Details for Patent: 11,712,475

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Which drugs does patent 11,712,475 protect, and when does it expire?

Patent 11,712,475 protects PERSERIS KIT and is included in one NDA.

This patent has eighteen patent family members in eleven countries.

Summary for Patent: 11,712,475

Title:	Sustained delivery formulations of risperidone compound
Abstract:	The present invention relates to a risperidone sustained release delivery system for treatment of medical conditions relating to delusional psychosis, schizophrenia, bipolar disorder, psychotic depression, obsessive-compulsion disorder, Tourette syndrome, and autistic spectrum disorders. The sustained release delivery system includes a flowable composition containing risperidone, a metabolite, or a prodrug thereof and an implant containing risperidone, a metabolite, or a prodrug thereof. The flowable composition may be infected into tissue whereupon it coagulates to become a solid or gel, monolithic implant. The flowable composition includes a biodegradable, thermoplastic polymer, an organic liquid, and risperidone, a metabolite or a prodrug thereof.
Inventor(s):	Eric Dadey, Qi Li, Christopher M. Lindemann
Assignee:	Indivior UK Ltd , Tolmar Therapeutics Inc
Application Number:	US17/237,207
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

US Drug Patent 11,712,475: Claim Scope, Perseris Protection, Exclusivity and Generic Risk

US Patent No. 11,712,475 is a formulation-specific method-of-treatment patent covering subcutaneous administration of risperidone in a biodegradable poly(DL-lactide-co-glycolide), or PLGA, depot system. The claims are directed to the formulation and clinical-use profile associated with monthly Perseris risperidone extended-release injection, including 90 mg and 120 mg doses, immediate post-injection exposure, steady-state plasma levels within four to six weeks, and the absence of supplemental oral risperidone.

The patent does not broadly cover every risperidone injectable, every PLGA formulation, or every method of treating schizophrenia. Its commercial significance comes from the combination of narrowly defined formulation ratios, dose ranges, injection frequency, and treatment protocol limitations.

What does US Patent 11,712,475 protect?

The independent claim requires all of the following elements:

Claim element	Required limitation
Disease	Schizophrenia
Patient	Subject in need of treatment
Route	Subcutaneous injection
Active ingredient	Risperidone base
Risperidone concentration	About 15 wt%
Polymer	About 45 wt% of 80/20 poly(DL-lactide-co-glycolide)
Polymer end group	Carboxy terminal group
Solvent	About 55 wt% N-methyl-2-pyrrolidone, or NMP
Dosage	Dependent claims specify approximately 90 mg or 120 mg
Frequency	Monthly administration
Oral supplementation	No supplemental daily oral risperidone, including during the first 21 days
Pharmacokinetics	Immediate therapeutic plasma levels and steady-state levels in four to six weeks

Claim 1 is the principal commercial claim. It combines composition and treatment limitations in a single method claim. A potentially infringing product would need to practice the full combination, not merely use risperidone or a PLGA depot independently.

The patent is therefore best characterized as a product-specific clinical-use patent with formulation limitations.

How do claims 1 through 12 differ?

Claims 2 through 12 narrow claim 1 and create multiple infringement positions.

Claim	Scope	Practical significance
1	Broadest independent method claim	Requires the specified risperidone, PLGA, NMP formulation and subcutaneous schizophrenia treatment
2	Exact 15/45/55 wt% formulation	Removes some flexibility created by “about” language
3	Approximately 90 mg or 120 mg	Covers both commercial dose quantities identified in the claim set
4	Approximately 90 mg	Protects the lower claimed dose independently
5	Approximately 120 mg	Protects the higher claimed dose independently
6	Polymer molecular weight of about 10,000 to 45,000 Daltons	Broad molecular-weight limitation
7	Polymer molecular weight of about 15,000 to 40,000 Daltons	Narrower and potentially more defensible range
8	Once-per-month injection	Aligns the claim with monthly maintenance treatment
9	No supplemental daily oral risperidone	Removes oral overlap as a required treatment component
10	No supplemental oral risperidone during the first 21 days	Targets the absence of an oral loading or bridging period
11	Therapeutic levels immediately after injection	Covers the initial pharmacokinetic profile
12	Steady-state levels in four to six weeks	Covers the claimed maintenance pharmacokinetic profile

The dependent claims have different litigation value. Claims 4, 5, 8, 9, and 10 are commercially important because they track recognizable treatment features. Claims 6 and 7 are technically important because polymer molecular weight can distinguish otherwise similar PLGA formulations.

What commercial product is most closely associated with the patent?

The claim structure corresponds closely to Perseris, an extended-release subcutaneous risperidone product approved by the FDA in 2018. Perseris contains 90 mg or 120 mg of risperidone and is administered once monthly. The FDA label states that oral risperidone supplementation is not required for initiation of treatment. [2]

Perseris is supplied as a drug-device or kit-based product in which the polymer and solvent system form a depot after subcutaneous administration. The formulation relies on PLGA and NMP to create sustained release rather than using a preformed microsphere suspension.

The claim language also distinguishes Perseris from other long-acting risperidone products:

Product	Active ingredient	Route	Formulation approach	Typical schedule
Perseris	Risperidone	Subcutaneous	In situ PLGA/NMP depot	Monthly
Risperdal Consta	Risperidone	Intramuscular	Microsphere depot	Every two weeks
Uzedy	Risperidone	Subcutaneous	Extended-release injectable suspension	Monthly or every two months
Rykindo	Risperidone	Intramuscular	Microsphere depot	Every two weeks

The existence of another subcutaneous risperidone product does not, by itself, establish infringement. The relevant questions are whether the competing product has the claimed polymer, solvent, concentration, dose, molecular-weight range, treatment schedule, and clinical-use characteristics.

What formulation is protected by US 11,712,475?

The core formulation is:

• 15 wt% risperidone base;
• 45 wt% 80/20 poly(DL-lactide-co-glycolide);
• carboxy-terminal PLGA;
• 55 wt% NMP.

The 80/20 designation generally refers to the lactide-to-glycolide composition ratio. The carboxy terminal group is material because polymer end-group chemistry affects degradation, water uptake, drug release, and depot behavior.

NMP is the solvent component. Following injection, the solvent exchanges with surrounding aqueous tissue fluid, causing the polymer system to precipitate or solidify into a depot. The resulting matrix controls risperidone release over the intended monthly interval.

The claims use “about,” which introduces ordinary claim-construction flexibility. The scope is not automatically limited to laboratory measurements exactly equal to 15%, 45%, and 55%. A court would evaluate the term in light of the specification, prosecution history, analytical method, and evidence regarding formulation tolerances.

Claims 6 and 7 create a second technical boundary. A competing formulation with the same nominal weight percentages may avoid literal infringement if its PLGA molecular weight falls outside the claimed range. That distinction may not eliminate risk if other patent claims, equivalents arguments, or separate Orange Book-listed patents apply.

Does the patent cover all subcutaneous risperidone injections?

No. The patent does not facially cover:

• intramuscular risperidone products;
• oral risperidone;
• risperidone formulations using a different polymer;
• formulations using a different solvent;
• products containing risperidone at materially different concentrations;
• products administered at a materially different frequency;
• treatments for indications other than schizophrenia, unless another claim or patent applies;
• formulations that require oral risperidone supplementation if the challenged use relies on claims 9 or 10.

A competitor using a different PLGA ratio, a non-carboxy terminal polymer, another solvent, a different risperidone concentration, or a preformed microsphere could reduce exposure under these claims. That competitor would still need to assess related patents covering the delivery platform, manufacturing process, device, dosage form, or treatment method.

What is the patent expiration date and exclusivity timeline?

US Patent 11,712,475 issued on August 1, 2023. The statutory patent term is generally measured from the earliest effective nonprovisional filing date for the relevant family, subject to patent-term adjustment, terminal disclaimers, and any patent-term extension. [1]

The issue date does not determine the expiration date. The relevant term must be taken from the USPTO patent record and the applicable family prosecution history. Orange Book listing data, if applicable to the approved product, is the operational reference for ANDA certification and regulatory exclusivity analysis. [3]

The product-level timeline is:

Event	Date or status
Perseris FDA approval	July 27, 2018
Patent 11,712,475 issuance	August 1, 2023
Patent type	Method-of-treatment and formulation-specific
FDA exclusivity type	New drug exclusivity associated with the approved NDA, separate from patent rights
Generic pathway	ANDA, subject to applicable patent certifications
Biosimilar pathway	Not applicable because risperidone is a small molecule
Key commercial barrier	Complex subcutaneous depot formulation and clinical-use claim set

FDA approval exclusivity and patent exclusivity operate separately. A patent may remain enforceable after regulatory exclusivity expires. Conversely, expiration of a patent does not remove other patents that cover the product, manufacturing process, delivery device, or approved use.

What is the Orange Book status of Perseris and this patent?

The Orange Book determines whether a patent is listed against an approved drug product and whether an ANDA applicant must make a Paragraph I, II, III, or IV certification. [3]

For a listed method-of-use patent, an ANDA applicant may use a section viii statement to carve out the patented use if the remaining label does not require the protected method. That strategy is more difficult where the patent claims correspond closely to the product’s central labeled treatment protocol.

A Paragraph IV certification would assert that the listed patent is invalid, unenforceable, or not infringed. The NDA holder or patent owner generally has 45 days to file an infringement action, which can trigger a 30-month stay of ANDA approval under the Hatch-Waxman framework. [4]

The practical Orange Book questions are:

1. Is 11,712,475 listed against Perseris?
2. Is the listing directed to the entire product, a method of use, or a specific formulation?
3. Does the ANDA applicant need a Paragraph IV certification or can it use a section viii carve-out?
4. Are other patents listed against the same NDA?
5. Has the patent been delisted, disclaimed, terminally disclaimed, or challenged?

The answers must be assessed against the current Orange Book entry and the approved labeling. A single patent cannot be treated as the complete Perseris estate.

How strong are the claims against a generic challenger?

The patent has meaningful commercial strength because it claims a recognizable product profile rather than only a broad therapeutic concept. The strongest features are the combined limitations:

• 90 mg or 120 mg monthly dose;
• 15/45/55 wt% formulation;
• carboxy-terminal 80/20 PLGA;
• NMP solvent;
• no oral risperidone bridge;
• immediate therapeutic exposure;
• four-to-six-week steady-state profile.

A generic applicant could attack the patent through several routes.

Noninfringement

The applicant could design around one or more limitations, for example by:

• changing the PLGA lactide/glycolide ratio;
• using a polymer with a different terminal group;
• selecting a molecular weight outside the claimed ranges;
• altering the risperidone concentration;
• using a different solvent;
• administering intramuscularly;
• using a dosing interval outside monthly treatment;
• including a supplemental oral regimen.

Invalidity

Potential validity issues include:

• anticipation by earlier risperidone depot formulations;
• obviousness based on known PLGA/NMP injectable systems;
• lack of written description for the full “about” ranges;
• enablement of the claimed pharmacokinetic outcomes;
• indefiniteness of terms such as “therapeutic plasma risperidone levels” and “immediately after injection.”

The pharmacokinetic limitations may provide both value and vulnerability. They can distinguish prior art, but they may also raise questions about objective boundaries and whether the claimed results are inherent in every formulation within the composition ranges.

Method-of-treatment enforcement

Method claims are generally enforced against the party that induces or directs the claimed use. Label content is important. If a generic label instructs physicians to use the product monthly without oral supplementation for schizophrenia, that label can support an induced-infringement theory.

A skinny-label strategy may reduce risk if the patented treatment steps can be omitted without undermining approval or prescribing information. The commercial feasibility of that approach depends on the remaining approved indications and dosing instructions.

Are biosimilar challenges relevant?

No. Risperidone is a chemically synthesized small molecule, not a biologic. A competing manufacturer would use the ANDA pathway rather than the biosimilar pathway under the Public Health Service Act.

The relevant regulatory and litigation mechanisms are:

• ANDA approval;
• patent certifications under 21 U.S.C. § 355(j)(2)(A)(vii);
• Paragraph IV litigation;
• section viii method-of-use carve-outs;
• 30-month stay provisions;
• possible 180-day first-filer exclusivity.

The complex depot formulation may make approval more difficult than approval of a conventional oral risperidone tablet. FDA may scrutinize comparative performance, in vitro release, device operation, injection characteristics, and clinical or pharmacokinetic bridging.

What patents may compete with or supplement 11,712,475?

The relevant Perseris landscape is likely to include several patent categories:

Patent category	Subject matter	Risk to a competitor
Composition patents	Risperidone, PLGA, NMP formulation	Direct product coverage
Depot-platform patents	In situ precipitation and sustained release	May cover alternative formulations
Polymer patents	PLGA ratio, end group, molecular weight	Limits polymer design-around options
Dose patents	90 mg and 120 mg administration	Covers commercial dose levels
Method-of-use patents	Monthly schizophrenia treatment	Supports label-based infringement
Pharmacokinetic patents	Immediate exposure and steady state	May capture product performance
Device patents	Syringe, mixing, reconstitution, injection delivery	Creates manufacturing and device barriers
Manufacturing patents	Mixing, filling, sterilization, and kit assembly	Raises supply-chain entry costs

Patent 11,712,475 should therefore be analyzed as one layer of a product estate. A design-around that avoids this patent may still infringe an earlier formulation patent or a later device or manufacturing patent.

What licensing deals affect the patent landscape?

The formulation uses a known class of biodegradable polymer-solvent depot technology. Commercial rights may be divided among the NDA holder, formulation developer, polymer supplier, device manufacturer, or technology licensor. The existence of a technology license does not necessarily appear in the patent claims or Orange Book.

Freedom-to-operate analysis should distinguish:

• ownership of 11,712,475;
• rights to practice the PLGA/NMP delivery platform;
• rights to manufacture the polymer or solvent system;
• rights to use proprietary injection devices;
• rights to commercialize Perseris in particular territories.

No license should be inferred solely from the formulation chemistry or the identity of the marketing authorization holder.

What geographic coverage does the patent provide?

US 11,712,475 provides protection in the United States only. Foreign counterparts require separate validation and national-phase or direct-filing analysis. Key jurisdictions for a risperidone depot product include:

• European Patent Convention states;
• Canada;
• Japan;
• China;
• Australia;
• South Korea;
• Brazil.

Patent term, claim scope, prosecution amendments, opposition history, and enforceability can differ materially by country. A US design-around does not establish freedom to operate in Europe or other markets.

What generic launch scenarios exist?

Scenario 1: No ANDA challenge before patent expiry

The product remains protected by the listed patent estate, and generic entry is delayed until patent expiry or settlement-based entry.

Scenario 2: Paragraph IV challenge

A first filer challenges validity or infringement. Litigation may trigger the 30-month stay. The outcome depends on claim construction, prior art, formulation testing, and the approved label.

Scenario 3: Section viii carve-out

A generic applicant removes the patented schizophrenia treatment method from its labeling. This route is more viable if the product has an unpatented indication or dosing use that supports ANDA approval.

Scenario 4: Formulation redesign

A competitor changes polymer chemistry, solvent, concentration, dose, or route. This can avoid literal infringement but may require new clinical and CMC work.

Scenario 5: Settlement

A settlement could provide an agreed future launch date, license, or supply arrangement. Settlement terms may be subject to FTC scrutiny under the Hatch-Waxman antitrust framework. [5]

Key Takeaways

• US 11,712,475 is a narrow but commercially targeted patent covering monthly subcutaneous risperidone treatment.
• The claims are closely aligned with the 90 mg and 120 mg Perseris dosing regimen.
• The core formulation is approximately 15 wt% risperidone, 45 wt% carboxy-terminal 80/20 PLGA, and 55 wt% NMP.
• The patent also claims the absence of oral risperidone supplementation and specified pharmacokinetic outcomes.
• It does not broadly cover all risperidone injections or all PLGA depot systems.
• A generic challenge would likely focus on noninfringement, obviousness, anticipation, indefiniteness, and the availability of a section viii carve-out.
• Biosimilar litigation is not relevant because risperidone is a small molecule.
• The patent must be assessed with the broader Perseris estate, current Orange Book listings, regulatory exclusivity, device rights, and manufacturing patents.
• Patent 11,712,475 issued August 1, 2023. Its enforceable expiration must be determined from the USPTO patent-term record and any terminal disclaimer or patent-term adjustment.
• The principal commercial risk is a complex injectable generic that reproduces the formulation and monthly clinical-use profile closely enough to trigger Paragraph IV litigation.

FAQs

Does US 11,712,475 cover Uzedy?

Not on the face of the supplied claims. Uzedy is also subcutaneous risperidone, but infringement depends on its exact polymer, solvent, concentration, molecular weight, dosing schedule, and labeled treatment instructions.

Can a generic avoid the patent by adding oral risperidone?

Possibly, but adding oral supplementation would not automatically avoid claim 1. Claims 9 and 10 expressly require the absence of supplemental oral risperidone, while claim 1 contains the formulation and treatment limitations without that negative limitation.

Are 90 mg and 120 mg the only protected doses?

They are the only specific dose quantities recited in the supplied claims. Claim 1 does not itself state a dose quantity, and claim 3 uses “about 90 mg or about 120 mg.” Other patents may protect additional doses or dosing schedules.

Can a competitor use the same polymer with a different solvent?

That could avoid the literal NMP limitation in claims 1 and 2. The competitor would still need to evaluate related patents covering the polymer system, depot formation, manufacturing process, device, or treatment method.

Does FDA approval prove that the product infringes the patent?

No. FDA approval addresses safety, efficacy, quality, and regulatory requirements. Patent infringement depends on the asserted claims, product composition, labeling, manufacturing conduct, and applicable US patent law.

References

1. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,712,475, Methods of treating schizophrenia.
2. U.S. Food and Drug Administration. (2018). Perseris prescribing information: Risperidone extended-release injectable suspension.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
4. Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355(j).
5. Federal Trade Commission. (2023). Agreements filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

Drugs Protected by US Patent 11,712,475

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		DISCN	Yes	No	11,712,475					TREATING SCHIZOPHRENIA
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		DISCN	Yes	No	11,712,475					TREATING SCHIZOPHRENIA

International Family Members for US Patent 11,712,475

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008262545
Brazil	PI0811319
Canada	2687979
China	101801415
European Patent Office	2152315
European Patent Office	2907524
Spain	2562878