PERSERIS KIT Drug Patent Profile

Which patents cover Perseris Kit, and what generic alternatives are available?

Perseris Kit is a drug marketed by Indivior and is included in one NDA. There are ten patents protecting this drug.

This drug has thirty-eight patent family members in seventeen countries.

The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Perseris Kit

A generic version of PERSERIS KIT was approved as risperidone by RISING on October 8^th, 2008.

Summary for PERSERIS KIT

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERSERIS KIT
DailyMed Link:	PERSERIS KIT at DailyMed

Recent Clinical Trials for PERSERIS KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indivior Inc.	Phase 4

See all PERSERIS KIT clinical trials

US Patents and Regulatory Information for PERSERIS KIT

PERSERIS KIT is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No	9,186,413
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes	9,597,402		Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No	11,013,809		Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No	10,376,590
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes	10,406,160		Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes	9,180,197		Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No	10,010,612		Y

EU/EMA Drug Approvals for PERSERIS KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for PERSERIS KIT

See the table below for patents covering PERSERIS KIT around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	581862	Injectable subcutaneous formulation comprising risperidone capable of forming a solid, microporous implant in a patient
Japan	2013139479	SUSTAINED RELEASE DELIVERY FORMULATION OF RISPERIDONE COMPOUND
Israel	190499
Taiwan	200803920
China	101365423	Sustained release small molecule drug formulation
European Patent Office	1940351
China	101801415	Sustained delivery formulations of risperidone compounds

Supplementary Protection Certificates for PERSERIS KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PERSERIS KIT

Last updated: July 31, 2025

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Introduction

PERSERIS KIT, a long-acting injectable formulation of risperidone, addresses unmet needs in schizophrenia and bipolar disorder management. Its unique delivery method via a subcutaneous autoinjector offers advantages over oral and other injectable formulations. The evolving landscape of treatment options, regulatory environment, and healthcare payor considerations significantly influence PERSERIS KIT’s market trajectory and financial performance.

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Market Overview and Demographic Drivers

The global antipsychotic market, projected to reach USD 15.3 billion by 2027 (CAGR ~3.5%), is predominantly driven by the increasing prevalence of schizophrenia and bipolar disorder. Schizophrenia affects approximately 20 million people worldwide, with onset typically in early adulthood, creating a consistent demand for effective maintenance therapies (WHO, 2022).

The introduction of long-acting injectable (LAI) formulations like PERSERIS KIT aligns with clinical trends emphasizing adherence improvement, relapse reduction, and quality-of-life enhancement. Patients with chronic psychiatric conditions often face adherence challenges, leading to hospitalization and increased healthcare costs. PERSERIS KIT’s once-monthly dosing simplifies treatment regimens, making it attractive for both clinicians and patients.

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Competitive Landscape and Market Positioning

The LAI antipsychotic segment features established brands such as Risperdal Consta, Invega Sustenna, and Abilify Maintena. PERSERIS KIT, with its auto-injector design approved in the U.S. in 2020, aims to differentiate through ease of use and patient comfort. However, market penetration depends on factors like prescriber acceptance, patient preference, and formulary inclusion.

Key competitors have entrenched market share, but PERSERIS benefits from a focus on reducing injection-related discomfort and administration anxiety—attributes increasingly valued in patient-centric models. Additionally, PERSERIS offers a potentially favorable pricing position given the market’s tilt towards cost-effective therapies amid evolving insurance policies.

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Regulatory and Reimbursement Trajectory

Regulatory approvals across multiple regions form the backbone of commercialization. The FDA’s greenlight in 2020 and subsequent listings in formularies influence sales. Conversely, delays or restrictions in other markets, such as Europe or Asia, slow revenue growth.

Reimbursement strategies are critical. PERSERIS KIT’s coverage under Medicare, Medicaid, and private insurers significantly impact patient access and sales volume. Negotiations with payors are often challenging, especially for innovator biologics and device-based therapies. As healthcare systems move towards value-based care, PERSERIS’s demonstrated reduction in relapse rates and hospitalization offers performance-based reimbursement opportunities.

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Market Adoption and Prescriber Engagement

Adoption depends on prescriber familiarity, comfort, and clinical outcomes data. The initial clinical trials demonstrated non-inferiority to oral risperidone with added benefits in adherence. Ongoing post-marketing studies and real-world evidence (RWE) will further influence clinician confidence.

Patient acceptance is also pivotal. The autoinjector’s discreet design and minimally invasive delivery may enhance compliance. Educational initiatives and support programs could accelerate adoption, especially in outpatient settings and community clinics.

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Pricing and Revenue Forecasts

Pricing of PERSERIS KIT is expected to be aligned with existing LAIs, typically ranging from USD 1,000 to USD 2,500 per dose in the U.S. Given the chronic nature of disease, sustained purchasing is anticipated. Based on prevalence data and adherence improvements, revenue projections suggest a compound annual growth rate (CAGR) of approximately 8-12% over five years post-market entry.

Market penetration will initially be concentrated in regions with high healthcare expenditure, expanding as the product gains formulary acceptance and clinician trust. Strategic partnerships with healthcare providers and payors can amplify uptake.

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Challenges Impacting Financial Performance

• Regulatory Hurdles: Stringent approval processes can delay market entry and revenue realization.
• Pricing Pressures: Increasing emphasis on cost containment may suppress allowable pricing premiums.
• Generic Competition: Although LAIs currently lack extensive generic options, biosimilar and generic risperidone formulations could emerge, impacting margins.
• Patient and Prescriber Resistance: Resistance due to unfamiliarity or preference for oral therapies may slow growth.

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Future Growth Drivers

• Expanded Indications: Potential approval for bipolar disorder and off-label uses could broaden market scope.
• Formulation Innovations: Development of shorter-acting or combination formulations could enhance treatment options.
• Digital Health Integration: Leveraging digital adherence monitors and telepsychiatry can improve outcomes and reduce costs, bolstering PERSERIS KIT’s value proposition.
• Geographic Expansion: Entry into European and Asian markets, subject to approval, presents significant upside given rising mental health awareness.

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Key Takeaways

1. Targeted Market Growth: PERSERIS KIT’s success hinges on increasing acceptance of LAI antipsychotics driven by adherence benefits and relapse reduction.

2. Regulatory and Reimbursement Strategies: Navigating diverse regulatory landscapes and securing favorable formulary placements are essential to maximizing sales.

3. Competitive Positioning: Differentiation through device design and patient convenience informs its market share relative to entrenched competitors.

4. Pricing and Cost-Effectiveness: Maintaining competitive pricing aligned with demonstrated clinical benefits is critical in a cost-conscious healthcare environment.

5. Expansion Opportunities: Broader indications and international expansion promise substantial long-term revenue possible trajectories.

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FAQs

Q1: How does PERSERIS KIT compare to other risperidone LAIs in terms of efficacy?
A1: Clinical trials indicate non-inferiority to existing risperidone LAIs, with added benefits in adherence due to its autoinjector design, potentially reducing relapse rates more effectively.

Q2: What are the primary barriers to PERSERIS KIT’s market adoption?
A2: Barriers include prescriber familiarity, formulary coverage limitations, patient preferences for oral options, and competition from established LAI formulations.

Q3: How will reimbursement trends influence PERSERIS KIT’s sales growth?
A3: Favorable reimbursement, reflecting its value in reducing hospitalization and relapses, will facilitate broader access and increase sales. Conversely, reimbursement restrictions can hinder market penetration.

Q4: What pricing strategies are likely sustainable for PERSERIS KIT?
A4: Pricing aligned with existing LAIs, complemented by demonstrating cost savings through reduced hospitalization, will be key. Value-based reimbursement models may also support premium pricing.

Q5: What future regulatory approvals could impact the financial trajectory?
A5: Approvals for broader indications like bipolar disorder, and international market clearances, will significantly expand the revenue base, supporting sustained growth.

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References

1. World Health Organization. (2022). Schizophrenia Fact Sheet.
2. MarketWatch. (2022). Global Antipsychotic Drugs Market Analysis.
3. FDA. (2020). Approval of PERSERIS for Schizophrenia.
4. IQVIA. (2022). Biopharmaceutical Market Dynamics.
5. Journal of Clinical Psychiatry. (2021). Adherence and Relapse in Schizophrenia.