RISPERDAL Drug Patent Profile

When do Risperdal patents expire, and what generic alternatives are available?

Risperdal is a drug marketed by Janssen Pharms and is included in four NDAs.

The generic ingredient in RISPERDAL 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 Risperdal

A generic version of RISPERDAL was approved as risperidone by APOTEX INC on September 15^th, 2008.

Summary for RISPERDAL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	157
Patent Applications:	2,286
Drug Prices:	Drug price information for RISPERDAL
Drug Sales Revenues:	Drug sales revenues for RISPERDAL
What excipients (inactive ingredients) are in RISPERDAL?	RISPERDAL excipients list
DailyMed Link:	RISPERDAL at DailyMed

See drug prices for RISPERDAL

See drug sales revenues for RISPERDAL

Recent Clinical Trials for RISPERDAL

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

Sponsor	Phase
Lyndra Inc.	Phase 3
University of Chicago	Phase 4
University of Texas Southwestern Medical Center	Phase 4

See all RISPERDAL clinical trials

Pharmacology for RISPERDAL

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for RISPERDAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for RISPERDAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	AA	RX	Yes	Yes
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003		DISCN	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-004	Dec 29, 1993	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	AB	RX	Yes	No

Expired US Patents for RISPERDAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-004	Dec 23, 2004
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-003	Dec 29, 1993
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-005	Dec 29, 1993
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999

EU/EMA Drug Approvals for RISPERDAL

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 RISPERDAL

See the table below for patents covering RISPERDAL around the world.

Country	Patent Number	Title	Estimated Expiration
Estonia	03549	Kiirestilagunevad kaksikkumerad doseerimisvormid
Portugal	910345
Japan	H02191276	NOVEL 3-PIPERIDINYL-1,2-BENZISOXAZOLE
Hong Kong	1019200
Denmark	168537
Germany	68922577
Russian Federation	2131244	HARD DOZED FORM

Supplementary Protection Certificates for RISPERDAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	07C0044	France		PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0368388	SPC/GB07/065	United Kingdom		PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0196132	SPC/GB93/036	United Kingdom		SPC/GB93/036:, EXPIRES: 20071207
0368388	78/2007	Austria		PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0368388	91362	Luxembourg		91362, EXPIRES: 20141030
0368388	C300298	Netherlands		PRODUCT NAME: PALIPERIDON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIE ZOUT; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

RISPERDAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Risperdal

Introduction to Risperdal

Risperdal, known generically as risperidone, is an atypical antipsychotic medication approved by the FDA in 1993 for the treatment of various psychiatric disorders, including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. This article delves into the market dynamics and financial trajectory of Risperdal, highlighting key drivers, challenges, and future outlook.

Market Size and Growth

The global risperidone market, which includes Risperdal, was valued at approximately USD 545.10 million in 2022 and is anticipated to grow at a CAGR of 5.13% through 2028[2][3].

Key Market Drivers

Soaring Prevalence of Psychiatric Disorders

The increasing prevalence of psychiatric disorders such as schizophrenia and bipolar disorder is a primary driver of the Risperdal market. These conditions affect millions globally, necessitating long-term treatment with antipsychotic medications. The rising awareness of mental health disorders and initiatives aimed at reducing stigma have encouraged more individuals to seek treatment, thereby boosting the demand for medications like Risperdal[1][2][3].

Advancements in Healthcare Infrastructure and Diagnostics

Advancements in healthcare infrastructure and diagnostic capabilities have facilitated earlier diagnosis and intervention, driving market growth. Improved diagnostics enable ongoing monitoring and adjustments in treatment plans, expanding the pool of potential Risperdal users[3].

Cultural Shifts in Mental Health Awareness

A notable shift in societal attitudes towards mental health, marked by growing awareness and destigmatization efforts, has significantly influenced market dynamics. Governments and healthcare organizations worldwide are launching initiatives to promote mental health awareness and support, fostering a conducive market environment for psychiatric drugs like Risperdal[3].

Market Segment Analysis

Schizophrenia Treatment

The Risperdal market exhibits distinct regional dynamics influenced by healthcare infrastructure, regulatory frameworks, and prevalence rates of psychiatric disorders. North America, particularly the United States, stands as the largest regional market due to robust healthcare expenditures, extensive insurance coverage, and a high prevalence of psychiatric illnesses[1].

Regional Market Analysis

• North America: Driven by high awareness of mental health issues and comprehensive healthcare reimbursement systems, North America is the largest market for Risperdal. The region has seen substantial strides in reducing stigma around mental health, leading to increased demand for psychiatric medications[2][3].

• Europe: Europe follows closely, characterized by a preference for evidence-based medicine and stringent regulatory oversight. Countries such as Germany, France, and the UK are major contributors to the European market[1].

• Asia-Pacific: The Asia-Pacific region is poised to be the fastest-growing market for Risperdal. Growing awareness of mental health issues, destigmatization efforts, and investments in healthcare infrastructure are driving this growth. Countries like China, India, and Japan are witnessing greater acceptance of psychiatric treatments, including antipsychotic medications[2][3].

Route of Administration

The oral segment of risperidone administration dominates the market, with tablets and oral solutions being the most common forms. However, long-acting injectable forms are also gaining traction, particularly for the treatment of schizophrenia and bipolar disorder in adults[2].

End-Users and Distribution Channels

Hospitals are the largest end-users of Risperdal, followed by homecare, specialty clinics, and ambulatory surgical centers. The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies being the most significant[2].

Financial Trajectory

The risperidone market is part of the broader antipsychotic drugs market, which was valued at $16.14 billion in 2023 and is projected to grow to $26.48 billion by 2032. The third generation of antipsychotic drugs, which includes risperidone, is expected to see significant growth due to new product launches and technological advancements[3].

Challenges and Opportunities

Side Effects and Compliance

Despite its efficacy, Risperdal is associated with several side effects, including extrapyramidal symptoms (EPS), hyperprolactinemia, and metabolic changes. These side effects can lead to noncompliance with treatment, which is a major challenge for market growth. However, advancements in treatment modalities and the development of new therapeutic approaches are creating opportunities for more comprehensive and safer treatment regimens[2].

Regulatory Approvals and Market Access

International regulatory approvals for expanded indications and applications of Risperdal are opening up new markets and patient populations. This, combined with strategies to make the medication more accessible in developing regions, is expected to drive market growth[2].

Patient Affordability and Access

To address the issue of affordability, programs like the Janssen CarePath Savings Program offer financial assistance to patients, helping them manage out-of-pocket costs associated with Risperdal treatment. Such initiatives are crucial in ensuring that patients have access to necessary medications without financial barriers[2].

Future Outlook

The future outlook for the Risperdal market is shaped by evolving healthcare paradigms, technological advancements, regulatory trends, and shifting patient demographics. Antipsychotic medications like Risperdal are expected to continue playing a crucial role in the treatment of psychiatric disorders, driven by the increasing prevalence of conditions such as schizophrenia, bipolar disorder, and autism spectrum disorder globally.

Geographically, emerging markets in Asia-Pacific, Latin America, and the Middle East & Africa are poised for significant growth, driven by expanding healthcare infrastructure, increasing awareness of mental health disorders, and rising healthcare expenditures. However, market expansion in these regions will require navigating diverse regulatory environments, addressing cultural attitudes towards mental health, and ensuring affordability and accessibility of medications[1].

Key Industry Developments

• Research and Development: Janssen Pharmaceuticals continues to invest in research to explore new indications and formulations for Risperdal, enhancing its market resilience[1].

• Generic Versions: Generic versions of Risperdal have received regulatory approvals, increasing market competition and affordability[1].

• Regulatory Updates: Regulatory agencies issue safety warnings and updates regarding the use of Risperdal in certain patient populations, influencing market dynamics[1].

• Legal and Litigation Issues: Legal settlements and litigation impact brand reputation and market dynamics for Risperdal and its generics[1].

Key Takeaways

• The global risperidone market is expected to grow at a CAGR of 5.13% through 2028.
• The market is driven by the increasing prevalence of psychiatric disorders, cultural shifts in mental health awareness, and government initiatives.
• Expanded indications and therapeutic modalities are enhancing market resilience.
• North America is the largest market, while the Asia-Pacific region is expected to be the fastest-growing.
• Side effects and compliance issues are significant challenges, but advancements in treatment modalities offer opportunities for growth.
• Regulatory approvals and affordability programs are crucial for market expansion and patient access.

FAQs

Q1: What are the primary indications for Risperdal?

Risperdal is primarily indicated for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder[2].

Q2: Which region is the largest market for Risperdal?

North America, particularly the United States, is the largest regional market for Risperdal due to robust healthcare expenditures and extensive insurance coverage[1][2].

Q3: What are the common side effects associated with Risperdal?

Common side effects include extrapyramidal symptoms (EPS), hyperprolactinemia, and metabolic changes, which can lead to noncompliance with treatment[2].

Q4: How are regulatory approvals impacting the Risperdal market?

International regulatory approvals for expanded indications and applications of Risperdal are opening up new markets and patient populations, driving market growth[2].

Q5: What initiatives are in place to improve patient affordability and access to Risperdal?

Programs like the Janssen CarePath Savings Program offer financial assistance to patients, helping them manage out-of-pocket costs associated with Risperdal treatment[2].

Sources

1. Data Horizzon Research: Risperdal Market Size, Share, Growth, Statistics Report 2033.
2. Drug Patent Watch: Generic RISPERIDONE INN entry, drug patent expiration.
3. TechSci Research: Risperidone Market By Size, Growth, Trends and Forecast 2028.
4. ISPOR: The Allocation of the Economic Value of Second-Generation Antipsychotics Over the Product Life Cycle: The Case of Risperdal in Sweden and the United Kingdom.
5. Data Bridge Market Research: Risperidone Market Size, Share, Industry Trends & Forecast 2029.