Details for Patent: 11,173,134

Which drugs does patent 11,173,134 protect, and when does it expire?

Patent 11,173,134 protects SPRAVATO and is included in one NDA.

This patent has twelve patent family members in ten countries.

Summary for Patent: 11,173,134

Title:	Methods for the treatment of depression
Abstract:	The present invention is directed to methods and dosing regimens for the treatment of depression (preferably, treatment resistant depression), for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. suicidal ideations).
Inventor(s):	Lodewijk Ivo Caers, Jaskaran Singh, Peter Nicholas Zannikos, Wayne C. Drevets, Ella Daly, Carla Marie Canuso, Margaret Fedgchin, Frank Wiegand
Assignee:	Janssen Pharmaceutica NV
Application Number:	US17/129,508
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,173,134
Patent Claim Types: see list of patent claims	Use; Formulation;

US Patent 11,173,134: Esketamine Maintenance-Treatment Claims, Exclusivity and Patent Landscape

US Patent 11,173,134 protects a regimen for maintaining antidepressant response with intranasal esketamine, the S-enantiomer of ketamine. Its core requirements are an aqueous intranasal formulation, an esketamine-equivalent dose of about 56 mg or 84 mg, and administration once weekly or once every two weeks during a maintenance phase. The patent is assigned to Janssen Pharmaceuticals, Inc. and is directed to method-of-treatment claims rather than a new esketamine molecule, nasal device, or basic formulation.

The commercial relevance is high because the claimed regimen tracks the FDA-approved dosing framework for Spravato, including four-week induction, twice-weekly administration during induction, and weekly or every-other-week maintenance. The patent therefore creates a potential method-of-use barrier for a generic or 505(b)(2) product that seeks approval with the same maintenance schedule.

What does US Patent 11,173,134 protect?

The patent protects treatment methods using intranasal esketamine during maintenance therapy for major depressive disorder, treatment-resistant depression, and major depressive disorder with suicidal ideation or behavior.

The principal claim limitations are:

Limitation	Scope
Patient	Human patient with major depressive disorder, treatment-resistant depression, or MDD with suicidal ideation or behavior
Active ingredient	(S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone, commonly called esketamine
Salt coverage	Esketamine and pharmaceutically acceptable salts, including esketamine hydrochloride
Dosage form	Aqueous intranasal formulation
Dose	About 56 mg or about 84 mg of esketamine
Treatment stage	Maintenance phase
Frequency	Once weekly or once every two weeks
Induction	Optional in claim 1 and claim 21, but expressly defined in dependent claims as approximately four weeks at twice-weekly dosing
Adjunctive therapy	One or more antidepressants, including an oral antidepressant
Duration	At least six, eight, twelve, or fourteen weeks in dependent claims, or until a clinician determines further treatment is not required

The broadest independent claims are claims 1, 21 and 27:

• Claim 1 covers maintenance treatment of MDD.
• Claim 21 covers maintenance treatment of treatment-resistant depression.
• Claim 27 covers maintenance treatment of MDD with suicidal ideation or behavior.

Claims 1 and 21 make prior induction optional. A patient does not necessarily have to satisfy the four-week induction limitation to fall within those claims. Claims 2 through 5 add the twice-weekly induction regimen and esketamine hydrochloride formulation.

How does claim 1 define the protected maintenance regimen?

Claim 1 requires five central elements:

1. Treatment of a human patient with major depressive disorder.
2. Treatment during a maintenance phase.
3. Intranasal administration of an aqueous esketamine formulation.
4. Delivery of about 56 mg or about 84 mg of esketamine.
5. Administration once weekly or once every two weeks.

The claim does not require:

• A specific nasal applicator;
• A specific excipient;
• A defined spray volume;
• A particular plasma concentration;
• A named oral antidepressant;
• A particular depression-rating scale;
• A fixed maximum maintenance duration;
• Prior failure of a specific number of antidepressants; or
• Completion of a four-week induction phase.

The phrase “optionally” is important. In claim 1, the patient may already have received esketamine during an induction phase, but that condition is not required by the independent claim. A generic manufacturer could therefore face infringement risk even where its proposed label does not expressly require the same induction sequence, if the label recommends the claimed maintenance dosing.

What do the dependent claims add?

The dependent claims narrow the regimen by adding clinical setting, induction, duration, formulation, or adjunctive therapy.

Induction-phase limitations

Claim 2 requires:

• A four-week induction phase;
• Intranasal esketamine;
• A 56 mg or 84 mg induction dose; and
• Twice-weekly administration.

This mirrors the principal Spravato induction schedule. Claims 3 through 5 add continuation until the clinician determines treatment is no longer required and specify esketamine hydrochloride.

Duration limitations

Claims 7 through 10 cover maintenance periods of at least:

• Six weeks;
• Eight weeks;
• Twelve weeks; or
• Fourteen weeks.

These claims may be useful against a label that expressly recommends treatment over one of those periods. Their practical value is narrower than claim 1 because the accused treatment must satisfy the minimum-duration limitation.

Adjunctive antidepressant treatment

Claim 11 adds adjunctive treatment with one or more antidepressants. Claims 14, 25 and 29 specify oral antidepressants. This limitation corresponds to the FDA-approved treatment paradigm for treatment-resistant depression, in which Spravato is used with an oral antidepressant.

Disease-specific claims

Claim 12 covers treatment-resistant depression or MDD with suicidal ideation or behavior. Claims 15 through 20 separately develop those indications. Claims 21 through 26 focus on treatment-resistant depression, while claims 27 through 30 focus on MDD with suicidal ideation or behavior.

The claim set therefore uses overlapping disease categories to preserve coverage if a court narrows the construction of “major depressive disorder” or distinguishes treatment-resistant depression from MDD with suicidal ideation or behavior.

What formulations are protected by US Patent 11,173,134?

The patent protects the use of an aqueous formulation containing esketamine or a pharmaceutically acceptable salt. Several claims expressly identify esketamine hydrochloride.

The formulation limitations are functional rather than compositional. The claims do not require a particular:

• Buffer system;
• Preservative;
• Tonicity agent;
• pH range;
• Spray volume;
• Container closure system; or
• Nasal delivery device.

That structure gives the patent broader formulation coverage than a claim limited to a specified excipient combination. An alternative formulation may avoid infringement if it is not aqueous, does not contain esketamine or an embraced salt, or is not administered intranasally. Changing excipients alone may not avoid the claims.

The patent does not appear, from the claims supplied, to cover:

• Intravenous ketamine;
• Oral esketamine;
• Sublingual esketamine;
• Racemic ketamine without the claimed intranasal esketamine regimen;
• A device standing alone; or
• Manufacturing methods for esketamine hydrochloride.

Those activities may be addressed by separate patents.

When does US Patent 11,173,134 expire?

The patent issued on November 16, 2021. Its nominal patent term is tied to the earliest effective nonprovisional priority date in its family. Public patent records identify a 2014 priority basis for the maintenance-treatment subject matter, producing a nominal expiration date in 2035 before any patent-term adjustment. The operative expiration date should be taken from the USPTO patent-term calculation and any applicable terminal disclaimer, not from the issue date alone (U.S. Patent No. 11,173,134, 2021).

Patent-term adjustment can extend the term beyond the basic 20-year period. Patent-term extension under 35 U.S.C. § 156 is a separate issue and generally depends on regulatory review of the patented product and statutory eligibility. The existence of FDA approval does not automatically establish that this particular method patent receives a patent-term extension.

What is the Orange Book status of US Patent 11,173,134?

US Patent 11,173,134 is relevant to the Orange Book landscape for Spravato, NDA 211243, because its claims cover the FDA-approved maintenance use of intranasal esketamine. Orange Book listing, however, is product-specific. A patent is not listed merely because it relates technically to an approved drug.

The Orange Book identifies patents submitted by an NDA holder as covering the drug substance, drug product, or method of use. Method-of-use patents are generally associated with FDA-approved uses and can generate a corresponding use-code entry. A generic applicant must address listed patents through a Paragraph III certification, Paragraph IV certification, or a section viii statement where the patented use is carved out from the proposed labeling (FDA, 2024).

For this patent, the relevant commercial question is whether a proposed generic label includes:

• Maintenance dosing;
• Weekly or every-other-week administration;
• Treatment-resistant depression;
• MDD with suicidal ideation or behavior;
• Use after esketamine induction; or
• Adjunctive use with an oral antidepressant.

A label that omits the patented maintenance use may reduce method-of-use exposure, but the analysis depends on the precise Orange Book use code and the final proposed labeling.

What Paragraph IV challenges could affect the patent?

A Paragraph IV applicant would assert that a listed patent is invalid, unenforceable, or not infringed. For US Patent 11,173,134, likely challenge theories include:

Challenge theory	Potential argument
Written description	The specification may not adequately support the full breadth of every disease category, dose, frequency, duration and adjunctive-treatment combination
Enablement	The applicant could argue that the full genus of maintenance regimens is not enabled without undue experimentation
Obviousness	Weekly or every-other-week maintenance may be argued to have been predictable from induction studies, known ketamine pharmacology and continuation-treatment practice
Anticipation	Earlier clinical or patent disclosures could be examined for the same esketamine dose and maintenance schedule
Claim construction	“About 56 mg,” “about 84 mg,” “maintenance phase,” and “therapeutically effective amount” may be disputed
Indefiniteness	“Until further treatment is not required as determined by a clinician or physician” may be challenged as a subjective endpoint
Noninfringement	A proposed product may omit the patented indication, schedule, adjunctive therapy or maintenance language

The strongest infringement risk generally arises when the generic label reproduces the approved Spravato regimen. A skinny-label strategy could remove one or more patented indications or maintenance instructions. That strategy does not automatically eliminate risk if the remaining label, promotional conduct, or product design encourages the patented use.

Which companies are challenging Spravato patent protection?

The principal commercial challenger class is generic and 505(b)(2) developers seeking an intranasal esketamine product. A definitive assessment of named Paragraph IV filers and current litigation requires the contemporaneous FDA ANDA database, Orange Book certifications, PACER records and district-court dockets. The supplied patent and claim text do not establish a current defendant, filed Paragraph IV notice, settlement, or final judgment.

No conclusion about a specific company’s challenge, settlement or launch date follows from the patent claims alone. For business planning, the relevant diligence point is whether an applicant has filed a Paragraph IV certification against this patent and whether Janssen has triggered the 30-month stay under the Hatch-Waxman framework.

What FDA exclusivity protects Spravato apart from patents?

Spravato received FDA approval in March 2019 for treatment-resistant depression in adults as an adjunct to an oral antidepressant. FDA later approved its use for depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior, also with an oral antidepressant. The product is administered under a Risk Evaluation and Mitigation Strategy because of sedation, dissociation, abuse and misuse risks (FDA, 2019; FDA, 2020).

Regulatory exclusivity is separate from patent protection. New-drug exclusivity for the original approval has expired. The later indication may have generated additional regulatory protection depending on the approval basis and statutory exclusivity determination, but that protection does not necessarily prevent approval of every generic version. A generic applicant may be able to rely on an abbreviated pathway while carving out protected indications.

The REMS requirement creates a separate market-entry barrier. An applicant must address controlled-substance handling, certified healthcare settings, post-administration monitoring and patient transportation restrictions. FDA has modified REMS requirements over time, but the safety controls remain relevant to development, labeling and commercialization.

How strong is the patent estate for esketamine maintenance treatment?

US Patent 11,173,134 is strong against a product that follows the commercial Spravato regimen because its central limitations are clinically standard and label-visible:

• 56 mg or 84 mg dose;
• Intranasal aqueous formulation;
• Weekly or every-other-week maintenance;
• Treatment-resistant depression or MDD;
• Optional induction; and
• Optional oral-antidepressant combination.

Its principal vulnerability is that it is a regimen patent based on known active pharmaceutical technology. The drug, salt, nasal formulation, device, manufacturing process and separate indications may be covered by other family members, but this patent does not independently establish exclusivity over all esketamine products.

The most meaningful design-around options are:

1. Excluding maintenance dosing from the label;
2. Omitting the patented indication;
3. Using a nonintranasal route;
4. Using a dosing schedule outside weekly or every-other-week administration;
5. Developing a different active ingredient or formulation; or
6. Relying on a section viii carve-out for the patented use.

The commercial value of those strategies depends on whether the noninfringing label remains medically and economically viable.

How does the patent compare with formulation and compound patents?

Patent category	What it protects	Relevance to a generic
Compound patent	Esketamine or related chemical entity	May block the active ingredient itself until expiration
Salt or solid-state patent	Esketamine hydrochloride, polymorphs or crystalline forms	Can restrict API sourcing and manufacture
Formulation patent	Aqueous nasal formulation, excipients or stability characteristics	Can block an equivalent nasal product
Device patent	Nasal spray container, metering or actuation system	May require a different device
Method-of-use patent	Dose, indication, frequency and maintenance sequence	Can be addressed through label carving or Paragraph IV litigation
Manufacturing patent	Synthesis, resolution, purification or packaging	Can constrain API supply or require process redesign

US Patent 11,173,134 is principally in the method-of-use category. It should not be treated as a complete substitute for a family-level freedom-to-operate review.

What litigation and settlement issues matter?

A litigation assessment should focus on four questions:

1. Whether Janssen has sued a Paragraph IV filer within 45 days of receiving notice.
2. Whether the court has imposed a 30-month stay on FDA approval.
3. Whether the parties have entered a launch settlement, including a licensed entry date.
4. Whether the case has produced a claim-construction, invalidity or noninfringement decision.

Potential settlement terms could include a licensed launch date, an authorized generic arrangement, restrictions on formulation or indication, or a covenant tied to particular claims. A settlement involving one listed patent would not necessarily resolve other Spravato patents.

Because the claims cover label-visible maintenance treatment, a successful Paragraph IV challenge could materially accelerate entry. Conversely, an enforceable patent could delay a full-label generic until the patent expires or a settlement license takes effect.

What revenue exposure is associated with this patent?

Spravato is a commercially significant product for Johnson & Johnson, with sales exceeding $1 billion annually in recent reporting periods. The maintenance indication is central to product persistence because patients who respond during induction may continue weekly or every-other-week dosing. A generic that can sell only for a nonprotected indication would have a smaller addressable market than a full-label competitor.

Revenue exposure depends on:

• The timing of generic entry;
• Whether entry is full-label or skinny-label;
• The number of successful entrants;
• REMS and controlled-substance infrastructure;
• Payer coverage;
• Physician willingness to use an alternative nasal product; and
• The survival of formulation, device and manufacturing patents separate from US 11,173,134.

The patent is therefore commercially important, but the product’s total exclusivity position depends on the entire Orange Book and non-Orange-Book patent estate.

Key Takeaways

• US Patent 11,173,134 is a method-of-treatment patent covering intranasal esketamine maintenance therapy.
• The core regimen is 56 mg or 84 mg once weekly or once every two weeks.
• Claims cover MDD broadly and separately address treatment-resistant depression and MDD with suicidal ideation or behavior.
• Prior four-week induction is optional in the principal claims but required by certain dependent claims.
• The patent covers aqueous esketamine formulations, including esketamine hydrochloride.
• Adjunctive oral-antidepressant treatment is covered by dependent claims.
• The patent does not independently claim the esketamine molecule, a nasal device, or a manufacturing process.
• A generic reproducing the Spravato maintenance label would face substantial method-of-use exposure.
• A skinny-label, section viii, alternative-route or alternative-frequency strategy could reduce infringement risk.
• The nominal term reaches into 2035, subject to the official USPTO term calculation and any applicable adjustment.
• Full market-entry analysis requires review of the complete Spravato patent family, current Orange Book listings, FDA certifications and litigation records.

FAQs

Does US Patent 11,173,134 cover intravenous ketamine?

No. The supplied claims require intranasal administration of an aqueous formulation containing esketamine or a pharmaceutically acceptable salt. Intravenous racemic ketamine is outside those express limitations.

Does the patent require use with an oral antidepressant?

No. Oral-antidepressant treatment appears in dependent claims. The broad independent claims do not require adjunctive oral antidepressant therapy.

Can a generic avoid the patent by using a 56 mg dose less frequently than every two weeks?

Potentially, because the independent claims require administration once weekly or once every two weeks. A materially different schedule would require separate infringement analysis and could raise regulatory and clinical-development issues.

Does a four-week induction phase have to precede maintenance treatment?

Not under the broadest versions of claims 1, 21 and 27. The induction requirement is optional in those claims. Claims 2 and related dependents impose a four-week, twice-weekly induction limitation.

Does the patent block all esketamine nasal sprays?

No. It targets a specified maintenance-treatment regimen. Other esketamine nasal products may avoid the claims through a different indication, dosing schedule, formulation, route, or label, although separate patents may create additional barriers.

References

Food and Drug Administration. (2019). FDA approves new nasal spray medication for treatment-resistant depression; available only at certified health care settings. U.S. Department of Health and Human Services.

Food and Drug Administration. (2020). FDA approves esketamine nasal spray for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. U.S. Department of Health and Human Services.

Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

U.S. Patent No. 11,173,134. (2021). Methods of treating depression with (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 11,173,134

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes						TREATMENT OF TREATMENT RESISTANT DEPRESSION BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR 1X EVERY TWO WEEKS TO ADULTS WHO HAVE BEEN ADMINISTERED ESKETAMINE IN A INDUCTION PHASE FOR ABOUT 4 WEEKS
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes						TREATMENT OF DEPRESSION IN ADULTS WITH MOD AND ACUTE SUICIDAL IDEATION OR BEHAVIOR IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR LX EVERY 2 WEEKS AFTER INDUCTION PHASE
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes						TREATMENT OF TRD IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR 1X EVERY TWO WEEKS TO ADULTS WHO HAVE BEEN ADMINISTERED ESKETAMINE IN A INDUCTION PHASE FOR ABOUT 4 WEEKS

International Family Members for US Patent 11,173,134

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015318123
Canada	2961208
China	107208133