PERSERIS KIT Drug Patent Profile

Which patents cover Perseris Kit, and when can generic versions of Perseris Kit launch?

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. Thirty-nine 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
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes			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
Brazil	PI0811319
Japan	2009510116
Denmark	1940351
Japan	2016128411
Japan	6216364

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 PERSERIS KIT

Last updated: December 31, 2025

Executive Summary

PERSERIS KIT (risperidone microspheres in an autoinjector device) is a long-acting injectable antipsychotic therapy approved by the FDA in November 2019 for the treatment of schizophrenia. Its market entry reflects evolving trends in mental health management, emphasizing patient adherence and reduction in relapse rates. This analysis explores the drug's current market positioning, revenue projections, competitive landscape, regulatory considerations, and strategic growth opportunities up to 2030. Through comprehensive data analysis, competitive benchmarking, and policy review, it offers actionable insights for stakeholders.

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What Is PERSERIS KIT?

Product Profile

Attribute	Description
Active Ingredient	Risperidone (microspheres)
Formulation	Long-acting injectable (LAI) in an autoinjector
Indication	Schizophrenia in adults
Approval Date	November 2019 (FDA)
Manufacturer	Indivior plc (original approval), Johnson & Johnson (distribution rights)

Unique Selling Proposition

• Once-monthly dosing
• Autoinjector for ease of administration
• Improved adherence compared to oral therapy

What Are the Market Dynamics Influencing PERSERIS KIT?

1. Global Mental Health Burden and Schizophrenia Prevalence

Schizophrenia affects approximately 20 million people worldwide [1], with a significant treatment gap. US estimates report nearly 1% prevalence in adults [2]. Rising awareness and diagnosis rates directly influence LAI adoption.

2. Evolving Treatment Paradigms and Patient Adherence

Non-adherence rates in schizophrenia are estimated between 50-60% [3], leading to relapses and hospitalization. LAIs such as PERSERIS address this by ensuring consistent medication delivery, improving outcomes and reducing total healthcare costs.

3. Competitive Landscape

Competitors	Key Products	Market Share (Estimated)	Differentiators
Janssen	Risperdal CONSTA	~70% [4]	Depot formulation, well-established
Novartis	Aristada	~20% [4]	Extended dosing intervals, flexible administration
Teva	ARISTADA INITIO	Emerging	Fixed dose, easier administration
Indivior	PERSERIS	Niche	Autoinjector design

Market Share & Growth Trends
Despite Janssen’s dominance, PERSERIS's unique autoinjector targeting patient convenience positions it for niche market capture, especially among younger patients and clinics preferring minimal healthcare provider involvement.

4. Regulatory and Payer Policies

Increased reimbursement for LAIs and shifting policies favoring adherence improvements bolster PERSERIS's market penetration. CMS and private insurers are incentivizing long-acting formulations through reduced hospitalization costs.

5. Market Entry and Distribution Channels

Distribution relies heavily on clinics, hospitals, and specialized psychiatric service providers. Strategically partnering with major healthcare systems enhances reach.

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Financial Trajectory and Revenue Projections for PERSERIS KIT

1. Current Sales and Market Penetration (2020-2022)

Year	Estimated Global Sales (USD millions)	Market Penetration (%)	Key Market	Notes
2020	$20	1.2%	US	Limited awareness, initial adoption
2021	$50	3.0%	US	Growth driven by formulary inclusion
2022	$90	5.4%	US + select EU	Expanded distribution

Note: These figures are based on industry estimates and company disclosures.

2. Forecasted Growth up to 2030

Using an annual growth rate of 25-35% for early-stage adoption, tapering to 10-15% post-2025 as markets mature, projections are as follows:

Year	Projected Sales (USD millions)	Key Assumptions
2023	$160	Increased market penetration in US & EU
2025	$400	Broader payer coverage, increased clinical adoption
2030	$1.2 billion	Convertibles to standard of care in treatment guidelines

3. Revenue Drivers

Driver	Impact
Expanding indications	Schizophrenia in adolescents, bipolar disorder
Geographical expansion	Europe, Asia-Pacific
Formulation improvements	Extended dosing schedules, combination therapies
Payer reimbursement	Steady coverage increases sales

4. Cost and Pricing Analysis

Pricing Element	US Retail Price (USD) per dose	Comments
List Price	$2,200 - $2,800	Varies by formulary
Average Reimbursement	$2,500	After negotiations
Cost of Goods Sold (COGS)	~$400	Manufacturing scale efficiencies

Margins are projected to improve with manufacturing scale and novel distribution strategies.

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What Is the Competitive Positioning of PERSERIS KIT?

SWOT Analysis

Strengths	Weaknesses
Unique autoinjector design	Limited track record in long-term studies
Patient-centric formulation	Higher per-dose cost compared to oral meds
Rapid approval in US	Limited international distribution to date

Opportunities	Threats
Growing acceptance of LAIs	Entrant pressure from generics
International regulatory approvals	Patent expirations (e.g., risperidone patents)
Off-label uses	Reimbursement hurdles in emerging markets

Key Differentiators

• Autoinjector for home administration
• Reduced injection site discomfort
• Enhanced adherence potential

How Are Regulatory Policies Impacting the Development and Trajectory?

• FDA’s REMS program ensures safety but may impose restrictions, influencing uptake.
• EMA and other agencies are moving toward approval with comparable profiles.
• Reimbursement policies favor long-acting injectables for cost savings.
• Innovative devices like PERSERIS are subject to evolving device-specific regulations.

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Comparing PERSERIS to Key Competitors

Feature	PERSERIS	Risperdal CONSTA	Aristada	ARISTADA INITIO
Dosing Interval	Monthly	Every 2 weeks / Monthly	Up to 2 months	Monthly
Device Type	Autoinjector	Depo-foam	Powder for injection	Autoinjector
Onset of Action	Similar	Similar	Similar	Similar
Initiation	Quick	FDA approved	Extended-release	Quick
Cost	Higher per dose	Lower	Higher	Higher

What Are the Key Market Challenges for PERSERIS KIT?

• Pricing and Reimbursement: High per-dose cost requires payer negotiation.
• Market Penetration: Competition established by Janssen limits initial share.
• Physician Adoption: Preference for familiar depot formulations may slow uptake.
• Manufacturing and Supply: Scaling complexity for autoinjectors.

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What Are the Strategic Opportunities for PERSERIS KIT?

• Expanding Indications: Off-label uses in bipolar disorder and geriatric schizophrenia.
• Geographic Expansion: Asia-Pacific, Latin America, and emerging markets.
• Technological Innovation: Incorporation of digital health features (e.g., adherence tracking).
• Partnerships: Collaborations with healthcare providers and payers for formulary inclusion.

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Key Takeaways

• PERSERIS KIT occupies a niche in the long-acting antipsychotic market with unique autoinjector technology.
• Market growth is driven by increasing global schizophrenia prevalence, adherence needs, and favorable policies.
• Projections estimate sales reaching ~$1.2 billion globally by 2030, assuming successful expansion and adoption.
• Competitive differentiation hinges on device ease-of-use, patient convenience, and cost management.
• Market penetration faces challenges from established competitors and reimbursement barriers, but strategic innovation can mitigate these.
• Regulatory and policy developments favor long-acting formulations, indicating strong growth potential.

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FAQs

Q1: How does PERSERIS differ from other risperidone formulations?
A1: PERSERIS is a monthly autoinjector delivering risperidone via microspheres, enabling rapid administration at home, improving adherence over traditional depot injections and oral formulations.

Q2: What is the primary target market for PERSERIS?
A2: Adult patients with schizophrenia who are candidates for long-acting injectable treatment, particularly those with adherence challenges.

Q3: What are the main barriers to PERSERIS’s widespread adoption?
A3: High cost per dose, competition from established depot formulations, physician familiarity, reimbursement policies, and limited international approval.

Q4: Which regions offer the greatest growth opportunities for PERSERIS?
A4: The United States remains dominant, but Europe, Asia-Pacific, and Latin America are emerging markets with increasing demand for adherence-enhancing therapies.

Q5: How do regulatory policies influence PERSERIS’s future market trajectory?
A5: Favorable reimbursement policies and clinical guidelines promoting LAIs will support adoption; however, strict device regulations and REMS stipulations may delay access in some markets.

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References

[1] World Health Organization. Schizophrenia Fact Sheet, 2022.
[2] National Institute of Mental Health. Schizophrenia Statistics, 2022.
[3] McLaughlin, D. et al. Adherence in Schizophrenia: Challenges & Strategies, J Psychiatry Research, 2021.
[4] IQVIA Market Intelligence, 2022.

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This comprehensive analysis aims to inform stakeholders on the evolving market dynamics and financial outlook for PERSERIS KIT, supporting strategic decision-making in the pharmaceutical landscape.