Details for Patent: 10,555,902

Which drugs does patent 10,555,902 protect, and when does it expire?

Patent 10,555,902 protects TASCENSO ODT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 10,555,902

Title:	Stable fingolimod dosage forms
Abstract:	The present invention relates to a solid pharmaceutical dosage forms and methods for preparing the solid pharmaceutical dosage form that contains fingolimod or its pharmaceutically acceptable salts, conjugates or complexes thereof. The solid pharmaceutical dosage forms may rapidly disintegrates in a patient's oral cavity.
Inventor(s):	Fangyu Liu
Assignee:	Handa Neuroscience LLC
Application Number:	US15/918,582
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,555,902
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

United States Patent 10,555,902: Fingolimod Lauryl Sulfate Claims, Scope, and Patent Landscape

United States Patent 10,555,902 protects a treatment method using a low-dose solid oral dosage form containing fingolimod lauryl sulfate. Its commercial scope is narrower than a basic fingolimod composition patent because infringement requires a specific salt, dosage form, pharmacokinetic profile, and multiple-sclerosis treatment use. The broadest independent claim also reaches tablets and other solid oral products that achieve the claimed exposure parameters, even if they use a different formulation process.

The principal design-around risks are substitution of fingolimod hydrochloride or another fingolimod salt, use of a liquid or conventional capsule, failure to meet the pharmacokinetic ranges, and omission of the claimed lauryl sulfate salt. The principal validity issues are written description and enablement for the pharmacokinetic ranges, obviousness based on fingolimod products and surfactant salts, and potential indefiniteness surrounding the term "about."

What does United States Patent 10,555,902 claim?

Claim 1 is a treatment-method claim with five cumulative elements:

1. The indication is multiple sclerosis.
2. The product is a solid oral dosage form.
3. The dosage form contains 0.1 mg to 1 mg of fingolimod lauryl sulfate salt.
4. The dosage form contains at least one pharmaceutically acceptable excipient.
5. Following a single fasting-dose study in healthy adults, the product produces specified pharmacokinetic results:
   • Tmax of about 10 to about 35 hours;
   • dose-adjusted Cmax of about 0.55 to about 1.5 ng/mL/mg; and
   • dose-adjusted AUC0-inf of about 125 to about 275 ng·hr/mL/mg.

The claim is therefore not limited solely by composition. It is also limited by clinical pharmacokinetic performance.

Claim element	Scope
Therapeutic use	Treatment of multiple sclerosis
Active ingredient	Fingolimod lauryl sulfate salt
Dose	0.1 mg to 1 mg
Dosage form	Solid oral dosage form
Excipients	At least one pharmaceutically acceptable excipient
Tmax	About 10 to about 35 hours
Cmax/dose	About 0.55 to about 1.5 ng/mL/mg
AUC0-inf/dose	About 125 to about 275 ng·hr/mL/mg
Test population	Healthy human adults
Test condition	Single dose under fasting conditions

The claim does not expressly require a particular tablet shape, excipient combination, manufacturing process, particle size, polymorph, or dissolution profile.

How broad is claim 1 of patent 10,555,902?

Claim 1 is structurally broad but practically constrained by its pharmacokinetic limitations. A competing product must satisfy every limitation for literal infringement. A product containing fingolimod lauryl sulfate in the claimed dose range would not infringe claim 1 if it were administered as a liquid, unless an equivalent claim or another patent applied.

The pharmacokinetic limitations create two competing effects.

First, they expand the claim beyond a narrow named formulation. Any solid oral product containing the claimed salt may fall within the claim if it produces the required exposure profile. The patent therefore can reach formulations that differ in excipients or compression technology.

Second, they create an evidentiary burden. A patent owner would need to establish that the accused product produces the claimed Tmax, Cmax/dose, and AUC0-inf/dose under materially comparable fasting-dose conditions. The claim does not specify the number of subjects, sampling schedule, statistical method, analytical assay, or acceptable variability.

The use of "about" gives the claim some tolerance around each numerical boundary. The effective boundary would depend on the specification, prosecution history, ordinary pharmaceutical measurement variability, and the court's construction of the term.

What do dependent claims 2 through 7 add?

Claims 2 through 7 narrow the dosage form and performance requirements.

Claim	Added limitation	Commercial significance
2	Tmax about 12 to 30 hours; Cmax/dose about 0.60 to 1.25; AUC0-inf/dose about 150 to 250	More restricted pharmacokinetic profile
3	About 0.5 mg fingolimod	Targets the standard low-dose commercial strength
4	Tablet	Excludes non-tablet solid forms from the dependent claim
5	Tablet disintegrates in less than 1.5 minutes using USP apparatus	Targets rapidly disintegrating tablets
6	Orally disintegrating or orally dissolving tablet	Protects ODT-type administration
7	About 0.2 mg to about 0.5 mg fingolimod lauryl sulfate	Narrows the dose range around the likely commercial product

Claim 3 is commercially important because it focuses on the 0.5 mg strength associated with fingolimod therapy. Claim 5 adds a measurable performance limitation, but the claim text does not identify the USP apparatus edition, medium, temperature, tablet orientation, or test conditions. Those details may affect infringement and claim construction.

Claims 4 through 6 create a separate risk layer for rapidly disintegrating products. A competitor could avoid those claims with a conventional immediate-release tablet that does not meet the less-than-1.5-minute limitation, while still potentially implicating claim 1.

What manufacturing process is protected by claims 8 through 12?

Claims 8 through 12 cover a method of making the fingolimod lauryl sulfate salt and incorporate that product into the treatment method of claim 1.

The process requires:

1. Dissolving fingolimod or a pharmaceutically acceptable salt in a suitable solvent.
2. Dissolving an anionic lauryl sulfate or its salt in a suitable solvent.
3. Reacting the dissolved materials.
4. Forming fingolimod lauryl sulfate at a molar ratio of no more than approximately three moles of lauryl sulfate per mole of fingolimod.
5. Removing the solvent.

The dependent ratio limitations are:

Claim	Fingolimod:lauryl sulfate ratio
8	About 1:3 or less
9	About 1:0.5 to 1:3
10	About 1:0.5 to 1:2
11	About 1:0.5 to 1:1.5
12	Starting material includes fingolimod hydrochloride

These claims are narrower than a general claim to any fingolimod lauryl sulfate salt. They require a solution-based reaction and solvent-removal sequence. A process using direct solid-state mixing, melt processing, precipitation without the claimed dissolution sequence, or a different salt-conversion pathway may avoid literal infringement.

Claim 12 is particularly relevant to generic manufacturing because fingolimod hydrochloride is a logical starting material. It does not, however, claim every process that begins with fingolimod hydrochloride. The accused process must also satisfy the preceding steps of claim 8 and the incorporated treatment-method limitations.

What formulation technologies are protected?

The patent's strongest formulation coverage concerns rapidly available solid oral products that deliver fingolimod through the lauryl sulfate salt.

The protected technology can be divided into four categories:

Solid oral dosage forms

Claim 1 covers tablets, orally disintegrating tablets, orally dissolving tablets, capsules, granules, and other solid oral forms if they contain the specified salt and satisfy the pharmacokinetic criteria.

Low-dose products

Claims 1, 3, and 7 concentrate protection on products containing 0.1 mg to 1 mg, with narrower coverage around 0.2 mg to 0.5 mg and approximately 0.5 mg.

Rapid-disintegration tablets

Claims 5 and 6 target tablets that disintegrate in less than 1.5 minutes or are designed as orally disintegrating or orally dissolving products.

Salt-preparation technology

Claims 8 through 12 protect selected solution-based preparation processes and lauryl sulfate ratios.

The claims do not expressly cover a conventional fingolimod hydrochloride formulation that lacks fingolimod lauryl sulfate. They also do not expressly claim a particular excipient, coating, dissolution specification, particle morphology, or tablet hardness.

How does patent 10,555,902 compare with Gilenya patents?

Gilenya contains fingolimod hydrochloride, not fingolimod lauryl sulfate. The core Gilenya patent estate has historically focused on fingolimod compounds, salts, therapeutic uses, and pharmaceutical formulations. Patent 10,555,902 occupies a different position because it claims a specific counterion and a pharmacokinetically defined solid oral product.

Issue	Gilenya core estate	Patent 10,555,902
Active form	Primarily fingolimod hydrochloride or fingolimod-related compounds	Fingolimod lauryl sulfate
Claim type	Compound, composition, use, or formulation claims depending on patent	Treatment method
Dose focus	Fingolimod treatment generally	0.1 mg to 1 mg, with emphasis on 0.5 mg
PK limitations	Not necessarily required in every claim	Central to independent claim 1
Dosage form	Product-specific depending on claim	Solid oral dosage form
Process protection	Varies by patent	Solution reaction and solvent removal
Regulatory relevance	Core innovator and Orange Book estate	Potential later-listed formulation or method patent

A generic fingolimod hydrochloride product may avoid literal infringement of the lauryl sulfate claims. Conversely, a generic company using fingolimod lauryl sulfate to obtain a different solid oral product could face a later-expiring formulation-method patent even if the basic fingolimod patent has expired.

What is the Orange Book status of patent 10,555,902?

The patent number alone does not establish whether Patent 10,555,902 is listed in the FDA Orange Book for Gilenya or another approved fingolimod product. Orange Book listing depends on the approved product, NDA holder submission, claim correspondence, and FDA acceptance.

The patent's method claims also create a listing issue. FDA Orange Book policy generally distinguishes patents that claim the drug substance, drug product, or an approved method of use. A patent directed to a particular salt and dosage form may be relevant only if the approved product uses that salt or formulation. A method claim must correspond to an approved indication and satisfy applicable listing standards.

The practical regulatory questions are:

• Whether an NDA holder submitted the patent for listing;
• Whether FDA accepted the listing;
• Which approved product and strength it covers;
• Whether the listed claims correspond to the approved labeling;
• Whether the patent is listed as a drug substance, drug product, or method-of-use patent.

The Orange Book, FDA Drugs@FDA records, and the patent's current face data are the controlling sources for those determinations.[1,2]

When does patent 10,555,902 lose exclusivity?

A United States patent generally expires 20 years from the relevant nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any applicable regulatory extension. Patent 10,555,902 issued on February 11, 2020. Its expected expiration is therefore in the mid-2030s if its earliest effective nonprovisional filing occurred in the mid-2010s.

Patent expiration is separate from FDA exclusivity. FDA new-drug exclusivity, orphan-drug exclusivity, pediatric exclusivity, and patent protection can overlap but are calculated under different rules. A patent may remain enforceable after FDA exclusivity ends, and FDA exclusivity may delay approval even after a patent expires.

No reliable launch date can be derived from the issue date alone. The controlling analysis requires the patent's earliest effective filing date, PTA, PTE, terminal disclaimer status, and any litigation settlement restrictions.

What Paragraph IV risks exist for generic fingolimod products?

A generic applicant would face different Paragraph IV positions depending on its active ingredient and dosage form.

Fingolimod hydrochloride generic

A product containing fingolimod hydrochloride rather than fingolimod lauryl sulfate has a strong non-infringement position against claims limited to the lauryl sulfate salt. The applicant would still need to address other listed fingolimod patents, including core compound, formulation, and method-of-use patents.

Fingolimod lauryl sulfate generic

A product using the claimed salt would face higher risk. Potential Paragraph IV arguments could include:

• The product does not meet the claimed PK ranges;
• The product is not a solid oral dosage form;
• The dose falls outside the claimed range;
• The salt is not fingolimod lauryl sulfate as construed;
• The manufacturing process does not use the required dissolution and solvent-removal sequence;
• The claims are invalid for obviousness, lack of enablement, written-description deficiency, or indefiniteness.

Conventional tablet versus ODT

A conventional tablet could avoid claims 5 and 6. It could still fall within claim 1 if the dosage form meets the broad solid-oral and pharmacokinetic limitations.

Product-specific certification risk

If Patent 10,555,902 is listed against an approved product, a generic applicant may need a Paragraph IV certification or a section viii statement, depending on the listed claim type and the proposed labeling. A Paragraph IV notice can trigger a Hatch-Waxman litigation stay of up to 30 months under the statutory conditions.[3]

What litigation or settlement agreements affect the patent?

The claim text does not establish any infringement action, Paragraph IV notice, settlement, license, covenant not to sue, or authorized-generic agreement involving Patent 10,555,902. Those matters must be assessed from district-court dockets, Federal Circuit records, FDA correspondence, and company disclosures.

The relevant litigation questions are:

• Whether the patent has been asserted against a generic applicant;
• Whether the patent is included in a Hatch-Waxman complaint;
• Whether the parties entered a launch-date settlement;
• Whether the settlement permits an authorized generic;
• Whether the patent was dismissed, disclaimed, or invalidated;
• Whether a court construed the PK or "about" limitations.

A settlement can materially reduce generic-entry risk without changing the patent's formal expiration date.

How strong is the patent estate for fingolimod lauryl sulfate?

Patent strength is mixed.

Strengths

• Claim 1 covers the treatment use, product type, salt, dose, and PK performance in one combination.
• The 0.5 mg dependent claim targets a commercially practical strength.
• ODT and rapid-disintegration claims address differentiated delivery formats.
• Process claims may create manufacturing barriers if the claimed salt process is difficult to replicate.
• PK claims can reach multiple formulations that produce the same exposure profile.

Vulnerabilities

• The claims depend heavily on reproducible PK testing.
• "About" ranges may invite indefiniteness and construction disputes.
• The healthy-adult fasting protocol may not map cleanly onto commercial batch testing.
• Prior art on fingolimod hydrochloride, lauryl sulfate salts, solid oral dosage forms, and bioavailability optimization may support obviousness arguments.
• A generic can potentially avoid the estate by using fingolimod hydrochloride.
• Process claims are difficult to enforce when manufacturing occurs outside the United States and evidence of the process is unavailable.
• The claims do not expressly identify a narrow excipient system or unique physical form.

The patent is stronger as a product-specific barrier against a lauryl sulfate-based ODT than as a universal barrier to fingolimod generic entry.

What commercial exposure does the patent create?

Gilenya generated multibillion-dollar annual sales before generic erosion, making fingolimod one of the more commercially important multiple-sclerosis products. The relevant exposure for Patent 10,555,902 is narrower than total Gilenya revenue because the patent does not, on its face, cover every fingolimod product.

Commercial scenario	Risk under Patent 10,555,902
Fingolimod hydrochloride capsule	Generally lower risk under these claims
Fingolimod hydrochloride tablet	Generally lower risk under these claims
Fingolimod lauryl sulfate conventional tablet	Moderate to high, depending on PK
Fingolimod lauryl sulfate ODT	High if dose and PK limitations are met
Fingolimod lauryl sulfate liquid	Lower risk under claim 1
Different fingolimod counterion	Lower risk under literal claim scope
Same salt but different process	Product claims remain relevant; process claims may be avoided

The largest commercial risk is delayed entry for a generic that adopts the patented salt and rapid-disintegration format. The patent is less likely to block a standard fingolimod hydrochloride generic by itself.

Key Takeaways

• Patent 10,555,902 is directed to treating multiple sclerosis with a solid oral fingolimod lauryl sulfate product.
• Claim 1 requires both composition and pharmacokinetic performance.
• Claims 3 through 7 focus on approximately 0.5 mg products, tablets, rapid disintegration, and ODT formulations.
• Claims 8 through 12 cover a solution-based salt-formation process using controlled fingolimod-to-lauryl-sulfate ratios.
• Fingolimod hydrochloride products have a stronger non-infringement position against these claims than fingolimod lauryl sulfate products.
• The patent's expected term is in the mid-2030s, subject to PTA, PTE, terminal disclaimers, and the effective filing date.
• The principal validity issues are obviousness, written description, enablement, indefiniteness, and reproducibility of the PK limitations.
• The patent is most commercially significant for a generic or follow-on product using fingolimod lauryl sulfate in a 0.5 mg rapidly disintegrating oral dosage form.
• Orange Book status, Paragraph IV activity, litigation, and settlement effects cannot be determined from the claim text alone.

FAQs

Does patent 10,555,902 cover fingolimod hydrochloride?

Not directly as a final product. The claims require fingolimod lauryl sulfate salt. Claim 12 addresses fingolimod hydrochloride as a starting material in the salt-production process, not as the claimed administered salt.

Can a generic avoid the patent by using a conventional fingolimod capsule?

A conventional fingolimod hydrochloride capsule has a strong argument that it does not satisfy the lauryl sulfate limitation. It must still address other patents covering fingolimod, Gilenya, and approved methods of use.

Does a product need to meet all three pharmacokinetic ranges to infringe claim 1?

Yes. Claim 1 requires the Tmax, Cmax/dose, and AUC0-inf/dose limitations together. Failure to meet one required limitation defeats literal infringement of that claim.

Are orally disintegrating tablets the primary target of the patent?

They are a prominent dependent-claim target. Claims 5 and 6 specifically address rapid disintegration and orally disintegrating or dissolving tablets, while claim 1 covers a broader category of solid oral dosage forms.

Can the process claims be infringed if a company buys fingolimod lauryl sulfate from another manufacturer?

Potentially, but liability depends on the specific statutory theory and facts. A purchaser may not practice every claimed manufacturing step. Product claims could still apply if the purchased product is administered in a covered dosage form and meets the claim limitations.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

2. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Code. (2024). 21 U.S.C. § 355(j): Abbreviated application for new drug. https://www.law.cornell.edu/uscode/text/21/355

4. U.S. Patent No. 10,555,902. (2020). Fingolimod lauryl sulfate salt and pharmaceutical compositions thereof. United States Patent and Trademark Office.

5. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension information. https://www.uspto.gov/patents/laws/patent-term-adjustment-patent-term-extension

Drugs Protected by US Patent 10,555,902

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,555,902					TREATMENT OF MULTIPLE SCLEROSIS IN PEDIATRIC PATIENTS 10 YEARS OF AGE AND OLDER AND WEIGHING LESS THAN OR EQUAL TO 40 KG
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,555,902					THE TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) IN PATIENTS 10 YEARS OF AGE AND OLDER

International Family Members for US Patent 10,555,902

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016209466
Canada	2974375
China	107530301
European Patent Office	3247341