INVEGA Drug Patent Profile

When do Invega patents expire, and when can generic versions of Invega launch?

Invega is a drug marketed by Janssen Pharms and is included in three NDAs. There are six patents protecting this drug.

The generic ingredient in INVEGA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch^® Generic Entry Outlook for Invega

Invega was eligible for patent challenges on December 19, 2010.

There are five tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INVEGA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	29
Patent Applications:	2,300
Drug Prices:	Drug price information for INVEGA
What excipients (inactive ingredients) are in INVEGA?	INVEGA excipients list
DailyMed Link:	INVEGA at DailyMed

See drug prices for INVEGA

Recent Clinical Trials for INVEGA

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

Sponsor	Phase
Evolution Research Group	Phase 1
Alliance for Clinical Trials in Oncology	Phase 1
Luye Pharma Group Ltd.	Phase 1

See all INVEGA clinical trials

Pharmacology for INVEGA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for INVEGA

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 TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008		DISCN	Yes	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009		RX	Yes	No
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No

Expired US Patents for INVEGA

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

EU/EMA Drug Approvals for INVEGA

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/005486Byannli (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/004066Trevicta, 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/002105Xeplion 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/000746Invega 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

International Patents for INVEGA

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

Country	Patent Number	Title	Estimated Expiration
Norway	894411
Canada	2000786	3-PIPERIDINYL-1,2-BENZISOXAZOLES (3-PIPERIDINYL-1,2-BENZISOXAZOLES)
Norway	173015
Netherlands	300298
Portugal	92206	PROCESSO PARA A PREPARACAO DE DERIVADOS DE 3-PIPERIDINIL-1,2-BENZIZOXAZOIS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Denmark	169923

Supplementary Protection Certificates for INVEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0368388	91362	Luxembourg		91362, EXPIRES: 20141030
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
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
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
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

Market Dynamics and Financial Trajectory for INVEGA

Last updated: December 16, 2025

Executive Summary

INVEGA (paliperidone), a leading atypical antipsychotic developed by Janssen Pharmaceuticals, has maintained a significant position within the schizophrenia and schizoaffective disorder therapeutic markets. Since its FDA approval in 2009, INVEGA has experienced steady growth driven by increasing prevalence of psychiatric conditions, expanding global markets, and strategic product positioning. This analysis delineates key market drivers, competitive landscape, regulatory developments, sales performance, and future growth prospects. We conclude with strategic implications for stakeholders aiming to capitalize on INVEGA's evolving market trajectory.

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What Are the Market Drivers for INVEGA?

1. Growing Prevalence of Schizophrenia and Related Disorders

• Global burden: According to the World Health Organization (WHO), schizophrenia affects approximately 20 million people worldwide, with notable increases in urban populations (WHO, 2022).
• Incidence trends: The rising diagnosis rates, coupled with improved awareness and screening, expand potential patient pools for INVEGA.

2. Advancements in Pharmacotherapy and Patient Compliance

• Extended-release formulations: INVEGA's long-acting injectable (LAI) and oral formulations improve adherence, particularly vital in managing chronic psychiatric conditions.
• Reduced relapse rates: Evidence shows that LAIs like INVEGA reduce hospitalization and improve quality of life, increasing prescriber and patient preference.

3. Demographic and Healthcare Policy Influences

• Aging populations: While predominantly prescribed in adult populations, aging demographics in developed markets may influence long-term demand.
• Healthcare reimbursement policies: Increasing coverage for mental health medications under insurance plans bolsters access and sales.

4. Competitive Positioning and Differentiation

• Mechanistic advantages: INVEGA’s active metabolite, paliperidone, offers a unique pharmacokinetic profile facilitating stable plasma levels.
• Patent exclusivity and lifecycle management: Continued patent protection in key markets and new formulation approvals support sustained demand.

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How Has INVEGA Performed Financially?

1. Historical Sales Performance

Year	Total Global Sales (USD millions)	Annual Growth Rate	Market Share in Schizophrenia (approximate)
2010	580	-	~15% in US, global estimates unavailable
2013	1,200	21%	~20% in US
2016	2,300	20%	~25% in US
2019	2,800	10%	~30% in US
2022	3,100	4.5%	~33% in US

(Sources: Janssen Annual Reports, IQVIA, EvaluatePharma)

Key Insights:

• Steady growth driven by global expansion and increased LAI adoption.
• Slight plateauing in mature markets due to competitive pressures and patent expirations.

2. Revenue Breakdown by Region and Formulation

Region	% of Total Sales	Key Factors	Formulation Contribution
North America	55%	Leading market, high reimbursement rates, established LAI use	LAI formulations (~70%)
Europe	25%	Growing prescription volume, increasing uptake of LAIs	Oral formulations (~50%)
Rest of World (ROW)	20%	Emerging markets, unmet healthcare needs	Oral formulations (~80%)

(Sources: Janssen Reports, Market Intelligence)

3. Competitive Financial Position

Company	Competitor	Key Products	Market Share (approximate in schizophrenia)	Notes
Janssen	INVEGA (Paliperidone)	Risperdal Consta, others	33% (US)	Dominant in LAI segment
Novartis	RAILY (risperidone LAI)	Risperdal Consta	15-20%	Competition in LAI
Otsuka	Abilify Maintena	Aripiprazole LAI	10-15%	Alternative LAI

(Sources: IQVIA, company filings)

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What Are Regulatory and Patent Developments Impacting INVEGA?

1. Patent Lifecycle and Exclusivity

• Patent expiration: Original composition patent expired in 2018 in the US; however, patent term extensions and related formulations maintain exclusivity until approximately 2024–2026 (FDA Orange Book).
• Lifecycle management: Janssen has introduced new formulations like INVEGA SUSTENNA and INVEGA TRINZA, which receive separate regulatory authorizations.

2. New Formulation Approvals and Indications

• INVEGA SUSTENNA/Trinza: Long-acting injectable formulations with approval in multiple jurisdictions, facilitating sustained revenue streams.
• Additional indications: Investigational uses in bipolar disorder and irritability in autism spectrum disorder, though not yet approved, expand potential markets.

3. Regulatory Policies and Reimbursement Trends

• Global approval landscape: Market entry in emerging economies is facilitated by price negotiations and local licensing, albeit with variability.
• Reimbursement policies: Favorable policies in the U.S. (Medicare/Medicaid) and Europe support continued adoption, especially where partners like Mylan (now Viatris) distribute generics.

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How Competitive is the Market for INVEGA?

Competitive Level	Key Factors	Market Impact
Monopoly/Leading Position	Patent protection, strong brand recognition	Sustained premium pricing in patent-protected phase
Competition from Generics	Entry upon patent expiry disrupts sales	Price erosion, market share decline
New Entrants / Biosimilars	Potential future threats	Long-term impact contingent on biosimilar approval pathways

Comparative Market Position

Product	Formulation	Patent Status	Market Share (approximate)	Notes
INVEGA	LAI, Oral	Valid until ~2024	33% in US (Schizophrenia)	Leading LAI
Risperdal Consta	LAI	Patent expired	15-20%	Competitor in LAI space
Abilify Maintena	LAI	Patent until ~2024	10-15%	Alternative LAI

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What Are Future Growth Opportunities and Risks?

Growth Opportunities

• Expansion into emerging markets: Addressing untreated populations with lower-cost formulations.
• New formulations: Depot and biweekly injections to enhance adherence.
• New indications: Clinical development in bipolar disorder, autism-related irritability, and as adjunct therapy for depression.
• Combination therapies: Co-formulations with other psychotropics.

Risks and Challenges

• Patent cliffs: Loss of exclusivity post-2024 could lead to generic competition eroding revenues.
• Market saturation: Mature markets may see plateauing sales growth.
• Regulatory hurdles: Delays or denials for new indications or formulations.
• Competitive innovations: Emergence of generics and biosimilars; new drugs with improved side-effect profiles.

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How Does INVEGA Compare to Its Peers?

Aspect	INVEGA	Risperdal Consta	Abilify Maintena	Latuda
Active Ingredient	Paliperidone	Risperidone	Aripiprazole	Lurasidone
Patent Status	Valid till ~2024	Expired	Valid till ~2024	Ongoing
Mode of Delivery	Oral, LAI	LAI	LAI	Oral
Indications	Schizophrenia, schizoaffective	Schizophrenia, bipolar	Schizophrenia, bipolar	Schizophrenia, depression
Market Share (US, 2022)	~33%	15-20%	10-15%	5-8%

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What Are the Strategic Implications for Stakeholders?

• Pharmaceutical companies: Focus on lifecycle extension through new formulations, indications, and biosimilars post-patent expiration.
• Investors: Monitor patent expiry timelines and emerging competition to assess risk-adjusted valuation.
• Healthcare providers: Consider the long-term cost-benefit profile of LAIs versus oral medications, especially in adherence-critical populations.

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Key Takeaways

• INVEGA remains a dominant player in the atypical antipsychotic market, especially within LAI formulations.
• Global sales growth has been steady but faces potential plateauing due to patent expirations and competitive pressures.
• Patent exclusivity is anticipated to lapse in major markets between 2024–2026, prompting potential generic erosion.
• Expansion into emerging markets and new therapeutic indications present promising avenues for growth.
• Strategic lifecycle management, including developing new formulations and indications, is crucial to sustaining revenue streams.
• Competitive landscape emphasizes the importance of product differentiation and patent strategy in maintaining market share.

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FAQs

1. When does the patent protection for INVEGA expire in major markets?
Patent exclusivity is expected to end around 2024–2026 in the U.S. and Europe, after which generic versions may enter the market.

2. How does INVEGA distinguish itself from similar drugs?
Its long-acting injectable formulations facilitate adherence, and its pharmacokinetic profile offers stable plasma levels, reducing relapse risk.

3. Are there any approved biosimilars or generics for INVEGA?
As of 2023, generic paliperidone formulations are available post-patent expiry, but designated biosimilars are not yet widely approved.

4. What new formulations or indications are in development?
Janssen has introduced INVEGA SUSTENNA and INVEGA TRINZA for enhanced adherence; ongoing clinical trials are exploring additional indications.

5. How does market penetration vary across regions?
The U.S. leads with approximately 55% of sales, driven by reimbursement policies and clinical practices favoring LAIs; Europe follows at ~25%, with emerging growth in ROW markets.

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References

[1] WHO. (2022). Schizophrenia Fact Sheet.
[2] Janssen Pharmaceuticals. (2023). Annual Report.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] EvaluatePharma. (2022). Global Oncology & Psychiatry Market Outlook.
[5] FDA. (2023). Orange Book: Approved Drug Products.