Details for Patent: 11,771,667

Which drugs does patent 11,771,667 protect, and when does it expire?

Patent 11,771,667 protects SUNOSI and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,771,667

Title:	Methods of administering solriamfetol to lactating women
Abstract:	Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Malta Ltd
Application Number:	US18/176,816
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,771,667
Patent Claim Types: see list of patent claims	Use;

US Patent 11,771,667: Solriamfetol Lactation Claims, Exclusivity, Litigation, and Patent Landscape

US Patent 11,771,667 covers timed administration of solriamfetol to a breastfeeding mother so that the infant receives breast milk at least five hours after dosing. The patent does not claim solriamfetol itself, a tablet formulation, or the treatment of excessive daytime sleepiness generally. Its scope is limited to lactating mothers, specified once-daily doses, delayed breastfeeding, and reduced infant exposure or reduced risk of infant adverse events.

The four independent claims divide into two dose groups and two outcome formulations:

Independent claim	Maternal dose	Breastfeeding interval	Infant-dose limitation	Outcome limitation
Claim 1	About 150 mg once daily	At least about 5 hours	About 0.3 mg or lower	Reduced potential for adverse events
Claim 8	About 75 mg once daily	At least about 5 hours	About 0.15 mg or lower	Reduced potential for adverse events
Claim 15	About 150 mg once daily	At least about 5 hours	About 0.3 mg or lower	Decreased infant exposure
Claim 21	About 75 mg once daily	At least about 5 hours	About 0.15 mg or lower	Decreased infant exposure

The patent is commercially relevant as a narrow method-of-use patent for breastfeeding patients using Sunosi, the branded solriamfetol product marketed by Jazz Pharmaceuticals. Its practical value depends on whether a generic or other solriamfetol manufacturer markets its product for use by lactating patients and whether the manufacturer induces the claimed dosing and breastfeeding schedule.

What does US Patent 11,771,667 cover?

The patent covers a treatment protocol with five required elements:

1. The patient is a lactating human mother.
2. The mother is feeding an infant with breast milk.
3. Solriamfetol is administered orally once daily.
4. The dose is approximately 75 mg or 150 mg.
5. Breast milk is given to the infant at least approximately five hours after maternal administration.

The protocol must also produce or be directed to one of the specified infant-exposure outcomes. Claims 1 through 14 focus on reduced potential for infant adverse events. Claims 15 through 26 focus on decreased infant exposure.

The claims identify agitation, insomnia, anorexia, and reduced weight gain as the relevant infant adverse events. Dependent claims 3, 10, 16, and 22 require that the infant does not experience those events due to solriamfetol transferred through breast milk.

What diseases and patient populations are covered?

The claims identify:

• Excessive daytime sleepiness
• Attention deficit hyperactivity disorder
• Binge eating disorder
• Depression
• Cognitive impairment

The dependent claims further identify excessive daytime sleepiness associated with:

• Narcolepsy
• Obstructive sleep apnea
• Shift work disorder
• Major depression
• Parkinson's disease

The covered maternal populations include mothers:

• One day to 24 months postpartum
• Ten days to 12 months postpartum
• Eighteen to 45 years of age

These limitations are cumulative when read with the applicable independent claim. A patient outside the expressly claimed postpartum or age ranges may still fall within an independent claim if those characteristics are not incorporated into that claim. A patient within a dependent-claim range creates a more specific infringement pathway.

How do the independent claims differ?

Claims 1 and 8 are directed to lowering the potential for adverse events. Claims 15 and 21 are directed to decreasing infant exposure. The dose thresholds are internally linked:

Maternal dose	Claimed maximum daily infant dose
150 mg	About 0.3 mg or lower
75 mg	About 0.15 mg or lower

The claim set therefore treats the infant exposure threshold as approximately proportional to the maternal dose. The five-hour interval is present in all four independent claims and is likely the central operational limitation.

Claims 1 and 15 are materially similar, as are claims 8 and 21. The difference is the result language:

• "Potential for adverse events ... is decreased"
• "Exposure ... is decreased"

That distinction may affect claim construction and proof. A party asserting claims 1 or 8 may need to establish a reduced adverse-event risk. A party asserting claims 15 or 21 may rely on pharmacokinetic evidence showing lower infant exposure, even if no infant adverse event occurs.

What are the key claim-construction issues?

What does "about 75 mg" or "about 150 mg" mean?

The claims use approximate dose language. The scope may include clinically equivalent dose amounts, but the permissible deviation would depend on the specification, prosecution history, and ordinary pharmaceutical dosing practice. A generic label using 75 mg and 150 mg tablets would create a direct factual alignment with the claim language.

What does "at least about 5 hours" require?

The breastfeeding event must occur no earlier than approximately five hours after administration. The claim does not require that all breast milk feeds occur after five hours, nor does it expressly require milk pumping, discarding, or storage. A schedule instructing the mother to avoid feeding for five hours would more closely track the claim than a label that merely reports lactation pharmacokinetics.

Must the infant dose be measured?

The claims recite a daily infant dose of approximately 0.15 mg or 0.3 mg or lower. That limitation may be established through measured milk concentrations, pharmacokinetic modeling, estimated milk intake, or other evidence accepted by the court. The patent does not appear to require a particular measurement method in the claims supplied.

Is actual absence of adverse events required?

Claims 1 and 8 recite a decreased potential for adverse events. Claims 3 and 10 require that the infant does not experience specified adverse events. Claims 15 and 21 use decreased exposure rather than a clinical outcome. This creates different evidentiary burdens across the claim groups.

How strong is the patent estate for solriamfetol lactation use?

The patent is narrow in subject matter but potentially difficult to design around if the branded or generic product instructions specify the same dose and five-hour breastfeeding interval.

Strength factor	Assessment
Dose specificity	Strong. The claims identify the two commercially important doses, 75 mg and 150 mg.
Timing specificity	Strong. All independent claims require breastfeeding at least approximately five hours after dosing.
Patient limitation	Narrow. The claims require a lactating mother feeding an infant with breast milk.
Therapeutic scope	Broad within lactation. Multiple disorders and causes of excessive daytime sleepiness are listed.
Infant exposure limitation	Potentially fact-intensive. Dose and exposure may require pharmacokinetic evidence.
Formulation coverage	None apparent from the supplied claims.
Composition coverage	None. The patent does not claim solriamfetol as a chemical compound.
Manufacturing coverage	None apparent.
Regulatory leverage	Dependent on whether the patent is listed for the relevant NDA and whether the generic label induces the claimed conduct.

The patent is stronger against a product label that expressly recommends use by breastfeeding mothers with a five-hour delay. It is weaker against a generic label that omits lactation instructions and does not encourage the patented protocol, although induced infringement may still turn on promotional materials, prescribing information, medical communications, and the overall intended-use evidence.

What is the FDA status of solriamfetol and breastfeeding?

FDA approved Sunosi for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The approved dosing range is 37.5 mg to 150 mg once daily, with 150 mg as the maximum recommended dose.[2]

The FDA labeling does not establish approval for ADHD, binge eating disorder, depression, cognitive impairment, shift work disorder, or Parkinson's disease. Those uses appear in the patent claims, but they are not equivalent to FDA-approved indications.

The labeling states that human milk data are limited or unavailable and that the effect on the breastfed infant is not established.[2] The patent claims attempt to convert a lactation-management protocol into a specific method of reducing infant exposure.

What is the Orange Book status of US Patent 11,771,667?

Orange Book relevance depends on whether the patent has been submitted to FDA for listing against the applicable solriamfetol NDA and whether FDA accepted a qualifying use code. A method-of-use patent can be listed when it claims an approved method of using the drug, but a patent directed only to unapproved indications may face listing limitations under FDA regulations.

The patent's lactation protocol is not itself an FDA-approved indication for Sunosi. The approved indications are narcolepsy and obstructive sleep apnea. Claims directed to use in those conditions could have a stronger regulatory connection than claims directed to ADHD, binge eating disorder, depression, or cognitive impairment.

The supplied claims do not establish that US 11,771,667 is listed in the Orange Book. Orange Book listing, use-code wording, and any delisting or dispute history must be confirmed from FDA's current Approved Drug Products with Therapeutic Equivalence Evaluations database.[3]

When does solriamfetol lose exclusivity?

US Patent 11,771,667 has a grant date of October 3, 2023. The patent's expiration date cannot be derived from the claims alone. The enforceable term generally runs 20 years from the earliest effective nonprovisional US or international filing date, subject to terminal disclaimers, patent-term adjustment, and patent-term extension under 35 U.S.C. §§ 154 and 156.[1]

The patent should therefore be analyzed separately from:

• Solriamfetol compound patents
• Salt, polymorph, or crystal-form patents
• Tablet or capsule formulation patents
• Manufacturing-process patents
• Earlier method-of-use patents
• Any pediatric exclusivity or regulatory exclusivity attached to the NDA

A generic applicant can challenge each relevant patent through an ANDA Paragraph IV certification if the patent is listed and relevant. If the patent is not listed, the applicant may not face the same statutory certification and 30-month-stay structure for that patent.

What Paragraph IV challenges and litigation affect this patent?

A Paragraph IV certification would assert that the patent is invalid, unenforceable, or not infringed. For this patent, the most likely attack points are:

Anticipation

A challenger would search for prior disclosures of:

• Solriamfetol use during lactation
• A five-hour post-dose breastfeeding delay
• Infant-dose thresholds of 0.15 mg or 0.3 mg
• Reduced infant exposure or adverse-event risk

A reference would need to disclose every claim element, either expressly or inherently.

Obviousness

Obviousness is likely to focus on combining known elements:

• FDA-approved 75 mg and 150 mg solriamfetol dosing
• Known maternal plasma and milk pharmacokinetics
• Known breastfeeding risk-management practices
• A predictable post-dose waiting interval
• Infant exposure calculations

The patentee would argue that the specific five-hour interval and infant-dose thresholds were not predictable or were supported by unexpected pharmacokinetic or clinical results.

Written description and enablement

The claims cover multiple disorders, postpartum periods, ages, and two dose levels. A challenger may test whether the specification supports the full breadth of the claimed patient populations and outcomes, particularly the claim language concerning decreased adverse-event potential.

Indefiniteness

Terms such as "about," "potential for adverse events," and "decreased" may be challenged if the specification does not provide objective boundaries. The five-hour limitation is more concrete, although "about 5 hours" still requires interpretation.

No specific Paragraph IV complaint, ANDA settlement, or infringement judgment is established by the supplied claim text. Public litigation databases and FDA records should be reviewed for any later-filed action or listing dispute.

Which companies are most exposed?

Jazz Pharmaceuticals is the principal commercial party associated with Sunosi. A generic applicant would face greater risk if its labeling or communications:

• Identify breastfeeding as an intended population;
• Recommend 75 mg or 150 mg once-daily dosing for lactating mothers;
• Recommend breastfeeding after a five-hour waiting period;
• State that infant exposure or adverse events are reduced; or
• Provide instructions that necessarily result in the claimed protocol.

A generic label that simply omits lactation information may reduce induced-infringement risk but could create prescribing or regulatory tensions if clinicians ask for breastfeeding guidance. The claim does not cover every sale of solriamfetol and does not block generic use for nonlactating patients.

What licensing and settlement issues matter?

The relevant commercial questions are:

1. Whether Jazz owns or exclusively controls the patent rights.
2. Whether the patent is included in any generic settlement covering Sunosi.
3. Whether a settlement permits an authorized generic, a date-certain launch, or a carve-out for non-lactation indications.
4. Whether the parties exchange covenants concerning lactation labeling or medical-information communications.
5. Whether a license covers only US rights or extends to Canada, Europe, Japan, and other jurisdictions.

The claims are US claims. They have no direct legal effect outside the United States. Foreign family members may differ materially in scope, prosecution outcome, and expiration.

What generic launch scenarios exist?

Scenario	Risk profile
Generic label includes lactation dosing and five-hour breastfeeding delay	High infringement and inducement risk
Generic label includes general lactation warnings but no claimed timing protocol	Intermediate risk
Generic label omits lactation use and does not promote the protocol	Lower induced-infringement risk, subject to facts
Generic product launches for nonlactating patients only	Patent claims generally have limited relevance
Generic challenges listed patent through Paragraph IV	Litigation and possible 30-month stay depend on Orange Book status
Generic uses a different dose or breastfeeding interval	Potential design-around, subject to claim construction

Key Takeaways

• US Patent 11,771,667 claims a lactation-specific solriamfetol dosing and breastfeeding schedule.
• The four independent claims cover 75 mg or 150 mg once-daily maternal dosing.
• Breast milk must be fed at least approximately five hours after administration.
• The claimed infant-dose ceilings are approximately 0.15 mg for the 75 mg regimen and 0.3 mg for the 150 mg regimen.
• The patent covers reduced infant exposure and reduced risk of infant adverse events, not solriamfetol composition, formulation, or manufacturing.
• FDA approval of Sunosi currently covers excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, not all indications recited in the patent.
• Orange Book listing and use-code status are decisive for Paragraph IV exposure but are not established by the claim language.
• The principal validity issues are obviousness, enablement, written description, and the meaning of "about," "decreased," and "potential for adverse events."
• Generic risk is highest when labeling or promotional materials instruct lactating mothers to use 75 mg or 150 mg and delay breastfeeding for approximately five hours.

FAQs

Does US Patent 11,771,667 block all generic solriamfetol sales?

No. The claims are limited to treating a lactating mother under a specified dosing and breastfeeding protocol. They do not cover nonlactating patients or all uses of solriamfetol.

Can a generic manufacturer avoid the patent by removing lactation instructions?

Possibly, but label omission alone does not resolve all infringement issues. Promotional activity, medical-information materials, physician communications, and the product's intended use may affect induced-infringement analysis.

Does the patent cover a 37.5 mg solriamfetol dose?

The supplied independent claims specify approximately 75 mg or 150 mg once daily. A 37.5 mg regimen is outside those express dose limitations, subject to claim construction of "about."

Are the ADHD and binge eating disorder claims FDA-approved uses?

No. Their inclusion in the patent does not establish FDA approval. The FDA-approved Sunosi indications are excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Does the patent cover pumping and storing breast milk?

The claims supplied require feeding the infant breast milk obtained from the mother at least approximately five hours after administration. They do not expressly require or exclude pumping, discarding, freezing, or storing milk.

References

1. United States Patent and Trademark Office. (2023). US Patent No. 11,771,667 B2.
2. U.S. Food and Drug Administration. (2023). Sunosi (solriamfetol) prescribing information. Jazz Pharmaceuticals, Inc.
3. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations.
4. 35 U.S.C. §§ 154, 156, 271, 281, 282.
5. 21 C.F.R. § 314.53.

Drugs Protected by US Patent 11,771,667

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019	AB	RX	Yes	No						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019	AB	RX	Yes	Yes						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL

International Family Members for US Patent 11,771,667

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2023415568
Australia	2024308064
China	120641090
China	121620365
European Patent Office	4642446