Details for Patent: 11,141,400

Which drugs does patent 11,141,400 protect, and when does it expire?

Patent 11,141,400 protects HETLIOZ and HETLIOZ LQ and is included in two NDAs.

This patent has one hundred and fifty-three patent family members in twenty-three countries.

Summary for Patent: 11,141,400

Title:	Method of treatment
Abstract:	One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.
Inventor(s):	Marlene Michelle Dressman, Mihael H. Polymeropoulos, Paolo Baroldi
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US16/800,611
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,141,400
Patent Claim Types: see list of patent claims	Use;

United States Patent 11,141,400: Tasimelteon Food-Effect Claims, Scope and Patent Landscape

U.S. Patent No. 11,141,400 protects a narrow method of administering 20 mg of tasimelteon without food to patients with circadian-rhythm or sleep disorders. Its commercial relevance is concentrated in the FDA-approved Hetlioz regimen, where food can delay exposure and reduce peak plasma concentration. The patent does not claim tasimelteon itself, a tablet composition, a formulation, or a manufacturing process. It claims the clinical administration instruction and associated fasting conditions.

The patent is strongest against a generic label that expressly directs patients to take 20 mg tasimelteon without food. Its enforceability and practical value depend on Orange Book listing, the scope of any approved generic label, induced-infringement evidence, and the validity of the food-effect limitation.

What does U.S. Patent 11,141,400 claim?

The independent claim covers a method with five required elements:

1. A patient has a circadian rhythm disorder or sleep disorder.
2. The patient receives tasimelteon orally.
3. The dose is an effective dose of 20 mg per day.
4. Tasimelteon is administered without food.
5. The purpose is to avoid a delayed Tmax, a decreased Cmax, or both, caused by administration with food.

Claim 1 is therefore a method-of-use claim directed to pharmacokinetic management. It is not a broad claim to treating insomnia or Non-24 Disorder with tasimelteon.

Claim	Added limitation	Practical effect
1	Oral 20 mg/day tasimelteon without food for a circadian-rhythm or sleep-disorder patient	Core food-effect administration claim
2	Patient is instructed to take tasimelteon without food	Captures prescribing, labeling, counseling, or patient-instruction conduct
3	Patient has a circadian rhythm disorder	Removes the broader sleep-disorder category
4	Disorder is Non-24 Disorder	Most directly aligned with Hetlioz's original approval
5	No food for at least 30 minutes before administration	Shortest fasting interval
6	No food for at least one hour before administration	Matches the principal FDA labeling instruction
7	No food for at least 1.5 hours before administration	More restrictive fasting condition
8	No food for at least two hours before administration	More restrictive fasting condition
9	No food for at least 2.5 hours before administration	More restrictive fasting condition
10	No food for at least three hours before administration	Narrowest fasting condition

The dependent claims do not change the dosage, route, or active ingredient. They progressively narrow the required pre-dose food restriction.

What is the scope of the 20 mg tasimelteon claim?

Claim 1 is limited to 20 mg per day. It does not expressly cover:

• Doses below 20 mg;
• Doses above 20 mg;
• Non-daily dosing;
• Intravenous, subcutaneous, transdermal, or other nonoral administration;
• A tasimelteon formulation independent of its use;
• Administration with food;
• A generic patient's use if the product label omits the fasting instruction;
• Pharmacokinetic outcomes unrelated to Tmax or Cmax.

The claim uses the phrase "effective dose," but then fixes the dose at 20 mg/d. The effective-dose language therefore does not give the claim unlimited dosage flexibility. A product administered at 20 mg once daily is the principal infringement risk profile.

The claim also requires administration "without food." That limitation is central. A product label that instructs patients to take tasimelteon without food is materially more significant than a product label that merely permits administration with or without food.

Does the patent cover Hetlioz?

Yes, the claims are directed to the manner in which Hetlioz is administered rather than to the tasimelteon molecule or a specific Hetlioz formulation.

Hetlioz contains tasimelteon and is approved for use in adults with Non-24-Hour Sleep-Wake Disorder. The FDA prescribing information directs administration of 20 mg once daily before bedtime and without food. The label also describes a food effect involving delayed Tmax and reduced Cmax, which corresponds closely to the limitations in U.S. Patent 11,141,400.[1]

The patent has a particularly direct relationship to the original Non-24 indication because:

• Claim 4 expressly names Non-24 Disorder.
• The commercial dose is 20 mg once daily.
• The FDA label contains the no-food instruction.
• The labeled pharmacokinetic rationale tracks the patent's delayed-Tmax and decreased-Cmax language.

The patent does not, however, exclusively protect the Hetlioz brand. A generic product using the same active ingredient and dosage can create infringement exposure even if its trade name is different.

What is the FDA regulatory status of tasimelteon?

Hetlioz capsules

The FDA approved Hetlioz on June 3, 2014, for treatment of Non-24-Hour Sleep-Wake Disorder in totally blind individuals.[2] The approved regimen is 20 mg once daily before bedtime and without food.

Hetlioz LQ

The FDA later approved Hetlioz LQ, an oral suspension formulation of tasimelteon, for the same general therapeutic category and for nighttime sleep disturbances in Smith-Magenis syndrome. The liquid product is commercially relevant because it may have separate formulation and listing considerations from the capsule product.

Regulatory significance for Patent 11,141,400

The patent's core method maps most directly to:

• 20 mg tasimelteon;
• Oral administration;
• Bedtime administration;
• A no-food instruction;
• Non-24 Disorder and related sleep disorders.

The FDA label is therefore an important infringement and validity document. It can support an argument that the claimed administration method is clinically relevant, but it can also provide prior-art and written-description evidence concerning the known food effect.

What patents protect tasimelteon and Hetlioz?

Tasimelteon's patent estate includes multiple categories of rights, not all of which have the same generic-blocking value.

Patent category	Typical subject matter	Relevance to generic entry
Compound patents	Tasimelteon molecule and related chemical structures	Potentially strongest if unexpired, but generally earlier-expiring
Treatment patents	Use for Non-24, circadian rhythm disorders, or sleep disorders	Can support method-of-use litigation
Food-effect patents	Administration without food to avoid altered Tmax or Cmax	Directly relevant to a label carrying the fasting instruction
Formulation patents	Capsules, oral suspensions, excipients, release characteristics	Relevant to the specific dosage form
Manufacturing patents	Processes for producing tasimelteon or intermediates	May create supply-chain barriers but usually does not block ordinary ANDA approval by itself
Pediatric or later-indication patents	Age-specific use or Smith-Magenis syndrome	May have limited blocking value if the generic omits a protected use

Patent 11,141,400 is in the food-effect and administration-method category. It should be analyzed separately from any earlier compound patent and from formulation patents covering Hetlioz capsules or Hetlioz LQ.

How strong is the patent estate for U.S. Patent 11,141,400?

Strengths

The patent has several commercial strengths:

• It tracks the approved 20 mg regimen.
• The FDA label expressly includes the no-food instruction.
• Claim 4 directly covers Non-24 Disorder.
• Claim 2 can reach patient instructions and prescribing conduct.
• Claims 5 through 10 create fallback positions with defined fasting intervals.
• The claimed pharmacokinetic consequences are objectively measurable through Tmax and Cmax data.

Weaknesses

The estate also has material limitations:

• The claims are method claims, not product claims.
• The no-food limitation may be vulnerable to anticipation or obviousness arguments if the food effect and fasting instruction were known before the relevant filing date.
• Claims 5 through 10 may be difficult to prove if the actual patient behavior is not documented.
• A generic applicant may seek a label that omits the patented indication or uses a carve-out strategy.
• A patient's failure to follow the label can complicate proof of direct infringement.
• The phrase "avoiding a delayed Tmax, a decreased Cmax, or both" may generate claim-construction disputes over whether the claimed result must actually occur or whether the administration method is sufficient.

The claims are commercially strong when the generic label reproduces the branded fasting instruction. They are less powerful when the generic label omits or modifies that instruction and the branded sponsor must rely on induced infringement or off-label-use evidence.

When does U.S. Patent 11,141,400 expire?

U.S. Patent 11,141,400 issued on October 12, 2021. Its term is governed by the patent family's earliest effective nonprovisional filing date, subject to patent-term adjustment and any other statutory modification under 35 U.S.C. §§ 154 and 156.[3]

The patent is generally associated with an expected expiration in the mid-2030s, approximately 2034, rather than with the 2020s expiration dates associated with earlier tasimelteon rights. The legally operative date is the USPTO term calculation, including any patent-term adjustment. An Orange Book listing may display a corresponding expiration date and use code for the approved product.

The patent does not receive a separate 20-year term merely because it issued in 2021. Patent issuance date and patent expiration date are different concepts.

What is the Orange Book status of Patent 11,141,400?

Orange Book relevance depends on whether the patent is listed against the applicable Hetlioz or Hetlioz LQ NDA and whether the listing includes an approved-use code. FDA regulations permit listing of patents that claim the drug substance, drug product, or an approved method of using the drug.[4]

For this patent, the relevant Orange Book analysis is:

Orange Book question	Analysis
Is this a drug-substance patent?	No. The claims do not claim tasimelteon as a chemical compound.
Is this a drug-product patent?	No apparent composition or dosage-form limitation appears in the quoted claims.
Is this a method-of-use patent?	Yes.
Can it be listed against an NDA?	Potentially, if the claims correspond to an approved use or administration method.
Is an approved-use code important?	Yes. The code determines the scope of a generic applicant's certification obligations.
Does listing prove validity?	No. Listing is an FDA administrative action, not a judicial determination of validity or infringement.

A generic applicant facing an Orange Book-listed method patent may submit a Paragraph IV certification asserting that the patent is invalid, unenforceable, or will not be infringed. The NDA holder can then file an infringement action within the statutory period, potentially triggering a 30-month stay of final approval under the Hatch-Waxman framework.[5]

What Paragraph IV challenges and generic entry risks exist?

The most likely generic strategies are label-dependent.

Strategy 1: Paragraph IV challenge

A generic applicant may challenge Patent 11,141,400 on the grounds that:

• The food effect was already disclosed;
• The no-food administration instruction was obvious;
• The claims lack adequate written description or enablement;
• The claims are indefinite;
• The generic product will not induce the claimed use;
• The claims are not infringed because the generic label does not require administration without food.

Strategy 2: Section viii carve-out

If the patent is listed only for a method of use and the protected method can be removed from the generic label, an ANDA applicant may use a section viii statement and carve the patented use from its labeling.[6]

This strategy is less effective if the no-food instruction is necessary for safe or effective use of the approved product, because removing the instruction could create regulatory and medical problems. It is also less effective if the instruction appears in general dosage-and-administration language rather than in a separable indication section.

Strategy 3: Label omission

A generic label could omit an express statement that tasimelteon must be taken without food. The sponsor could still argue induced infringement if the product's labeling, promotional materials, or expected use encourage administration in the patented manner. The strength of that argument would depend on the complete label and the factual record.

Strategy 4: Launch after an adverse patent ruling

A generic could launch if the patent is invalidated, held not infringed, delisted, expires, or becomes irrelevant to the approved generic label. A court's construction of "without food" and "avoiding a delayed Tmax, a decreased Cmax, or both" would be central.

Which companies are challenging Hetlioz patents?

The principal commercial risk comes from ANDA applicants seeking to market generic tasimelteon. Publicly actionable information should be separated into three categories:

1. An applicant has submitted an ANDA.
2. The applicant has submitted a Paragraph IV certification.
3. The NDA holder has filed an infringement action.

The existence of a generic applicant alone does not establish that Patent 11,141,400 is being challenged. A reliable assessment requires matching FDA Orange Book certifications with federal court dockets and complaints. Patent 11,141,400 should be reviewed alongside all other listed Hetlioz patents because a Paragraph IV case may challenge several patents in one action.

What patent litigation affects tasimelteon?

Tasimelteon litigation risk is likely to center on four issues:

Infringement

The plaintiff would need to show that the generic product's label or conduct leads to administration of 20 mg tasimelteon without food for a covered patient population. Claim 2 increases the importance of express patient instructions.

Claim construction

The court may need to construe:

• "without food";
• "effective dose is 20 mg/d";
• "avoiding a delayed Tmax";
• "a decreased Cmax";
• "resulting from the failure to administer tasimelteon without food."

Validity

The strongest prior-art attack is likely to focus on whether tasimelteon food-effect data and fasting instructions were already known. The patentee would respond that the claimed combination, clinical purpose, and dosing regimen were not disclosed or were not obvious as a whole.

Remedy and launch timing

A successful ANDA certification challenge could accelerate generic entry. A successful infringement action could delay approval until patent expiration or settlement-defined entry. A settlement may include a licensed entry date, an authorized generic arrangement, or restrictions on the generic label.

No settlement should be treated as commercially dispositive unless its entry date, authorized-generic provisions, and challenged patent scope are publicly documented.

What formulations are protected separately from the food-effect claims?

Patent 11,141,400 does not protect a particular capsule, tablet, or oral-suspension formulation in the quoted claims. Separate formulation patents may cover:

• Tasimelteon capsule composition;
• Oral-suspension concentration;
• Excipient combinations;
• Stability;
• Reconstitution;
• Container-closure systems;
• Taste masking or pediatric administration.

The distinction matters because a generic can avoid a formulation patent while still infringing a method patent, or can avoid the method patent while using a formulation that remains protected.

Hetlioz LQ creates a separate formulation and regulatory analysis. A generic capsule applicant and a generic oral-suspension applicant may face different patent listings, different bioequivalence requirements, and different litigation exposure.

How does Patent 11,141,400 compare with compound and formulation patents?

Issue	Patent 11,141,400	Compound patent	Formulation patent
Subject matter	Administration method	Chemical entity	Product composition
Infringement trigger	Use according to claimed regimen	Making, using, selling, or importing compound	Making or selling covered dosage form
Dependence on label	High	Lower	Moderate
Vulnerability to section viii carve-out	Potentially high	None	Usually none
Patient-behavior proof	Potentially relevant	Not generally relevant	Not generally relevant
Relevance to 20 mg no-food dosing	Direct	Indirect	Product-specific
Generic design-around options	Label or indication changes	Chemical redesign usually impractical	Reformulation or alternate excipients

The food-effect patent is more label-sensitive than a composition patent. Its value is highest when the approved label and generic label both direct the same conduct.

What geographic coverage does the patent provide?

U.S. Patent 11,141,400 provides rights in the United States and its territories under U.S. patent law. It does not automatically protect tasimelteon administration in Canada, Europe, Japan, or other markets.

International protection must be assessed by reviewing corresponding national applications and granted patents in the family. The existence of a U.S. patent does not establish enforceable foreign rights, identical claims, or matching expiration dates.

Manufacturing outside the United States can still create U.S. exposure if the patented method is practiced in the United States or if the product is imported under circumstances covered by U.S. patent law. A manufacturing patent, if separately granted, would require a different infringement analysis.

What revenue exposure is associated with generic entry?

Hetlioz revenue is exposed to generic substitution because:

• The active ingredient is a small molecule;
• The principal product is an oral dosage form;
• The commercial dose is standardized at 20 mg;
• FDA approval creates an ANDA pathway;
• Method claims can be vulnerable to label carve-outs.

The food-effect patent can delay or complicate generic entry but does not provide the same control as an unexpired composition patent. Revenue exposure should therefore be modeled against several scenarios:

Scenario	Commercial consequence
No ANDA challenge	Branded sales continue until generic approval
Paragraph IV settlement with delayed entry	Revenue declines at the agreed entry date
Successful patent challenge	Earlier generic launch and rapid price erosion
Section viii carve-out	Generic may launch for nonprotected uses
Label-induced infringement ruling	Generic launch may be delayed or restricted
Authorized generic launch	Price erosion begins, but Vanda may retain supply economics

Key Takeaways

• U.S. Patent 11,141,400 is a narrow tasimelteon method-of-use patent.
• Its core protection is 20 mg/day administered orally without food.
• Claim 4 directly covers Non-24 Disorder.
• Claims 5 through 10 define escalating pre-dose fasting intervals from 30 minutes to three hours.
• Claim 2 makes patient instructions and product labeling legally important.
• The patent does not claim tasimelteon itself, a formulation, or a manufacturing process.
• Its commercial strength depends heavily on Orange Book listing and generic-label language.
• The principal generic defenses are Paragraph IV invalidity or noninfringement arguments, section viii carve-outs, and omission of the fasting instruction.
• The expected patent term extends into approximately 2034, subject to the USPTO's official term calculation.
• Separate Hetlioz and Hetlioz LQ formulation, compound, and method patents must be analyzed before estimating generic launch timing.

FAQs About U.S. Patent 11,141,400 and Tasimelteon

Does Patent 11,141,400 cover tasimelteon taken with food?

No. The quoted claims require administration without food. Administration with food falls outside the express method limitation, although other patents or approved-use claims could apply.

Does a generic tasimelteon manufacturer infringe automatically?

No. Infringement depends on the generic label, the proposed use, the applicable patent claims, and whether the manufacturer induces administration according to the patented method.

Is a 20 mg tasimelteon dose without food required for Non-24 Disorder?

The FDA-approved Hetlioz regimen is 20 mg once daily before bedtime without food. The patent claims track that regimen but do not themselves establish FDA treatment requirements.[1]

Can a generic omit the words "without food" from its label?

A generic may seek a label carve-out or omission where permitted by the FDA and applicable patent law. The omission does not eliminate all infringement risk if other labeling or conduct encourages the patented administration method.

Does Patent 11,141,400 protect Hetlioz LQ?

The quoted claims do not require a capsule, tablet, or suspension. They could potentially reach oral tasimelteon administered at 20 mg/day without food, but product-specific formulation patents and NDA listings must be analyzed separately.

References

1. U.S. Food and Drug Administration. (2024). Hetlioz (tasimelteon) prescribing information.
2. U.S. Food and Drug Administration. (2014, June 3). FDA approves Hetlioz to treat non-24-hour sleep-wake disorder.
3. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation under 35 U.S.C. § 154.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. Hatch-Waxman Amendments, 21 U.S.C. § 355(j); 35 U.S.C. § 271(e).
6. U.S. Food and Drug Administration. (2024). ANDA submissions, patent certifications, and section viii statements.
7. United States Patent and Trademark Office. (2021, October 12). U.S. Patent No. 11,141,400, methods of administering tasimelteon.

Drugs Protected by US Patent 11,141,400

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,141,400					TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,141,400					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,141,400					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

International Family Members for US Patent 11,141,400

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013211878
Australia	2013211880
Australia	2013361459
Australia	2015206797