fingolimod lauryl sulfate - Profile

What are the generic drug 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.

Summary for fingolimod lauryl sulfate

International Patents:	7
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fingolimod lauryl sulfate

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.

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

International Patents for fingolimod lauryl sulfate

Country	Patent Number	Title	Estimated Expiration
Australia	2016209466
Canada	2974375
China	107530301
European Patent Office	3247341
Japan	2018502168
Taiwan	201642842
World Intellectual Property Organization (WIPO)	2016118515

Supplementary Protection Certificates for fingolimod lauryl sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C 2011 005	Romania		PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
0627406	2011020	Ireland		PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
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
1613288	2011C/030	Belgium		PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288	C20110013 00043	Estonia		PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011

Fingolimod Lauryl Sulfate: Patent, Market, and Investment Fundamentals Snapshot

Last updated: April 24, 2026

What is fingolimod lauryl sulfate and why does it matter?

Fingolimod lauryl sulfate is a derivative/salt form used to improve drug solubility, formulation performance, and delivery relative to base fingolimod. It is developed and marketed as a distinct pharmaceutical ingredient identity versus fingolimod (free base). In investment terms, salt/derivative products can create:

• Formulation-specific IP (salt preparation, polymorph/crystal form, solid-state forms, manufacturing process)
• Product-life extension in branded neurologic disease indications where fingolimod derivatives are positioned against the existing oral standard

Economic relevance: the derivative’s value depends on (1) whether it delivers measurable clinical or exposure advantages versus fingolimod itself, (2) whether regulators accept it as a distinct therapeutic product or as a formulation change, and (3) the strength and enforceability of derivative-specific claims.

What is the regulatory and commercial context for fingolimod derivatives?

Fingolimod is approved globally as oral therapy for relapsing forms of multiple sclerosis. Investment mapping for fingolimod lauryl sulfate depends on whether it is positioned as:

• a standalone active ingredient in a marketed product, or
• an internal development line supporting improved oral exposure or formulation stability

Commercial implication: if fingolimod lauryl sulfate is not the registered API in a major marketed product, investor returns typically come from licensing, manufacturing scale-up contracts, or formulation IP monetization rather than direct revenue from prescription volumes.

What is the patent/IP landscape for fingolimod lauryl sulfate?

A complete, defensible patent landscape requires jurisdiction-level claim mapping (US/EU/CN/JP/WO families), legal status, claim scope, and remaining term. This requires specific filings and bibliographic identifiers for fingolimod lauryl sulfate.

No specific patent family set, jurisdictional legal status, priority dates, publication numbers, or expiry dates are provided in the input. Under operating constraints, a complete and accurate IP investment assessment cannot be produced without those data.

What are the core investment drivers for fingolimod lauryl sulfate?

With fingolimod lauryl sulfate, the investment thesis usually rests on four pillars:

1) Regulatory path and clinical differentiation

Key questions for funding and valuation:

• Does the derivative show improved bioavailability/exposure (PK endpoints) that translate into dosing and tolerability advantages?
• Does it support better stability for scale-up (less degradation, improved shelf life)?
• Does it enable a more favorable formulation (capsule/tablet performance, solubility at physiological pH)?

Where differentiation is primarily formulation-level, regulatory approvals often hinge on comparability and stability datasets rather than full pivotal clinical programs. That shifts value from clinical success probability to CMC execution risk and regulatory acceptability.

2) Manufacturability and CMC risk

Salt/derivative economics depend on:

• yield, crystallization control, and reproducibility
• impurity profile control (process-related impurities, residual solvents)
• scalable manufacturing with tight specifications

CMO suitability and cost of goods (COGS) can decide whether the derivative is commercially viable.

3) IP enforceability beyond the base compound

Derivative value rises when the patent estate covers:

• salt formation methods (specific reagents/ratios/conditions)
• isolation/purification processes
• solid-state forms (polymorph/crystal forms)
• composition-of-matter claims that survive obviousness challenges

If IP is limited to weak process claims or expires early, generic/competitive entry risk increases.

4) Competitive positioning

Fingolimod sits in a neurologic category where:

• newer S1P modulators and alternatives compete on safety, dosing, and convenience
• payer coverage and neurologist preference determine uptake

A derivative must outperform fingolimod on at least one durable dimension: exposure, safety signal mitigation via formulation, adherence, or tolerability management.

How should investors underwrite market potential for this derivative?

Without product-level facts (registered API, approved label, launch timeline, sales channel data, and pricing), an investment underwriting framework cannot be completed to required standards. Under the constraints, no sales forecasts, uptake curves, or valuation math can be generated.

That said, the underwriting logic for fingolimod lauryl sulfate typically uses:

• segmentation by geography (where fingolimod is reimbursed and where derivative uptake is plausible)
• formulation adoption (whether switching from existing fingolimod products is clinically and commercially justified)
• time-to-approval and time-to-COGS advantage

In practice, investors treat the derivative as an asset that can earn value via:

• royalty/licensing if the derivative is used by a major label
• margin uplift if manufacturing cost drops or if differentiation allows premium pricing
• litigation leverage if the IP estate blocks competitors from using identical salt forms

What are the risk factors that can break the thesis?

IP and legal

• weak claim coverage for salt identity, solid-state forms, or manufacturing methods
• enforceability limits due to prior art combining fingolimod with common counterions
• generic substitution risk if regulatory bodies treat it as an interchangeable formulation

CMC and regulatory

• uncontrolled polymorph transitions affecting bioavailability or stability
• impurity excursions during scale-up
• rejection risk due to inadequate solid-state characterization or stability design

Commercial

• payer resistance to reformulated versions without clear clinical benefit
• rapid competitive switching toward newer oral therapies or infusion alternatives
• tender dynamics in key markets that compress margins

Valuation read-through: what metrics would drive deal terms?

A complete deal valuation requires data that is not present in the input. Still, the metrics that materially drive valuation for derivatives like fingolimod lauryl sulfate are:

• Remaining patent term on composition and solid-state claims
• Regulatory status (approved label, jurisdiction coverage, and any reference product interchangeability determinations)
• CMC cost (COGS delta versus fingolimod)
• Stability performance (shelf life extension and packaging requirements)
• IP defensibility (novelty and non-obviousness strength over known salt formation art)

Investment strategy: where the upside typically comes from

For an asset like fingolimod lauryl sulfate, upside often comes from one of three paths:

1) Derivative commercialization: direct sales under an approved label tied to the salt form
2) Licensing/manufacturing: monetization of salt formation processes, solid-state forms, or CMC package
3) Platform rights: extending IP to other derivatives or delivery systems based on the same solid-state control and synthesis chemistry

Key Takeaways

• Fingolimod lauryl sulfate is a fingolimod salt/derivative investment concept where value hinges on CMC execution, regulatory acceptability, and IP enforceability around the salt identity and solid-state forms.
• An investment-grade assessment requires jurisdiction-specific patent family data and product/regulatory status facts; those details are not provided in the input, so a complete patent-to-term-to-risk evaluation cannot be produced here.
• The investment case is strongest where the derivative delivers measurable exposure or stability advantages and where the IP estate covers composition-of-matter or robust solid-state claims with meaningful remaining life.

FAQs

1) Is fingolimod lauryl sulfate the same as fingolimod?

No. It is a derivative/salt form, and investment value depends on whether that change creates enforceable, demonstrable advantages and whether regulators treat it as a distinct product.

2) What typically drives investor confidence for salt-form derivatives?

Claim strength that covers the salt/solid-state form and a CMC package that reliably reproduces the same physical form with controlled impurities.

3) Does a salt form require full clinical trials?

Often it can follow a reduced pathway if exposure and comparability are established, but this depends on regulatory requirements and whether differentiation is clinically meaningful.

4) What is the biggest downside risk?

Loss of exclusivity through weak or easily designed-around IP, or inability to consistently control solid-state and impurity profiles at commercial scale.

5) Where can returns come from if sales are limited?

From licensing, manufacturing supply agreements, and royalties tied to process/solid-state rights rather than from large direct prescription revenue.

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References

[1] EMA. Guideline on the development of medicinal products for use in self-medication. European Medicines Agency. https://www.ema.europa.eu/
[2] FDA. Guidance for Industry: ANDA Submissions - Amendments to Abbreviated New Drug Applications. U.S. Food and Drug Administration. https://www.fda.gov/
[3] ICH. ICH Q8, Q9, Q10 Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality System. International Council for Harmonisation. https://www.ich.org/