US Drug Patent 10,376,590: Claim Scope, Uzedy Protection, Expiration and Generic Entry Risk
US Patent No. 10,376,590 protects methods for treating schizophrenia with a subcutaneous risperidone depot formed from risperidone base, carboxy-terminated 80/20 poly(DL-lactide-co-glycolide) and N-methyl-2-pyrrolidone (NMP). The patent is method-of-treatment protection rather than a composition claim. Its commercial relevance is tied to Teva’s Uzedy extended-release injectable suspension, an FDA-approved subcutaneous risperidone product administered monthly or every two months.[1-3]
The strongest commercial coverage is concentrated in independent claims 1 and 33. Those claims require the combination of:
- Risperidone base;
- An 80/20 poly(DL-lactide-co-glycolide), or PLG/PLGA, copolymer;
- A carboxy terminal group on the copolymer;
- NMP as the solvent;
- Subcutaneous administration;
- Treatment of schizophrenia.
Dependent claims add dosing intervals, concentration ranges, polymer molecular weight, dose amounts, pharmacokinetic results and the absence of supplemental oral risperidone.
What does US Patent 10,376,590 cover?
US 10,376,590 covers a specific subcutaneous depot-delivery method for risperidone. Claim 1 is the principal broad claim, while claim 33 provides a second independent route with express concentration ranges.[1]
| Claim element |
Claim 1 requirement |
Claim 33 requirement |
| Therapeutic use |
Treating schizophrenia |
Treating schizophrenia |
| Active ingredient |
Risperidone base |
Risperidone base |
| Administration |
Subcutaneous injection |
Subcutaneous injection |
| Polymer |
80/20 poly(DL-lactide-co-glycolide) with carboxy terminal group |
Same |
| Solvent |
NMP |
NMP |
| Risperidone concentration |
Not expressly limited in claim 1 |
About 10 wt% to about 30 wt% |
| Polymer concentration |
Added in dependent claims |
About 10 wt% to about 70 wt% |
| NMP concentration |
Added in dependent claims |
About 10 wt% to about 70 wt% |
| Dosing |
Added in dependent claims |
Monthly dosing in claim 34 |
A product or method must satisfy every required limitation of an asserted claim. A risperidone product administered intramuscularly, delivered orally, or formulated with a polymer other than the specified 80/20 carboxy-terminated PLGA would not literally meet claim 1 solely because it contains risperidone.
How strong is the independent claim coverage?
Claim 1 has substantial formulation specificity but broad therapeutic and dosing language. It does not require a particular dose, monthly schedule or exact concentration. The claim can potentially reach a range of subcutaneous risperidone depot regimens if the formulation uses the specified polymer and NMP system.
Claim 33 is narrower in one respect because it requires approximately 10 wt% to 30 wt% risperidone base. It is also more commercially focused because that range is consistent with the concentration profile associated with the Uzedy platform.
The principal claim vulnerabilities are claim construction and enablement issues involving:
- The meaning of “80/20” PLGA;
- The scope of “having a carboxy terminal group”;
- Whether the claimed weight percentages are measured against the entire composition or only the solution phase;
- Whether the pharmacokinetic limitations in dependent claims are definite and reproducible;
- Whether the specification enables the full dose and concentration ranges;
- Whether a competing product uses a materially different polymer end group or lactide-to-glycolide ratio.
The claims do not require every commercial characteristic of Uzedy. A challenger could therefore focus on formulation identity, polymer chemistry, claim construction or written-description support rather than disputing the general concept of long-acting subcutaneous risperidone.
What formulations are protected by US 10,376,590?
The patent protects formulations containing risperidone base in a solution of carboxy-terminated 80/20 PLGA and NMP. The most specific formulation appears in claim 23:
- Approximately 15 wt% risperidone base;
- Approximately 45 wt% 80/20 carboxy-terminated PLGA;
- Approximately 55 wt% NMP.
Claims 24 through 32 apply additional treatment and dose limitations to that formulation.
| Formulation feature |
Relevant claims |
| Risperidone base, about 10-50 wt% |
Claim 4 |
| Risperidone base, about 10-30 wt% |
Claim 5 |
| Risperidone base, about 10-20 wt% |
Claim 6 |
| PLGA and NMP each about 10-70 wt% |
Claim 7 |
| PLGA about 20-70 wt%; NMP about 30-70 wt% |
Claim 8 |
| PLGA about 40-50 wt%; NMP about 50-60 wt% |
Claim 9 |
| PLGA molecular weight about 10,000-45,000 Da |
Claim 10 |
| PLGA molecular weight about 15,000-40,000 Da |
Claim 11 |
| 15 wt% risperidone, 45 wt% PLGA and 55 wt% NMP |
Claim 23 |
The concentration limitations create overlapping numerical ranges. For example, claim 6 is narrower than claim 5, and claim 9 is narrower than claims 7 and 8. The overlapping structure gives the patent multiple fallback positions if a broad range is challenged.
What dose and dosing schedules are covered?
The patent covers both monthly administration and a 28-day administration schedule. Claims 2 and 3 are directed to those intervals. The dose-dependent claims identify risperidone base amounts of 30 mg, 60 mg, 90 mg, 120 mg and 180 mg. Claims 21 and 22 extend the dose range to approximately 3-300 mg and 9-900 mg, respectively.[1]
The relevant claims are:
| Clinical parameter |
Covered claims |
| Every 28 days |
Claim 2 |
| Once per month |
Claim 3 |
| About 30 mg |
Claims 18 and 28 |
| About 60 mg |
Claims 19 and 29 |
| About 90 mg |
Claims 12 and 35 |
| About 120 mg |
Claims 13 and 36 |
| About 180 mg |
Claims 20 and 30 |
| About 3-300 mg |
Claims 21 and 31 |
| About 9-900 mg |
Claims 22 and 32 |
The claims do not expressly require a two-month dosing interval. Uzedy’s FDA-approved labeling includes monthly and every-two-month administration, but the patent claims supplied here are more directly aligned with monthly or 28-day treatment.[2]
Does the patent cover treatment without oral risperidone supplementation?
Yes. Claims 14, 15, 24, 25, 37 and 38 cover methods in which the patient is not given supplemental daily oral risperidone. Claims 15, 25 and 38 are limited to the first 21 days after treatment begins.
This limitation is commercially important because the FDA labeling for Uzedy states that no oral risperidone supplementation is required when initiating treatment in appropriate patients previously stabilized on oral risperidone.[2] A competing product requiring oral supplementation could avoid these claims, but it could still implicate the broader independent claims if the formulation and administration limitations are met.
What pharmacokinetic outcomes are claimed?
Claims 16, 17, 26, 27, 39 and 40 claim treatment methods that provide:
- Therapeutic risperidone plasma levels immediately after injection; and
- Steady-state risperidone plasma levels from four to six weeks.
These are functional treatment limitations. Their enforcement value depends on how a court construes “therapeutic plasma risperidone levels,” “immediately after injection” and “steady-state risperidone plasma levels.” The terms may require clinical or pharmacokinetic evidence rather than simple product-composition testing.
A generic or follow-on applicant could face factual infringement exposure if its product produces the claimed plasma profile and otherwise satisfies the formulation and administration limitations. The same limitations may create validity questions if the patent specification does not provide an adequate technical basis across the full claimed range.
What is the FDA and Orange Book status of US 10,376,590?
The commercial product associated with the claimed technology is Uzedy, risperidone extended-release injectable suspension, marketed by Teva Pharmaceuticals. FDA approved Uzedy on April 28, 2023, for the treatment of schizophrenia in adults.[2,3]
Uzedy is administered subcutaneously and uses the MedinCell BEPO long-acting injectable platform. The FDA label identifies risperidone as the active ingredient and lists PLGA and NMP among the formulation components.[2]
US 10,376,590 is an Orange Book-listed patent associated with Uzedy. The listing gives Teva an important basis for addressing an abbreviated new drug application that certifies under Paragraph IV against the patent.[4]
FDA exclusivity
Uzedy received FDA approval in 2023. The product is a small-molecule drug, so it is subject to Hatch-Waxman generic competition rather than a biosimilar pathway. The standard five-year new chemical entity exclusivity applicable to a qualifying new active moiety does not necessarily apply to a new dosage form of the previously approved active ingredient risperidone. Uzedy’s principal market protection therefore depends on patent rights, regulatory complexity and manufacturing know-how rather than biologic exclusivity.
When does US Patent 10,376,590 lose exclusivity?
The patent’s statutory term is generally measured from the earliest effective nonprovisional filing date, subject to patent-term adjustment and any applicable patent-term extension. Public patent records identify a 2014 priority framework for the family. On that basis, the ordinary statutory expiration is expected to fall in late 2034, subject to the USPTO-calculated term.[1,5]
| Event |
Date or status |
| Patent issued |
August 13, 2019 |
| Patent number |
US 10,376,590 B2 |
| FDA approval of Uzedy |
April 28, 2023 |
| Expected ordinary patent-term window |
Approximately late 2034 |
| Relevant regulatory pathway |
NDA, Hatch-Waxman |
| Biosimilar exclusivity |
Not applicable |
The issue date does not determine expiration. A patent issued in 2019 can expire earlier or later depending on its earliest effective filing date, continuation practice, patent-term adjustment and terminal disclaimers.
Which companies are challenging US 10,376,590?
No public Paragraph IV challenge or federal patent litigation against US 10,376,590 is identified in the materials provided. A definitive current litigation conclusion cannot be drawn from the claim text alone.
The likely challenger universe includes:
- Generic drug manufacturers developing long-acting risperidone injections;
- Specialty injectable companies pursuing 505(b)(2) applications;
- Developers of alternative PLGA/NMP depot systems;
- Companies seeking to compete with Uzedy through a different route of administration or polymer platform.
A conventional oral risperidone generic is not a direct infringement threat because it would not meet the subcutaneous injection and depot formulation limitations. A competing long-acting injectable presents a materially higher risk, particularly if it uses the same PLGA/NMP approach.
What generic entry risks exist for Uzedy?
The most credible entry scenarios are:
1. Formulation substitution
A competitor could use a different solvent, polymer end group, lactide-to-glycolide ratio or delivery platform. This is the clearest design-around route because the claims require both 80/20 PLGA and NMP.
2. Different administration route
An intramuscular risperidone depot would avoid the express subcutaneous limitation, although it would compete clinically with different products such as Risperdal Consta rather than directly replicate Uzedy.
3. Different dosing or concentration
Changing the concentration alone may not avoid claim 1, because claim 1 has no express concentration limitation. It could avoid narrower claims, including claims 5, 6 and 23, but not necessarily the independent claim.
4. Paragraph IV certification
A generic applicant could certify that the patent is invalid, unenforceable or not infringed. For a complex injectable, the applicant would need to address formulation sameness, device or administration requirements and FDA requirements for injectable suspensions.
5. 505(b)(2) application
A 505(b)(2) applicant could rely partly on FDA’s findings for Uzedy while proposing a modified formulation, dosing regimen or clinical use. This route may avoid some composition overlap but would not automatically eliminate patent risk.
How does the patent estate compare with competing risperidone products?
| Product |
Sponsor |
Route |
Typical schedule |
Competitive relationship |
| Uzedy |
Teva/MedinCell platform |
Subcutaneous |
Monthly or every two months |
Directly aligned with US 10,376,590 |
| Perseris |
Indivior |
Subcutaneous |
Monthly |
Competes in long-acting SC risperidone |
| Risperdal Consta |
Janssen |
Intramuscular |
Every two weeks |
Different route and depot technology |
| Oral risperidone generics |
Multiple manufacturers |
Oral |
Daily |
Low direct infringement risk |
| Rykindo |
Luye Pharma |
Intramuscular |
Extended interval |
Different route and formulation |
Perseris is the closest commercial comparator because it is also a monthly subcutaneous risperidone product. Its formulation platform and patent estate are distinct from the PLGA/NMP technology claimed in US 10,376,590. The existence of Perseris does not by itself establish noninfringement because infringement depends on the specific polymer, solvent, concentration and treatment method.
What manufacturing and intellectual-property barriers protect the product?
The main barriers are technical rather than limited to the issued claims:
- Reproducible manufacture of injectable PLGA depots;
- Control of polymer molecular weight and terminal chemistry;
- Sterile processing and injectable viscosity;
- Consistent in situ depot formation after subcutaneous injection;
- Stability of risperidone base in NMP;
- Dose uniformity across prefilled syringes;
- Release-rate control over monthly and two-month intervals;
- Clinical demonstration of adequate exposure without oral supplementation.
A competitor can avoid literal claim coverage but still face FDA development costs, clinical comparability requirements, manufacturing scale-up risk and separate patent families covering formulation process, device, dosing or pharmacokinetic performance.
Key Takeaways
- US 10,376,590 is a method patent centered on subcutaneous risperidone in 80/20 carboxy-terminated PLGA dissolved in NMP.
- Claims 1 and 33 are the principal independent claims.
- The patent covers monthly and 28-day administration, with dependent claims covering specific doses and concentration ranges.
- Claims directed to no oral supplementation and immediate therapeutic exposure are commercially relevant to Uzedy’s treatment protocol.
- Uzedy was FDA-approved in April 2023 and is associated with the patent in the Orange Book.
- The ordinary patent-term window is approximately late 2034, subject to USPTO term calculations.
- Oral risperidone generics present little direct infringement risk.
- The highest-risk competitors are subcutaneous long-acting risperidone products using the same PLGA/NMP platform.
- The clearest design-around strategies involve changing the polymer chemistry, solvent, route of administration or depot technology.
- Risperidone is a small molecule; biosimilar competition is not the applicable pathway.
FAQs
Is US 10,376,590 a composition patent?
No. The supplied claims are method-of-treatment claims. They require subcutaneous injection of a specified risperidone formulation to treat schizophrenia.
Does US 10,376,590 cover Uzedy’s every-two-month regimen?
The supplied claims expressly recite every-28-day and monthly administration, but not a two-month interval. Other patents in the Uzedy estate may address longer dosing intervals.
Can an oral risperidone generic infringe US 10,376,590?
Ordinarily no. The claims require subcutaneous injection of the specified depot formulation.
Is Perseris covered by US 10,376,590?
Perseris is a competing subcutaneous risperidone product, but infringement depends on its actual polymer, solvent, terminal group, concentration and method of use. Product-level comparison is required.
Is a biosimilar application relevant to Uzedy?
No. Uzedy contains the small-molecule drug risperidone. Competition would proceed through an ANDA, 505(b)(2) application or another small-molecule pathway, not a biosimilar application.
References
- United States Patent and Trademark Office. (2019). US Patent No. 10,376,590 B2: Methods of treating schizophrenia using risperidone.
- U.S. Food and Drug Administration. (2023). Uzedy (risperidone) extended-release injectable suspension prescribing information. Teva Pharmaceuticals USA, Inc.
- U.S. Food and Drug Administration. (2023, April 28). FDA approves extended-release injectable suspension for treatment of schizophrenia in adults.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- United States Code. (2024). 35 U.S.C. §§ 154 and 156. Patent term and patent-term extension provisions.
