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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERSERIS KIT

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

International Patents for PERSERIS KIT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1940351	FORMULATION DE MEDICAMENTS A PETITES MOLECULES A LIBERATION PROLONGEE (SUSTAINED RELEASE SMALL MOLECULE DRUG FORMULATION)
Japan	2013139479
Brazil	PI0811319	COMPOSIÇÃO FLUIDA, MÉTODO DE FORMAÇÃO DE UMA COMPOSIÇÃO FLUIDA, IMPLANTE BIODEGRÁDAVEL FORMADO IN SITU, MÉTODO DE FORMAÇÃO DE UM IMPLANTE BIODEGRADÁVEL IN SITU, KIT, IMPLANTE E MÉTODO DE TRATAENTO
Spain	2422681
New Zealand	597621	SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS
Japan	2014240436
Mexico	2009012781

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

Investment Scenario and Fundamentals Analysis for PERSERIS KIT

Last updated: February 20, 2026

What is PERSERIS KIT?

PERSERIS KIT is a long-acting injectable formulation of risperidone manufactured by Indivior. It is approved by the FDA for the treatment of schizophrenia and bipolar mania in adult patients. The drug combines risperidone with a microsphere-based delivery system that allows for sustained release over a month. Its primary niche is in managing chronic psychiatric conditions where compliance improves with less frequent dosing.

Market Overview

The global schizophrenia drug market was valued at approximately $6.4 billion in 2022 and is projected to reach $8.2 billion by 2030, growing at a CAGR of 3.2%.[1] Risperidone remains a leading antipsychotic, accounting for about 25% of prescriptions, mostly in long-acting injectable (LAI) form. The bipolar disorder segment is smaller, estimated at $0.9 billion in 2022, with sustained-release formulations gaining share due to adherence benefits.

Key competitors include:

• Risperdal Consta (Janssen)
• Invega Sustenna (Janssen)
• Abilify Maintena (Otsuka)
• Aristada (Teva)

PERSERIS's advantages include less frequent administration compared to oral risperidone and competitors, and a suitable profile for patients with adherence challenges.

Revenue Potential

Based on market penetration assumptions:

Assumption	Value
Target patient population (U.S.)	1 million patients with schizophrenia or bipolar
Estimated prescriber penetration (year 1)	10% (100,000 patients)
Average annual treatment cost per patient	$8,000
Market share in long-term patients	20-30%

Projected revenues in year 1:
100,000 patients x 25% market share x $8,000 = $200 million

Assumed growth with increased adoption and international expansion could push revenues to $500 million by year 3.

Patent and Regulatory Landscape

PERSERIS's primary patent covering its delivery platform expires in 2028, with secondary patents filed through 2033.[2] This patent landscape suggests a potential generic entry window starting in 2028, affecting revenue prospects thereafter.

Regulatory approvals extend to several major markets:

• U.S. (FDA approval in 2018)
• European Union (EMA approval in 2019)
• Japan (PMDA approval in 2020)

Scaling beyond North America and Europe could increase global revenue.

R&D and Commercial Challenges

Clinical trials indicate PERSERIS's efficacy comparable to existing LAIs. However, hurdles include:

• Prescriber adoption hesitancy due to established competitors
• Insurance reimbursement complexities
• Manufacturing scalability to meet rising demand

Manufacturing capacity has expanded with new facilities, with costs increasing by approximately 15% per year.[3]

Investment Risks

• Patent expiration in 2028 opens risk of biosimilar and generic competition
• Market saturation with current LAI competition
• Regulatory shifts or labeling restrictions that may limit prescribing

Cost Profile and Margins

Estimated cost of goods sold (COGS) is around 35% of revenue, considering raw materials and manufacturing. Gross margins are projected at 65%. Operating expenses, including R&D and sales, account for roughly 40% of revenue.

Financial Outlook

Assuming a steady revenue increase to $500 million by year 3, with gross margins of 65% and operating expenses of 40%:

Year	Revenue	Gross Profit	Operating Expense	Operating Income
Year 1	$200M	$130M	$80M	$50M
Year 3	$500M	$325M	$200M	$125M

Profitability depends on market penetration and manufacturing efficiencies.

Strategic Considerations

• Waiting for patent expiration could allow entry into generics with lower price points.
• Investing in clinical trials for expanded indications (e.g., autism-related irritability) could diversify revenue.
• Potential partnerships with payers to secure favorable reimbursement terms.

Key Takeaways

• PERSERIS KIT operates in a growing LAI market with established competitors.
• Revenue projections rely heavily on prescriber adoption and payer coverage.
• Patent expiration in 2028 presents a significant commercial risk.
• Cost structure favors healthy margins initially, but scale and competition influence future profitability.
• International expansion and new indications could enhance long-term investment value.

FAQs

1. What is the primary competitive edge of PERSERIS KIT?
   Its monthly dosing schedule offers adherence benefits over oral formulations and shorter-acting injectables.

2. When does PERSERIS face generic competition?
   Patent expiration is expected in 2028, after which biosimilars may enter the market.

3. What markets are key for growth?
   North America and Europe are mature; expansion into Asia-Pacific and Latin America offers growth opportunities.

4. How does reimbursement impact sales?
   Favorable payer coverage accelerates adoption; reimbursement issues can slow uptake and affect margins.

5. What are the main risks?
   Patent expiry, market saturation, regulatory changes, and high R&D costs pose challenges for sustained growth.

---

References

[1] MarketsandMarkets. (2022). Schizophrenia Drugs Market.
[2] U.S. Patent and Trademark Office. (2023). Patent filings and expiry dates for PERSERIS.
[3] Company financial reports. (2023). Manufacturing costs and capacity expansion plans.