RISPERIDONE - Generic Drug Details

What are the generic drug sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Teva, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Esjay Pharma, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fifty-four NDAs. There are thirty-eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has three hundred and thirty-two patent family members in forty-three countries.

There are thirty drug master file entries for risperidone. Thirty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RISPERIDONE

International Patents:	332
US Patents:	38
Tradenames:	7
Applicants:	44
NDAs:	54
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	557
Patent Applications:	7,021
Drug Prices:	Drug price trends for RISPERIDONE
Drug Sales Revenues:	Drug sales revenues for RISPERIDONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISPERIDONE
What excipients (inactive ingredients) are in RISPERIDONE?	RISPERIDONE excipients list
DailyMed Link:	RISPERIDONE at DailyMed

See drug prices for RISPERIDONE

See drug sales revenues for RISPERIDONE

Recent Clinical Trials for RISPERIDONE

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

Sponsor	Phase
Instituto de Salud Carlos III	Phase 4
Assiut University	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4

See all RISPERIDONE clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RISPERIDONE

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for RISPERIDONE

Antipsychotic Agents

Dopamine Antagonists

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for RISPERIDONE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RISPERIDONE

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 RISPERIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	078464-005	Apr 8, 2013	AB	RX	No	No
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	No			Y
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-001	Apr 28, 2023		RX	Yes	No			Y
Chartwell Molecular	RISPERIDONE	risperidone	TABLET;ORAL	077543-004	May 18, 2011	AB	RX	No	No

Expired US Patents for RISPERIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007
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 CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007

EU/EMA Drug Approvals for RISPERIDONE

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 RISPERIDONE

Country	Patent Number	Title	Estimated Expiration
Singapore	185775	ANTIPSYCHOTIC INJECTABLE DEPOT COMPOSITION
Japan	2015523405
China	104363923	Risperidone or paliperidone implant formulation
Japan	5405825

Supplementary Protection Certificates for RISPERIDONE

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

RISPERIDONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Risperidone

Introduction to Risperidone

Risperidone, an atypical antipsychotic medication, was first approved by the FDA in 1993 for the treatment of various psychiatric disorders, including schizophrenia, bipolar disorder, and irritability associated with autistic disorder[2].

Market Size and Growth

The global risperidone market has demonstrated significant growth and is expected to continue this trend. As of 2022, the market was valued at approximately USD 545.10 million and is anticipated to grow at a CAGR of 5.13% through 2028[1].

Key Market Drivers

Soaring Prevalence of Psychiatric Disorders

The increasing prevalence of psychiatric disorders, driven by modern lifestyles and societal pressures, is a primary driver of the risperidone market. Improved diagnostics and reduced stigma around mental health issues have led to more individuals seeking treatment, thereby increasing the demand for medications like risperidone[1].

Cultural Shift and Mental Health Awareness

A notable shift in societal attitudes towards mental health, marked by growing awareness and destigmatization efforts, has encouraged earlier diagnosis and treatment. This cultural shift has significantly bolstered the market for psychiatric medications[1].

Government and Healthcare Initiatives

Governments and healthcare organizations are launching initiatives to promote mental health awareness and support, creating a conducive market environment for psychiatric drugs. These initiatives include expanded healthcare reimbursement systems, which ensure patients have access to necessary medications[1].

Expanded Indications and Therapeutic Modalities

Risperidone's indications have expanded beyond its initial approvals, allowing it to enter various psychiatric submarkets. The medication is often used in conjunction with other treatments, such as psychotherapy and behavioral therapies, enhancing its market resilience[1].

Global Expansion and Emerging Markets

The global risperidone market is expanding, with a focus on emerging markets. International regulatory approvals have facilitated market growth by allowing risperidone to enter new regions and serve larger patient populations. Pharmaceutical companies are adopting strategies such as partnerships and distribution agreements to make risperidone more accessible in developing regions[1].

Segmental Insights

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][4].

End-Users and Distribution Channels

Hospitals are the largest end-users of risperidone, 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[4].

Regional Market Analysis

North America

North America is the largest market for risperidone, driven by high awareness of mental health issues and comprehensive healthcare reimbursement systems. This region has seen substantial strides in reducing stigma around mental health, leading to increased demand for psychiatric medications[1][4].

Asia-Pacific

The Asia-Pacific region is poised to be the fastest-growing market for risperidone. Growing awareness of mental health issues, destigmatization efforts, and investments in healthcare infrastructure are driving this growth. Countries in this region are witnessing an increase in the target population, further fueling market expansion[1][4].

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, risperidone 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 risperidone 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[1].

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 risperidone treatment. Such initiatives are crucial in ensuring that patients have access to necessary medications without financial barriers[5].

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.

Frequently Asked Questions

Q1: What are the primary indications for risperidone?

• Risperidone is primarily indicated for the treatment of schizophrenia, bipolar I acute manic or mixed episodes, and irritability associated with autistic disorder[2].

Q2: What are the common side effects of risperidone?

• Common side effects include extrapyramidal symptoms (EPS), hyperprolactinemia, metabolic changes, and orthostatic hypotension[2].

Q3: How is the risperidone market expected to grow in the forecast period?

• The risperidone market is expected to grow at a CAGR of 5.13% through 2028, driven by increasing prevalence of psychiatric disorders and expanded indications[1].

Q4: Which region is expected to be the fastest-growing market for risperidone?

• The Asia-Pacific region is expected to be the fastest-growing market due to growing awareness of mental health issues and investments in healthcare infrastructure[1][4].

Q5: What initiatives are in place to help patients afford risperidone?

• Initiatives like the Janssen CarePath Savings Program provide financial assistance to patients, helping them manage out-of-pocket costs associated with risperidone treatment[5].

Sources:

1. TechSci Research - Risperidone Market By Size, Growth, Trends and Forecast 2028
2. NCBI Bookshelf - Risperidone - StatPearls
3. Fortune Business Insights - Antipsychotic Drugs Market Size, Share | Growth [2024-2032]
4. Data Bridge Market Research - Global Risperidone Market
5. Janssen CarePath - Helping Patients Afford RISPERDAL CONSTA®