Details for Patent: 9,730,910

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Which drugs does patent 9,730,910 protect, and when does it expire?

Patent 9,730,910 protects HETLIOZ and HETLIOZ LQ and is included in two NDAs.

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

Summary for Patent: 9,730,910

Title:	Treatment of circadian rhythm disorders
Abstract:	Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.
Inventor(s):	Marlene Michelle Dressman, John Joseph Feeney, Louis William Licamele, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US14/510,321
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,730,910
Patent Claim Types: see list of patent claims	Use;

United States Patent 9,730,910: Scope, Claims, Expiration and Tasimelteon Patent Landscape

U.S. Patent No. 9,730,910 protects a narrow treatment sequence for patients receiving rifampicin who are subsequently treated with tasimelteon. The patent does not broadly cover tasimelteon, all CYP3A4 interactions, or every treatment of Non-24-Hour Sleep-Wake Disorder. Its central limitation is the discontinuation of rifampicin before tasimelteon treatment to avoid rifampicin-induced reduction of tasimelteon exposure.

The patent was issued to Vanda Pharmaceuticals Inc. on August 15, 2017. Its nominal expiration date is March 14, 2034, subject to any applicable patent-term adjustment reflected in the official patent and Orange Book records.[1][2]

What does U.S. Patent 9,730,910 protect?

U.S. Patent 9,730,910, titled “Methods of Treating Circadian Rhythm Disorders,” protects a method involving:

1. A patient receiving rifampicin.
2. Discontinuation of rifampicin.
3. Subsequent treatment with tasimelteon.
4. Avoidance of concurrent rifampicin and tasimelteon use.
5. Avoidance of reduced tasimelteon exposure caused by CYP3A4 induction.

The patent is directed to a drug-interaction management strategy rather than to the tasimelteon molecule itself.

Patent characteristic	Details
U.S. patent	9,730,910 B2
Title	Methods of treating circadian rhythm disorders
Patent holder	Vanda Pharmaceuticals Inc.
Issue date	August 15, 2017
Priority basis	U.S. and international filings dating to March 2013
Nominal expiration	March 14, 2034
Drug	Tasimelteon
Commercial product	Hetlioz
Therapeutic area	Circadian rhythm disorders
Key interaction	Rifampicin induction of CYP3A4
Claim category	Method of treatment
Likely regulatory relevance	Orange Book-listed method-of-use patent for Hetlioz

How do the claims of Patent 9,730,910 differ?

The five claims form a descending hierarchy. Claim 1 contains the principal commercial and infringement risk. Claims 2 through 5 narrow the patient population, indication, dose, and therapeutic outcome.

Claim 1: Rifampicin discontinuation before tasimelteon

Claim 1 requires treatment of a patient for a circadian rhythm disorder where the patient is receiving rifampicin. The method then requires:

• discontinuing rifampicin; and
• treating the patient with tasimelteon after that discontinuation.

The claim also recites the purpose or result of avoiding:

• use of tasimelteon in combination with rifampicin; and
• reduced tasimelteon exposure from CYP3A4 induction.

The claim does not specify a minimum rifampicin washout period. It also does not require a particular tasimelteon dose, route, sleep schedule, or circadian disorder.

The broadest practical reading of claim 1 covers a physician-directed treatment sequence in which rifampicin is stopped before tasimelteon is prescribed or administered. The sequence requirement matters. A patient who receives tasimelteon while continuing rifampicin would not practice the claimed method as written.

Claim 2: Non-24-Hour Sleep-Wake Disorder

Claim 2 limits claim 1 to treatment of Non-24-Hour Sleep-Wake Disorder, commonly called Non-24.

This limitation narrows the claim from any circadian rhythm disorder to a specific disorder recognized in the Hetlioz labeling and FDA approval materials.[3]

Claim 3: Light-perception-impaired patients

Claim 3 further limits the patient to an individual with impaired light perception, often described as totally blind or blind with no light perception.

The claim does not appear to require complete blindness. The term “light perception impaired” can cover patients whose ability to receive or process environmental light cues is insufficient to maintain a normal 24-hour circadian cycle.

Claim 4: 20 mg once daily before target bedtime

Claim 4 requires:

• oral administration;
• 20 mg of tasimelteon;
• once-daily dosing; and
• administration before a target bedtime.

This limitation tracks the approved adult Hetlioz dosing regimen for Non-24. The FDA label recommends 20 mg once daily before bedtime, at approximately the same time each night.[3]

Claim 5: Entrainment to a 24-hour cycle

Claim 5 adds a treatment result. The patient must become entrained to a 24-hour sleep-wake cycle, awaken at or near a target wake time, and sleep approximately seven to nine hours daily.

This is the narrowest claim. It combines the rifampicin discontinuation sequence with the Non-24 indication, light-perception impairment, approved dose and route, and a defined sleep-wake outcome.

What is the technical rationale for the patent?

Rifampicin is a strong inducer of CYP3A4. Tasimelteon is metabolized in part through CYP3A4. Rifampicin therefore can materially reduce tasimelteon plasma exposure and weaken its pharmacologic effect.

The FDA prescribing information identifies strong CYP3A4 inducers, including rifampin, as drugs that should not be used with Hetlioz because of the risk of reduced tasimelteon exposure.[3] The patent converts that interaction into a treatment protocol: stop rifampicin first, then administer tasimelteon.

The claimed mechanism is clinically straightforward:

Treatment condition	Expected consequence
Rifampicin continued with tasimelteon	CYP3A4 induction and reduced tasimelteon exposure
Rifampicin discontinued before tasimelteon	Avoidance of the interaction
Tasimelteon administered after discontinuation	Potentially restored exposure relative to coadministration
Continued daily tasimelteon in Non-24	Potential entrainment of the sleep-wake cycle

The patent does not claim a new chemical entity. Its value depends on the clinical workflow, prescribing instructions, and the extent to which a generic label or physician practice directs the claimed sequence.

How strong is the patent scope of U.S. Patent 9,730,910?

The patent has meaningful but narrow scope.

Strengths

The principal strengths are:

• Claim 1 reaches treatment of any circadian rhythm disorder, not only Non-24.
• The claim addresses a clinically relevant and label-recognized contraindication or avoidance instruction.
• The claimed sequence can be practiced through ordinary physician prescribing decisions.
• Dependent claims track the FDA-approved Hetlioz regimen and the core commercial patient population.
• The patent term extends well beyond the seven-year orphan-drug exclusivity period for Hetlioz.

Limitations

The principal limitations are:

• The claims require rifampicin exposure before tasimelteon treatment.
• The claims require discontinuation of rifampicin.
• They do not cover patients who never used rifampicin.
• They do not cover tasimelteon treatment generally.
• They do not prevent a generic entrant from marketing tasimelteon for uses outside the claimed rifampicin sequence if those uses are not covered by other patents.
• Claim 5 requires a clinical entrainment result that may create proof issues in litigation.

The patent is therefore more important as an Orange Book method-of-use barrier than as a complete exclusionary right over all tasimelteon prescriptions.

What is the Orange Book status of Patent 9,730,910?

Patent 9,730,910 is associated with Hetlioz, Vanda’s tasimelteon product. FDA Orange Book listings for drug products can include patents covering active ingredients, formulations, methods of use, or other approved product features.[2]

The patent’s likely Orange Book significance is its method-of-use coverage for the interaction between tasimelteon and strong CYP3A4 inducers, particularly rifampicin. An Orange Book listing can require an ANDA applicant to address the patent through one of four certifications:

• Paragraph I: no patent information is listed;
• Paragraph II: the listed patent has expired;
• Paragraph III: the applicant will wait until patent expiration;
• Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.

A Paragraph IV certification triggers potential Hatch-Waxman litigation if the patent holder sues within the statutory period. The patent listing does not itself prevent approval of every generic tasimelteon product. Its effect depends on the applicant’s proposed labeling and the scope of the listed use code.[4]

When does tasimelteon lose exclusivity?

Tasimelteon has multiple layers of protection.

Protection	Relevant date or status
FDA approval of Hetlioz	June 3, 2014
Orphan-drug exclusivity	Approximately seven years from approval, ending in 2021
U.S. Patent 9,730,910	Nominal expiration March 14, 2034
Generic pathway	ANDA, subject to patent certifications
Biosimilar pathway	Not applicable

Orphan-drug exclusivity expired before the nominal expiration of Patent 9,730,910. The patent is therefore the more important remaining barrier for the specific claimed method.

The presence of an unexpired method-of-use patent does not necessarily prevent approval of a generic product for every indication. An ANDA applicant may seek approval with a patented indication carved out, provided the resulting labeling and distribution do not unlawfully encourage infringement.

Which companies are challenging the Hetlioz patent estate?

Generic competition to tasimelteon would most likely arise through an ANDA rather than a biosimilar application. Tasimelteon is a chemically synthesized small molecule, so the Biologics Price Competition and Innovation Act pathway does not apply.

Publicly reported litigation and regulatory activity involving Vanda’s Hetlioz franchise has focused on ANDA challenges by generic manufacturers, including Teva Pharmaceuticals. The relevant risk analysis must distinguish between:

1. challenges to broad Non-24 treatment patents;
2. challenges to interaction and method-of-use patents such as U.S. 9,730,910;
3. formulation or dosage patents; and
4. patent claims that can be avoided through a skinny label.

A generic applicant can challenge a listed patent by filing a Paragraph IV certification. Vanda may then assert the patent in federal court. Litigation exposure depends on the specific ANDA labeling, proposed indication, use code, and prescribing instructions.

What generic launch risks exist under Patent 9,730,910?

A generic launch can occur through several pathways.

Full-label launch

A full-label ANDA that includes treatment of Non-24 in light-perception-impaired patients, with warnings or instructions concerning rifampicin, could create substantial infringement risk. The risk is highest if the label instructs physicians to discontinue rifampicin and then initiate tasimelteon.

Skinny-label launch

A generic applicant may omit the patented rifampicin-related use if FDA regulations permit the omission and the remaining label supports a noninfringing use.

The risk is lower if the generic label:

• excludes the rifampicin discontinuation sequence;
• omits the patented treatment instruction;
• does not direct use in the claimed patient population; and
• avoids promotional conduct encouraging the patented use.

The risk is not eliminated if the remaining label, prescribing information, or commercial conduct still actively encourages the claimed method.

Physician-directed infringement

Method claims are often practiced by physicians and patients rather than by the manufacturer directly. Vanda would therefore need to establish direct infringement by a patient or healthcare provider and potential induced infringement by the generic manufacturer.

A generic company’s knowledge of the patent, standing alone, is not enough. The evidence would generally focus on label language, promotional materials, dosage instructions, and the relationship between the approved indication and the patented method.

What other patents cover tasimelteon and Hetlioz?

Patent 9,730,910 should be analyzed as one part of a broader Vanda estate. The commercial risk may come from overlapping patents covering:

• treatment of Non-24;
• treatment in totally blind or light-perception-impaired patients;
• 20 mg daily dosing;
• timing of administration before bedtime;
• entrainment to a 24-hour cycle;
• pharmaceutical compositions;
• solid dosage forms;
• manufacturing processes;
• metabolite or impurity control;
• pediatric or other circadian rhythm indications.

Vanda’s earlier U.S. Patent 8,697,697 is commonly associated with methods of treating circadian rhythm disorders and the clinical use of tasimelteon. Later patents may extend protection for particular patient groups, dosing regimens, or product attributes.[5]

Patent category	Relevance to generic risk
Broad Non-24 method patents	May block the principal approved use
Rifampicin-interaction patent	Targets a narrower drug-interaction sequence
Formulation patents	Can affect product composition and manufacturing
Dose and timing patents	May cover commercial prescribing instructions
Manufacturing patents	May create supplier or process constraints
Use-specific patents	May be avoidable through labeling carve-outs

The strongest practical estate is usually the combination of broad indication patents and narrower Orange Book-listed method patents. Patent 9,730,910 alone does not create a complete monopoly over tasimelteon.

Are biosimilar risks relevant to tasimelteon?

No. Tasimelteon is a small-molecule drug, not a biologic. Competitors would use the ANDA pathway, not the abbreviated biologics license application pathway.

The principal competitive risks are:

• Paragraph IV ANDA litigation;
• skinny-label approval;
• authorized generic competition;
• compound sourcing and manufacturing challenges;
• physician substitution behavior;
• payer pressure after regulatory exclusivity ends.

What manufacturing and intellectual-property barriers remain?

Patent 9,730,910 is not a manufacturing patent. It does not claim the synthesis of tasimelteon, a particular crystal form, a formulation excipient system, or a manufacturing process.

Manufacturing barriers may still arise from other patents, regulatory requirements, and commercial know-how. A generic applicant would need to establish pharmaceutical equivalence, bioequivalence, stability, impurity controls, and commercial-scale manufacturing capability.

The patent’s main barrier is behavioral rather than technical. It affects how tasimelteon is prescribed when a patient is receiving rifampicin.

What licensing deals affect the patent landscape?

Vanda obtained rights to develop tasimelteon after the compound was originally associated with Bristol-Myers Squibb. Public disclosures have described collaboration and licensing arrangements relating to tasimelteon development and commercialization.[6]

No separate publicly identified license appears to transfer or independently commercialize the specific rifampicin-discontinuation claims of U.S. 9,730,910. The patent remains part of Vanda’s broader Hetlioz intellectual-property position.

What is the commercial exposure from Patent 9,730,910?

The patent does not protect all Hetlioz revenue. Its exposure is limited to patients who:

1. have a circadian rhythm disorder;
2. are receiving rifampicin;
3. discontinue rifampicin; and
4. then receive tasimelteon.

Claims 2 through 5 narrow the exposure further to Non-24 patients with impaired light perception who receive the approved 20 mg regimen and achieve entrainment.

The broader commercial value comes from portfolio leverage. Vanda can use the patent in combination with broader method-of-use patents to delay or complicate generic entry, even though the '910 patent alone may be avoidable through a carefully drafted ANDA label.

Key Takeaways

• U.S. Patent 9,730,910 protects a treatment sequence, not the tasimelteon molecule.
• The central requirement is discontinuation of rifampicin before tasimelteon treatment.
• Rifampicin is relevant because it induces CYP3A4 and can reduce tasimelteon exposure.
• Claim 1 is the broadest claim; claims 2 through 5 narrow the indication, patient population, dose, route, and clinical outcome.
• The nominal patent expiration is March 14, 2034.
• The patent has greater value as an Orange Book method-of-use barrier than as a complete block on generic tasimelteon.
• A skinny-label strategy may reduce infringement risk, but label language and promotional conduct remain critical.
• Tasimelteon faces generic, not biosimilar, competition.
• The patent should be assessed with Vanda’s broader Non-24, dosing, formulation, and manufacturing patent families.

FAQs

Can a generic company sell tasimelteon while Patent 9,730,910 remains unexpired?

Potentially. A generic applicant may seek approval with a Paragraph IV certification or omit the patented use through a skinny label. The outcome depends on the approved label and infringement analysis.

Does Patent 9,730,910 cover patients who never used rifampicin?

No. The claims require that the patient is being treated with rifampicin before rifampicin is discontinued.

Does the patent require a specific rifampicin washout period?

The claims provided do not specify a fixed washout period. They require discontinuation followed by tasimelteon treatment.

Does the patent cover all 20 mg tasimelteon prescriptions?

No. The 20 mg limitation appears in claim 4, but the claim also requires the rifampicin sequence and the narrower patient and indication limitations inherited from claims 1 through 3.

Is Patent 9,730,910 a composition-of-matter patent?

No. It is a method-of-treatment patent directed to managing the interaction between rifampicin and tasimelteon.

References

1. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,730,910, Methods of treating circadian rhythm disorders.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2020). Hetlioz (tasimelteon) prescribing information. Vanda Pharmaceuticals Inc.
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application: ANDA approval and patent certification requirements.
5. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,697,697, Methods of treating circadian rhythm disorders.
6. Vanda Pharmaceuticals Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission.

Drugs Protected by US Patent 9,730,910

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	9,730,910					TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH RIFAMPIN
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	9,730,910					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	9,730,910					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN

International Family Members for US Patent 9,730,910

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013211878
Australia	2013211880
Australia	2013361459
Australia	2015206797
Australia	2016204178