Paliperidone - Generic Drug Details

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

Paliperidone is the generic ingredient in seven branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, Zydus Pharms, Luye Innomind Pharma, and Teva Pharms Usa, and is included in sixteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for paliperidone. Eighteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for paliperidone

US Patents:	7
Tradenames:	7
Applicants:	14
NDAs:	16
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	184
Patent Applications:	3,538
Drug Prices:	Drug price trends for paliperidone
What excipients (inactive ingredients) are in paliperidone?	paliperidone excipients list
DailyMed Link:	paliperidone at DailyMed

See drug prices for paliperidone

Recent Clinical Trials for paliperidone

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

Sponsor	Phase
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
Instituto de Salud Carlos III	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all paliperidone clinical trials

Generic filers with tentative approvals for PALIPERIDONE

Applicant	Application No.	Strength	Dosage Form
			SUSPENSION;EXTENDED RELEASE
		234MG/1.5ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
		156MG/ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

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 paliperidone

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for paliperidone

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for paliperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	AB	RX	Yes	No	9,439,906
Actavis Labs Fl Inc	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	202645-001	Aug 3, 2015		DISCN	No	No
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes	10,143,693
Ajanta Pharma Ltd	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	218514-004	Jun 26, 2024	AB	RX	No	No
Amneal Pharms	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	204707-002	Sep 23, 2019	AB	RX	No	No

Expired US Patents for paliperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008	5,158,952*PED
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006	5,158,952*PED
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006	5,158,952*PED
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006	5,158,952*PED
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-002	Dec 19, 2006	5,158,952*PED

EU/EMA Drug Approvals for paliperidone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Byannli (previously Paliperidone Janssen-Cilag International)	paliperidone	EMEA/H/C/005486 Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).	Authorised	no	no	no	2020-06-18
Janssen-Cilag International NV	Trevicta (previously Paliperidone Janssen)	paliperidone	EMEA/H/C/004066 Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.	Authorised	no	no	no	2014-12-05
Janssen-Cilag International N.V.	Xeplion	paliperidone	EMEA/H/C/002105 Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.	Authorised	no	no	no	2011-03-04
Janssen-Cilag International NV	Invega	paliperidone	EMEA/H/C/000746 Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.Invega is indicated for the treatment of schizoaffective disorder in adults.	Authorised	no	no	no	2007-06-24

Paliperidone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paliperidone

Market Overview

The paliperidone market is experiencing significant growth, driven by several key factors. Paliperidone, an atypical antipsychotic medication, is primarily used to treat schizophrenia, schizoaffective disorder, and other mental health conditions. Its efficacy and relatively favorable side-effect profile have made it a preferred treatment option[3].

Market Drivers

Increasing Prevalence of Schizophrenia and Other Psychotic Disorders

The growing prevalence of schizophrenia and other psychotic disorders is a major driver for the paliperidone market. According to the World Health Organization (WHO), schizophrenia affects approximately 20 million people worldwide, making it a leading cause of disability and premature mortality. This increasing incidence is attributed to genetic predisposition, environmental factors, and substance abuse[1].

Rising Demand for Effective and Safe Antipsychotic Medications

There is a rising demand for effective and safe antipsychotic medications, which is fueling the growth of the paliperidone market. Paliperidone extended-release tablets, in particular, offer consistent and prolonged therapeutic effects, improving patient compliance and treatment outcomes[1].

Growing Awareness and Investments in Mental Health

The increasing awareness about mental health disorders and the growing investments in healthcare infrastructure, especially in emerging markets like China, India, and Brazil, are also driving the demand for paliperidone. These markets are experiencing a rapid increase in the prevalence of mental health disorders, which is expected to increase the demand for effective and affordable antipsychotic medications[1].

Market Segmentation

Application Segments

The paliperidone market is segmented based on application, including extended-release tablets, injectable forms, oral tablets, and combination therapies. Extended-release tablets are particularly popular due to their once-daily formulation, which enhances patient compliance and treatment outcomes[4].

Product Segments

The market is also segmented by product type, including psychiatry, neurology, mental health clinics, and hospitals. The schizophrenia segment held the largest market share in 2021, accounting for over 60% of the total revenue, due to the high prevalence of schizophrenia and the widespread use of paliperidone extended-release tablets for its treatment[1].

Regional Analysis

North America

North America was the largest regional market for paliperidone extended-release tablets in 2021, accounting for over 40% of the global revenue. The high prevalence of mental health disorders, the presence of well-established healthcare infrastructure, and the increasing adoption of generic versions of paliperidone extended-release tablets are driving the growth of the market in this region[1].

Europe

Europe is the second-largest market, accounting for over 30% of the global revenue. The increasing prevalence of mental health disorders, rising awareness about early diagnosis and treatment, and the growing demand for effective and safe antipsychotic medications are driving the market growth in Europe[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth rate during the forecast period. This is due to the increasing prevalence of mental health disorders, rising disposable income of patients, and growing awareness about the importance of mental health treatment. The region's increasing adoption of Western lifestyles and growing exposure to environmental risk factors, such as urbanization and social isolation, are also contributing to the high burden of mental health disorders[1].

Financial Trajectory

Market Size and Growth

The global paliperidone extended-release tablets market is expected to reach USD 3.2 billion by 2033, growing at a CAGR of 5.5% during the forecast period (2021-2033)[1].

Revenue Projections

The broader paliperidone market was valued at USD 3.5 billion in 2023 and is expected to reach USD 11.14 billion by 2031, growing at a CAGR of 37% from 2024 to 2031. This significant growth is driven by the increasing prevalence of schizophrenia, rising awareness about mental health, and advancements in treatment protocols[4].

Key Players and Revenue

Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, holds a significant share of the market due to its innovative formulations and extensive research and development history. Janssen has reported over $3 billion in revenue from its psychotropic drugs, including paliperidone. Other key players like Mylan (now part of Viatris), Teva Pharmaceuticals, and Sun Pharmaceutical also generate substantial revenues from their generic and branded offerings[3].

Emerging Trends

Telemedicine Integration

The integration of telemedicine services has made prescribing paliperidone more accessible, enhancing patient adherence and treatment outcomes. This trend is expected to continue, driven by the convenience and accessibility it offers[3].

Long-Acting Injectable Formulations

Innovations in sustained-release formulations, including long-acting injectable forms, are improving patient compliance. These formulations reduce the frequency of dosing, making treatment more manageable for patients[3].

Personalized Medicine

Advances in genomic profiling are allowing for tailored treatment plans, enhancing the efficacy of paliperidone for individual patients. This personalized approach is expected to drive further growth in the market[3].

Digital Health Tools

The use of mobile apps and wearables for monitoring mental health can improve outcomes in patients using paliperidone. These digital health tools provide real-time data and support, enhancing treatment adherence and effectiveness[3].

Competitive Analysis

The competitive landscape of the paliperidone market is dominated by key players such as Janssen Pharmaceutica, Mylan, Teva, and Sun Pharmaceutical. These companies are focusing on expanding their product offerings, improving access to medications, and investing in research and development to maintain their market share and drive innovation[3].

Future Outlook

The paliperidone market is expected to witness steady growth in the coming years, driven by the increasing prevalence of schizophrenia and other psychotic disorders, the rising demand for effective and safe antipsychotic medications, and the growing awareness about the importance of mental health treatment. The market will also benefit from the development of new and innovative formulations, the increasing demand in emerging markets, and the growing focus on personalized medicine[1].

Key Takeaways

• The paliperidone market is driven by the increasing prevalence of schizophrenia and other psychotic disorders.
• Extended-release tablets are a key segment due to their once-daily formulation and improved patient compliance.
• North America and Europe are significant markets, with the Asia Pacific region expected to show the highest growth rate.
• The market is expected to reach USD 3.2 billion by 2033, with a broader market projection of USD 11.14 billion by 2031.
• Key players include Janssen Pharmaceutica, Mylan, Teva, and Sun Pharmaceutical.
• Emerging trends include telemedicine integration, long-acting injectable formulations, personalized medicine, and digital health tools.

FAQs

Q: What is the primary use of paliperidone?

A: Paliperidone is primarily used to treat schizophrenia, schizoaffective disorder, and other mental health conditions.

Q: What is driving the growth of the paliperidone market?

A: The growth is driven by the increasing prevalence of schizophrenia, rising awareness about mental health, and advancements in treatment protocols.

Q: Which region is expected to witness the highest growth rate in the paliperidone market?

A: The Asia Pacific region is expected to witness the highest growth rate due to increasing prevalence of mental health disorders and growing awareness about mental health treatment.

Q: Who are the key players in the paliperidone market?

A: Key players include Janssen Pharmaceutica, Mylan, Teva, and Sun Pharmaceutical.

Q: What are some emerging trends in the paliperidone market?

A: Emerging trends include telemedicine integration, long-acting injectable formulations, personalized medicine, and the use of digital health tools.

Sources

1. DataHorizon Research: Paliperidone Extended Release Tablets Market Size, Share, Growth...
2. Johnson & Johnson: Q3 2021 Press Release with Attachments
3. OpenPR: Paliperidone Market Overview: Segmentation Analysis, Growth Trends and Forecast
4. Market Research Intellect: Paliperidone Market Size, Share | Growth Report, 2031