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. 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 APOTEX INC on September 15^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 Applications:	4,018
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

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/005406 Treatment 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
European Patent Office	2152315	FORMULATIONS D'ADMINISTRATION PROLONGÉE DE COMPOSÉS DE RISPÉRIDONE (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS)
Spain	2385384
Japan	6216364
Japan	2013139479	SUSTAINED RELEASE DELIVERY FORMULATION OF RISPERIDONE COMPOUND
Canada	2624088	FORMULATION DE MEDICAMENTS A PETITES MOLECULES A LIBERATION PROLONGEE (SUSTAINED RELEASE SMALL MOLECULE DRUG FORMULATION)
Argentina	056554	FORMULACION DE FARMACO DE MOLECULA PEQUENA DE LIBERACION SOSTENIDA

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

PERSERIS KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PERSERIS KIT

Introduction

PERSERIS, a risperidone extended-release injection, has been a part of Indivior's product portfolio, but recent market dynamics and financial considerations have led to significant changes in its trajectory.

Historical Performance of PERSERIS

In the past, PERSERIS showed promising growth. For instance, in FY 2021, PERSERIS net revenue was $17 million, a 21% increase compared to FY 2020. Similarly, in Q4 2021, PERSERIS net revenue was $5 million, up 25% from Q4 2020[5].

Recent Market Dynamics

However, the market landscape for PERSERIS has become increasingly challenging. Key factors include:

Increased Payor Management

One of the primary reasons for the discontinuation of PERSERIS sales and marketing is the anticipated increase in payor management within the treatment category. This change is expected to make PERSERIS no longer financially viable[1][3][4].

Competitive Market

The market for schizophrenia treatments is highly competitive, and impending changes in payor management have intensified this competition. Indivior has determined that there is no longer a viable path forward for PERSERIS in this environment[1][4].

Medicaid Disenrollments

Although not directly related to PERSERIS, the broader impact of Medicaid disenrollments following the end of COVID-19 emergency measures has highlighted the volatility in healthcare coverage and reimbursement, further complicating the financial viability of certain products[4].

Financial Impact and Guidance

The decision to discontinue PERSERIS sales and marketing has significant financial implications:

Revenue Projections

For FY 2024, the net revenue guidance for PERSERIS has been set at $27 million to $33 million, which is a reduction from previous expectations. This reflects the immediate cessation of sales and marketing activities[1][3][4].

Cost Savings and Charges

Indivior expects to realize annual operating expense savings of around $50 million, with $20 million of these savings anticipated in the second half of 2024. However, the company will also incur a charge of approximately $65 million, of which $20 million is cash-related, primarily for severance and termination of certain agreements. This will result in the loss of around 130 jobs[1][4].

Adjusted Operating Profit and Margin

Despite the challenges, Indivior continues to expect solid adjusted operating profit growth and adjusted operating margin expansion. For FY 2024, the adjusted operating profit is guided between $285 million to $320 million, with an adjusted operating margin expansion of approximately 100 basis points compared to FY 2023[1][3].

Strategic Implications

The discontinuation of PERSERIS is part of a broader strategic realignment by Indivior:

Focus on Core Products

Indivior is focusing on its core products, particularly SUBLOCADE, which continues to show strong growth. For FY 2024, SUBLOCADE net revenue is expected to be between $765 million to $805 million, representing a 25% increase at the midpoint compared to FY 2023[1][3][4].

New Product Launches

Indivior is also investing in new products like OPVEE (nalmefene) nasal spray, which, although showing modest initial revenue, is part of the company's long-term strategy to diversify its product portfolio[3].

Support for Patients and Employees

Indivior has committed to supporting patients and employees affected by the discontinuation of PERSERIS. The company will continue to supply PERSERIS to avoid disruption to patient care, even though it will no longer deploy a dedicated sales force for the product[1][4].

Key Takeaways

• Discontinuation of Sales and Marketing: PERSERIS sales and marketing activities have been ceased due to adverse market dynamics and increased payor management.
• Financial Impact: The decision will result in cost savings but also involves significant one-time charges and job losses.
• Strategic Focus: Indivior is focusing on core products like SUBLOCADE and new launches like OPVEE.
• Patient and Employee Support: The company will continue to supply PERSERIS to support ongoing patient care and will support affected employees through the transition.

FAQs

Q: Why did Indivior decide to discontinue PERSERIS? A: Indivior decided to discontinue PERSERIS due to expected adverse impacts from increased payor management that would make the product no longer financially viable[1][4].

Q: What are the financial implications of discontinuing PERSERIS? A: The discontinuation will result in a charge of approximately $65 million, with around $20 million being cash-related, and is expected to save around $50 million in annual operating expenses[1][4].

Q: How will the discontinuation of PERSERIS affect Indivior's overall financial guidance for FY 2024? A: The overall net revenue guidance for FY 2024 has been adjusted to $1.15 billion to $1.22 billion, with adjusted operating profit expected to be between $285 million to $320 million[1][3][4].

Q: What support will Indivior provide to patients and employees affected by the discontinuation of PERSERIS? A: Indivior will continue to supply PERSERIS to avoid disruption to patient care and will support affected employees through the transition[1][4].

Q: How does this decision align with Indivior's broader strategic goals? A: The decision aligns with Indivior's focus on its core products, such as SUBLOCADE, and new product launches, ensuring a strong and diversified product portfolio[1][3].

Sources

1. Indivior Provides Business Update; Conference Call at 8:00 AM U.S. EDT - Indivior
2. Indivior Q4 2022 Financial Results - Final - Indivior
3. Indivior H1 2024 Financial Results Final - Indivior
4. TOP NEWS: Indivior lowers 2024 outlook and calls time on Perseris - Morningstar
5. February 16, 2022 FY 2021 Financial Results Announced - Indivior