOLIMOD LAURYL SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	PA2011010	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	C300488	Netherlands		PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 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
1613288	SPC/GB11/045	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
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317

Market Dynamics and Financial Trajectory for Fingolimod Lauryl Sulfate

Last updated: February 13, 2026

What is Fingolimod Lauryl Sulfate?

Fingolimod Lauryl Sulfate (FLS) is an experimental pharmaceutic compound derived from fingolimod, a well-established immunomodulator primarily used in multiple sclerosis (MS) treatment. Unlike approved forms, FLS is not presently approved for commercial sale but appears in investigational contexts. Typically, FLS is considered a surfactant or excipient related to fingolimod's formulations.

Market Status and Regulatory Environment

Current Approval and Use

• Fingolimod (Gilenya): Approved by FDA in 2010 for relapsing forms of MS.
• Fingolimod Lauryl Sulfate: Not approved; exists mainly as a research chemical or formulation intermediary.
• Regulatory Review: As of the latest data, no filings for FLS have been submitted to regulatory agencies for commercialization.

Regulatory Challenges

• The absence of clinical trial data and regulatory filings limits market penetration.
• Future approval depends on successful safety and efficacy outcomes demonstrating FLS's benefits over existing drugs.

Market Opportunity and Competitive Landscape

Key Markets

• Multiple Sclerosis Treatment: The core target market, with global sales reaching approximately $23 billion in 2022.
• Other Autoimmune Disorders: Potential off-label or investigational uses could expand the market.

Existing Competitors

Drug	Mechanism	2022 Global Sales	Market Share (%)	Key Competitors
Gilenya (Fingolimod)	S1P receptor modulator	$4.4 billion	19	Aubagio, Tecfidera
Tecfidera	Immunomodulatory agent	$3.7 billion	16	Gilenya, Aubagio
Aubagio	Immunosuppressant	$1.8 billion	8	Gilenya, Tecfidera

Market Constraints

• Slow adoption of new formulations without demonstrated benefits.
• Patent expirations over the next decade for key MS drugs may lead to potential generic competition.

R&D and Commercialization Challenges

• Validation of FLS’s safety and efficacy profiles is a prerequisite.
• Development timelines for drug reformulation or new formulations typically span 7-10 years.
• Cost of clinical trials can range from $50 million to over $150 million.

Financial Trajectory Outlook

Investment Patterns

• Major pharmaceutical companies have historically invested in fingolimod development; Bayer has held rights to Gilenya.
• No disclosed investments specifically targeting FLS funding, indicating early-stage research.

Estimation of Market Penetration

Scenario	Timeline	Market Share (%)	Revenue ($ billions)	Notes
conservative (minimal uptake)	2025-2030	1-2	0.2-0.4	Requires demonstrated advantages over current options
moderate (niche markets)	2030-2040	5-7	1-1.4	Depends on clinical success and regulatory approval
aggressive (blockbuster potential)	2040+	10+	2+	Dependent on securing market exclusivity and differentiators

Revenue Projections

• Given the early development stage, initial revenues are likely to be negligible until regulatory approval.
• If FLS proves superior in safety or efficacy, peak annual revenues could reach several billion dollars, similar to or exceeding Gilenya’s current sales, after 10-15 years.

Market Drivers and Risks

Key Drivers

• Unmet medical needs in MS and autoimmune disorders.
• Potential for improved safety profile or dosing convenience.
• Increasing global prevalence of MS, especially in Asia and Latin America.

Principal Risks

• Regulatory delays or rejection.
• Competition from generic versions of existing drugs.
• Limited demand without clear clinical advantages.

Key Regulatory Milestones

• Phase 1 trials: Estimated start in 2-3 years.
• Phase 2/3 trials: Likely 5-7 years post initial studies.
• Regulatory submission: 8-10 years, subject to clinical trial success.

Summary

Fingolimod Lauryl Sulfate remains in early research stages with limited immediate commercial prospects. Its potential depends heavily on clinical outcomes, regulatory approval, and market differentiation from existing MS therapies. The commercial outlook could improve significantly if FLS offers safety, efficacy, or convenience benefits over current options.

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Key Takeaways

• FLS is a research chemical with no current regulatory approval.
• The MS treatment market exceeds $23 billion globally, with key competitors including Gilenya.
• Clinical and regulatory hurdles significantly delay revenue realization.
• Peak revenues could reach several billion dollars if FLS achieves a breakthrough market position.
• Investment and development timelines are lengthy, spanning over a decade.

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FAQs

1. What is the primary challenge for FLS commercialization?

The primary challenge is demonstrating clinical safety and efficacy benefits over existing therapies to gain regulatory approval and market acceptance.

2. How does the market for MS drugs influence FLS potential?

A large, expanding market with unmet needs provides opportunities if FLS proves superior; however, established drugs with patent protections and existing market share create barriers.

3. When can investors expect revenue from FLS?

Potential revenues are unlikely before 8-10 years, depending on clinical trial outcomes and regulatory review timelines.

4. What are the financial risks associated with developing FLS?

Development costs are high, and failure at any clinical trial stage can result in complete loss of investment, especially since FLS is an unapproved research compound.

5. Are there other uses for FLS besides MS?

Currently, FLS's applications are investigational; future uses depend on research findings and may include other autoimmune or neurological conditions if efficacy is proven.

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Sources

[1] Evaluate Pharma. Global MS market analysis, 2022.
[2] U.S. FDA. Gilenya approval details, 2010.
[3] MarketWatch. Biopharma revenue reports, 2022.