Details for Patent: 11,013,809

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Which drugs does patent 11,013,809 protect, and when does it expire?

Patent 11,013,809 protects PERSERIS KIT and is included in one NDA.

This patent has eighteen patent family members in eleven countries.

Summary for Patent: 11,013,809

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 injected 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 Lindemann
Assignee:	Indivior UK Ltd
Application Number:	US16/509,287
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

US Patent 11,013,809: Risperidone PLGA Injectable Composition, Claim Scope and Patent Landscape

US Patent 11,013,809 covers a risperidone-base depot formulation using an 80/20 carboxy-terminated PLGA copolymer and a defined solvent system. Its strongest commercial relevance is the monthly subcutaneous risperidone platform used for long-acting treatment of schizophrenia and other psychiatric conditions. The claims reach the composition itself, specified polymer and solvent combinations, dose ranges, polymer molecular weights, and treatment methods that avoid supplemental oral risperidone.

The patent is more important as a formulation and delivery patent than as a broad risperidone compound patent. Its principal vulnerability is that claim 1 combines a narrow polymer limitation with a very broad Markush solvent list and numerous functional or approximate limitations in the dependent method claims.

What does US Patent 11,013,809 protect?

The independent composition claim requires every element below:

Required element	Claim limitation
Active ingredient	Risperidone base
Polymer	80/20 poly(DL-lactide-co-glycolide), or PLGA
Polymer end group	Carboxy terminal group
Solvent	At least one listed solvent or solvent combination
Physical form	Risperidone base in a solution comprising the polymer and solvent

The patent does not claim risperidone generally. It claims risperidone base dissolved or incorporated in a specific in situ depot formulation system.

The most commercially significant technical combination is:

• Risperidone base
• 80/20 carboxy-terminated PLGA
• N-methyl-2-pyrrolidone, or NMP
• Approximately 15 wt% risperidone
• Approximately 45 wt% PLGA
• Approximately 55 wt% solvent

Claim 10 narrows the formulation to the approximately 45/55 polymer-to-solvent ratio. Claims 6 through 9 progressively narrow the risperidone concentration, ending at approximately 15 wt%.

How broad is claim 1?

Claim 1 is broad in solvent selection but narrow in polymer identity.

The solvent Markush group includes NMP, dimethyl sulfoxide, dimethylformamide, acetone, ethyl acetate, triethyl citrate, benzyl alcohol, polyethylene glycol and many other organic solvents, plasticizers and solvent systems. A formulation using any one listed solvent, or a combination of listed solvents, can fall within the literal scope if the formulation also contains the required PLGA and risperidone base.

The polymer limitation materially narrows the claim. A competing product using:

• A different lactide:glycolide ratio;
• A lactide-rich or glycolide-rich PLGA;
• A polymer with an ester or alkyl terminal group;
• A polycaprolactone polymer;
• A non-PLGA biodegradable polymer; or
• A polymer mixture without the specified 80/20 carboxy-terminated PLGA

may avoid literal infringement of claim 1, subject to doctrine-of-equivalents analysis.

The phrase “80/20” is commercially important. It ordinarily refers to the lactide-to-glycolide composition ratio, but the claim text supplied does not state whether the ratio is measured by molar percentage, weight percentage or another polymer specification. That ambiguity creates a potential claim-construction issue.

What formulations are protected by US 11,013,809?

Core formulation limitations

The protected formulation space is defined by four variables:

1. Risperidone must be present as the base rather than a salt.
2. The polymer must be 80/20 PLGA with a carboxy terminal group.
3. The polymer must be present in a solution with a listed solvent.
4. The formulation must satisfy the relevant concentration and molecular-weight limitations when a dependent claim is asserted.

Claims 11 through 13 define broad composition ranges:

Parameter	Claimed range
PLGA in solution	About 10 wt% to about 70 wt%
Solvent in solution	About 10 wt% to about 70 wt%
Narrower PLGA range	About 20 wt% to about 70 wt%
Narrower solvent range	About 30 wt% to about 70 wt%
More specific PLGA range	About 40 wt% to about 50 wt%
More specific solvent range	About 50 wt% to about 60 wt%
Preferred disclosed ratio	About 45 wt% PLGA and 55 wt% solvent

Claims 14 and 15 cover PLGA average molecular weights from approximately 10,000 to 45,000 Daltons, with a narrower range of approximately 15,000 to 40,000 Daltons.

The patent therefore reaches a substantial formulation window, not only one commercial batch specification. A design-around would need to address both polymer chemistry and formulation proportions.

Solvent-specific claims

Claim 2 separately protects dimethyl sulfoxide. Claim 3 identifies a shorter solvent list that includes NMP, dimethyl sulfoxide, dimethylformamide, acetone, ethyl acetate, tributyl citrate, diethyl succinate, triethyl citrate, acetyl tributyl citrate, glyceryl triacetate, dimethylacetamide and epsilon-caprolactone.

These claims provide narrower fallback positions if claim 1 is challenged for undue breadth, lack of enablement or obviousness. They also make solvent substitution more difficult where a competing product uses one of the specifically recited solvents.

The repeated listing of isopropyl myristate and oleic acid in claim 1 appears to be drafting redundancy rather than a substantive expansion of scope.

What treatment methods are protected?

Claims 16 through 30 add method-of-treatment coverage.

The principal treatment claim requires administering the composition of claim 1 to treat schizophrenia. The method claims then cover:

• Subcutaneous injection;
• Once-monthly administration;
• Risperidone-base amounts of 30, 60, 90, 120 or 180 mg;
• Broader dose ranges of approximately 3 mg to 300 mg and 9 mg to 900 mg;
• Treatment without supplemental daily oral risperidone;
• No oral supplementation during the first 21 days;
• Therapeutic plasma levels immediately after injection;
• Steady-state plasma levels within four to six weeks.

Claim 28 extends treatment to schizophrenia, bipolar disorder, obsessive-compulsive disorder, Tourette syndrome and autistic spectrum disorder. Claims 29 and 30 separately identify bipolar disorder and autistic spectrum disorder.

The treatment claims are potentially more valuable than the composition claims in a commercial enforcement case because an accused manufacturer, distributor or healthcare provider may practice the method through the marketed dosing instructions even when the full formulation composition is not publicly disclosed.

What are the claim-drafting vulnerabilities?

Claim-category inconsistency

Claim 5 begins “The method provides steady-state risperidone plasma levels,” but depends directly on claim 1, which is a composition claim. This creates a formal claim-dependency problem. The limitation may be treated as an intended-use or functional limitation of the composition, but its scope and enforceability are less certain than a properly drafted method claim.

“About” limitations

Claims 4, 6 through 15 and 23 through 24 use “about” with dose, concentration, molecular-weight and formulation ranges. The legal scope depends on intrinsic evidence, specification examples, analytical variability and prosecution history. A competitor near a numerical boundary presents a claim-construction dispute rather than a clear noninfringement position.

Functional plasma-level limitations

Claims 5 and 27 use pharmacokinetic results:

• “Steady-state risperidone plasma levels from four to six weeks”
• “Therapeutic plasma risperidone levels immediately after injection”

These limitations may require clinical or pharmacokinetic evidence. “Immediately” and “therapeutic” are particularly susceptible to indefiniteness, written-description and proof-of-infringement disputes unless the specification defines them with measurable parameters.

Broad solvent genus

The solvent list is extensive and includes compounds with materially different polarity, miscibility, volatility and polymer-solubilization properties. A validity challenge could argue that the specification does not enable the entire genus without undue experimentation, particularly where the claim covers every listed solvent at broad concentrations.

The strength of that challenge depends on the disclosure of working examples, polymer-solvent compatibility data and predictable formulation principles.

Risperidone base versus risperidone salts

The claims require “risperidone base.” A formulation using a risperidone salt, prodrug or chemically modified risperidone derivative would have a strong literal noninfringement argument. The doctrine of equivalents could remain relevant, but the chemical distinction may be material because salt selection can alter solubility, loading and release behavior.

When does US Patent 11,013,809 lose exclusivity?

The patent issued on May 25, 2021. Patent expiration cannot be determined from the claim text alone because the term requires the patent’s earliest effective nonprovisional priority date, any terminal disclaimer, patent-term adjustment and any applicable patent-term extension. The USPTO patent record and Patent Center file control those calculations.[1]

The patent is separate from FDA regulatory exclusivity. FDA approval of a risperidone depot product does not automatically extend the patent term. Conversely, patent expiration does not remove FDA requirements for an abbreviated or hybrid application.

For commercial planning, the relevant timeline has four separate components:

Exclusivity layer	Relevant question
Patent term	When do claims 1-30 expire after statutory adjustments?
FDA Orange Book listing	Is the patent listed for an approved product and what use codes apply?
Regulatory exclusivity	Does the approved product have any remaining new-drug or other exclusivity?
Litigation or settlement	Has a Paragraph IV challenge been filed, and has entry been restricted by agreement?

The supplied information does not establish the patent’s current Orange Book listing, terminal disclaimer status, patent-term adjustment or litigation docket.

What is the Orange Book status of US Patent 11,013,809?

The Orange Book determines whether a patent is listed against a specific approved drug application, not whether a patent is valid or infringed generally. FDA listing data should be reviewed by application number, product name, patent number and use code.[2]

The relevant commercial product is Perseris, an extended-release injectable suspension of risperidone approved by FDA for the treatment of schizophrenia in adults. Perseris uses a subcutaneous depot delivery system and is administered once monthly at 90 mg or 120 mg of risperidone.[3]

The claim set aligns closely with those commercial characteristics:

• Monthly subcutaneous administration;
• 90 mg and 120 mg risperidone doses;
• No required oral supplementation;
• PLGA-based in situ depot formulation;
• Immediate therapeutic exposure after injection.

That alignment supports a high likelihood of product relevance, but Orange Book listing and use-code status must be determined from the current FDA database rather than inferred from claim similarity.

Which products and companies compete with this patent estate?

Perseris

Perseris is the closest product to the claimed formulation profile. It is an extended-release risperidone injection administered subcutaneously once monthly. The approved strengths are 90 mg and 120 mg, corresponding to approximately 50 mg and 75 mg oral risperidone-equivalent exposure, respectively, according to the product labeling.[3]

The patent claims cover the key commercial concept: risperidone base in a carboxy-terminated 80/20 PLGA/NMP-type depot solution.

Uzedy

Uzedy is another subcutaneous extended-release risperidone product. FDA approved it in 2023 for schizophrenia in adults. It offers monthly and every-two-month administration and has a different dose presentation and product-development history from Perseris.[4]

Uzedy creates a competing patent estate and a potential design-around benchmark. Its commercial relevance does not establish infringement of US 11,013,809. The analysis turns on polymer ratio, terminal group, solvent system, risperidone form, concentrations and manufacturing process.

Risperdal Consta

Risperdal Consta is an intramuscular microsphere formulation of risperidone associated with Janssen. It uses a different delivery architecture from the claimed in situ subcutaneous PLGA solution. It is not a direct formulation match for claim 1, although it competes in the long-acting risperidone market.[5]

Oral risperidone generics

Oral risperidone tablets, orally disintegrating tablets and oral solutions do not practice the asserted formulation claims. They may be relevant to method claims only if a generic product is used in a claimed treatment regimen, which is unlikely without the patented depot composition.

What generic entry risks exist?

A generic or follow-on applicant seeking to copy the claimed depot formulation would face four main risks.

Composition infringement

The highest risk exists where the product uses:

• Risperidone base;
• 80/20 carboxy-terminated PLGA;
• NMP or another listed solvent; and
• Similar polymer, solvent and drug concentrations.

A product that matches those features could infringe claim 1 even if it uses a different syringe, needle, manufacturing site or packaging configuration.

Method-of-use infringement

A product labeled for monthly subcutaneous schizophrenia treatment, without oral risperidone supplementation, could implicate claims 16 through 27. A label that includes bipolar disorder or autistic spectrum disorder could implicate claims 28 through 30, subject to FDA approval and divided-infringement issues.

Paragraph IV litigation

An abbreviated new drug application or applicable 505(b)(2) application may challenge listed patents through a Paragraph IV certification. The principal defenses would likely include:

• Noninfringement based on polymer ratio or terminal group;
• Use of risperidone salt rather than base;
• Different solvent system;
• Different dosing or administration schedule;
• Invalidity for obviousness;
• Lack of enablement across the solvent genus;
• Indefiniteness of “about,” “immediately” or “therapeutic.”

The existence, timing and outcome of any Paragraph IV notice or litigation cannot be established from the supplied claim text.

Manufacturing barriers

The formulation is difficult to copy without solving several technical problems:

• Dissolving high drug loads in the polymer-solvent system;
• Maintaining injectability;
• Controlling in situ precipitation and depot formation;
• Achieving reproducible release over one month;
• Controlling burst release;
• Maintaining polymer molecular weight and end-group consistency;
• Sterilizing or aseptically manufacturing the product;
• Establishing syringeability and product stability.

These manufacturing barriers may provide practical protection beyond the patent claims, particularly where a design-around changes the solvent or polymer chemistry but creates unacceptable release or injection performance.

How strong is the patent estate?

The patent has moderate-to-strong commercial relevance but a mixed litigation profile.

Issue	Assessment
Commercial relevance	High for monthly subcutaneous risperidone depots
Composition breadth	Moderate
Polymer specificity	Narrow and potentially design-aroundable
Solvent coverage	Broad
Dose coverage	Broad, with specific commercial strengths
Method-of-use coverage	Broad across several psychiatric disorders
Enablement risk	Meaningful because of the large solvent genus
Indefiniteness risk	Meaningful for functional and “about” limitations
Manufacturing leverage	High
Direct relevance to Perseris	Strong
Direct relevance to oral generics	Low
Direct relevance to competing depot products	Fact-dependent

The strongest enforceable positions are likely the narrower claims directed to the commercial formulation profile: 15 wt% risperidone, approximately 45 wt% PLGA, approximately 55 wt% solvent, and 90 mg or 120 mg monthly dosing. Those claims sacrifice breadth but may be easier to tie to a marketed product and supporting examples.

How does US 11,013,809 compare with competing risperidone patents?

US 11,013,809 is differentiated by its combination of:

• In situ depot formulation;
• Subcutaneous administration;
• Monthly dosing;
• No required oral supplementation;
• Immediate therapeutic exposure;
• Specific PLGA end-group chemistry;
• Broad solvent alternatives.

Risperidone compound patents and oral formulation patents do not provide the same barrier. Microsphere patents covering intramuscular Risperdal Consta-type products use a different release platform. Competing subcutaneous products may rely on separate polymer compositions, dosing schedules, manufacturing methods or proprietary formulation parameters.

The competitive patent question is therefore not whether a company has a risperidone patent. It is whether the company’s product practices the precise PLGA, solvent, drug-form, concentration and dosing limitations in claims 1 through 30.

Key Takeaways

• US 11,013,809 is a formulation and method patent, not a basic risperidone compound patent.
• Claim 1 requires risperidone base, 80/20 carboxy-terminated PLGA and at least one listed solvent.
• The commercially important formulation profile is approximately 15 wt% risperidone, 45 wt% PLGA and 55 wt% solvent.
• Claims 16 through 30 add monthly subcutaneous treatment, dose, plasma-level and no-oral-supplementation limitations.
• Perseris is the product most closely aligned with the supplied claims.
• Uzedy is a major competing subcutaneous risperidone product with a separate development and patent profile.
• The principal validity risks are obviousness, enablement across the solvent genus, indefiniteness of functional terms and the malformed dependency of claim 5.
• The principal design-around routes are changing the PLGA ratio, terminal group, risperidone form, solvent system, administration route or dosing schedule.
• Orange Book listing, patent-term adjustment, terminal disclaimers, Paragraph IV activity and settlement restrictions require review of current FDA and USPTO records.

FAQs

Does US 11,013,809 cover oral risperidone tablets?

No. The claims require a risperidone-base PLGA solution. Conventional oral tablets, capsules and oral solutions do not meet the composition limitations.

Does the patent cover every risperidone injectable?

No. The polymer must be the claimed 80/20 carboxy-terminated PLGA, and the formulation must contain a listed solvent. An injectable using microspheres, a different polymer or a different active ingredient form may fall outside the literal claims.

Can a product avoid the patent by using a different PLGA molecular weight?

Potentially. Claims 14 and 15 cover specific molecular-weight ranges, but claim 1 itself, as provided, does not recite a molecular-weight limitation. A different molecular weight would not necessarily avoid claim 1 if all other limitations are met.

Does a two-month risperidone injection automatically avoid the patent?

No. Administration every two months may avoid the monthly limitations in certain method claims, but it does not automatically avoid the composition claims. The formulation still must be compared against claim 1 and the applicable dependent claims.

Is US 11,013,809 a biosimilar patent?

No. Risperidone is a small-molecule drug. The relevant competition involves generic, hybrid 505(b)(2), and follow-on long-acting injectable products rather than biosimilars under the Public Health Service Act.

References

1. United States Patent and Trademark Office. (2021). US Patent No. 11,013,809.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2018). Perseris (risperidone) extended-release injectable suspension prescribing information. Indivior Inc.
4. U.S. Food and Drug Administration. (2023). Uzedy (risperidone) extended-release injectable suspension prescribing information. Teva Pharmaceuticals USA, Inc.
5. U.S. Food and Drug Administration. (2003). Risperdal Consta (risperidone) long-acting injection prescribing information. Janssen Pharmaceuticals, Inc.

Drugs Protected by US Patent 11,013,809

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	11,013,809		Y			TREATING SCHIZOPHRENIA
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		DISCN	Yes	No	11,013,809		Y			TREATING SCHIZOPHRENIA

International Family Members for US Patent 11,013,809

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