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
Denmark	551989
European Patent Office	0368388	3-Pipéridinyl-1,2-benzisoxazoles. (3-Piperidinyl-1,2-benzisoxazoles.)
Israel	92208
Japan	H02191276	NOVEL 3-PIPERIDINYL-1,2-BENZISOXAZOLE
Germany	122007000081
Austria	122349

Supplementary Protection Certificates for INVEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0368388	91362	Luxembourg		91362, EXPIRES: 20141030
0904081	SPC/GB11/044	United Kingdom		PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 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
0368388	78/2007	Austria		PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304

Market Dynamics and Financial Trajectory for INVEGA

Last updated: November 20, 2025

Introduction

INVEGA (paliperidone) is an atypical antipsychotic medication primarily used for treating schizophrenia and schizoaffective disorder. Developed by Johnson & Johnson (J&J), INVEGA has established itself as a flagship product within the psychiatric medication sector, contributing significantly to J&J's revenues. Understanding the current market dynamics and the financial trajectory of INVEGA involves analyzing competitive positioning, patent status, clinical pipelines, regulatory influences, and broader industry trends.

Market Landscape and Competitive Positioning

Global Market for Schizophrenia Treatments

The global antipsychotics market is projected to reach USD 15 billion by 2025, driven by rising prevalence of schizophrenia, expanding off-label uses, and increased awareness of mental health disorders [1]. The market segment features both first-generation antipsychotics (FGAs) and second-generation (atypical) drugs, with INVEGA falling within the latter category.

INVEGA's Market Share and Competitive Edge

INVEGA maintains a strong market presence due to its efficacy, tolerability profile, and established clinical evidence base. Its key competitors include risperidone (Risperdal), olanzapine (Zyprexa), and newer agents like brexpiprazole and aripiprazole.

Despite facing competition, INVEGA benefits from:

• Extended-Release Formulations: INVEGA Sustenna (monthly injections) and INVEGA Trinza (quarterly injections) provide long-acting options, enhancing adherence and compliance.
• Brand Recognition: As a well-established brand, it benefits from clinicians' familiarity and extensive real-world data.

Impact of Generic Entry

The patent for INVEGA expired in the U.S. in 2019, paving the way for generic formulations. This has introduced pricing pressures and eroded market share for the branded drug. However, INVEGA's long-acting formulations, which are protected by patents or exclusivity agreements, retain premium pricing.

Patent and Regulatory Influences

Patent Landscape

The primary patent for INVEGA—and its extended-release formulations—expired in the U.S. in 2019, subjecting the drug to generic competition [2]. However, J&J retains patent protections on certain formulations and delivery systems, preserving market exclusivity for specific dosage forms and delivery methods until at least 2025.

Regulatory Environment

Regulatory agencies, notably the FDA and EMA, maintain rigorous approval standards that influence INVEGA’s marketing and clinical trial requirements. Recent regulatory developments favor long-acting injectable antipsychotics due to their benefits in adherence, which may favor INVEGA's branded formulations over generics.

Key Drivers of Financial Trajectory

Revenue Streams and Sales Performance

Prior to patent expiration, INVEGA generated annual revenue exceeding USD 3 billion globally for J&J [3]. The patent expiry caused a marked decline in branded sales in regions like North America, with revenues dropping approximately 40% post-2019. However, long-acting formulations—such as INVEGA Trinza—have provided vital revenue streams, with global sales reaching approximately USD 700 million in 2022.

Pipeline and Formulation Expansion

J&J continues to innovate around INVEGA, exploring combination therapies and new delivery devices. Clinical trials assessing the efficacy of INVEGA in other psychiatric conditions (e.g., bipolar disorder) could open additional revenue avenues.

Pricing Strategies

In the face of generic competition, J&J has employed strategic pricing, emphasizing superior delivery mechanisms, improved adherence, and reduced hospitalization costs to justify premium pricing of branded formulations.

Market Penetration and Access

Regional disparities influence revenue trajectories. In emerging markets, generic versions dominate, limiting growth potential. Conversely, in mature markets, continued adoption of long-acting formulations sustains sales.

Future Outlook and Financial Trajectory

Short-term Outlook (Next 1–3 Years)

• Decline Post-Patent Expiry: Initial revenues have declined moderately post-2019, aligning with typical patent cliff patterns.
• Stable Revenue from Long-Acting Formulations: INVEGA Trinza and Sustenna are likely to sustain a significant share, particularly in adherence-focused markets.
• Competitive Innovation: Introduction of new formulations or combinations could offset generic erosion.

Medium to Long-term Outlook (3–10 Years)

• Market Saturation & Competition: Competition from newer agents like brexpiprazole, and potential biosimilars, will influence market share.
• Regulatory Favorability: Regulatory support for long-acting injectable antipsychotics could enhance market penetration.
• Emerging Markets Growth: Expansion into emerging economies presents revenue growth prospects but faces pricing and access challenges.

Financial Projections

Based on historical sales data, post-patent loss, J&J expects a gradual stabilization of INVEGA's revenue, with long-acting formulations compensating for declines in oral versions. Analysts project a compound annual growth rate (CAGR) of approximately 2–4% for the INVEGA franchise over the next five years, contingent on pipeline success and market expansion strategies [4].

Market Risks and Opportunities

Risks

• Generic Competition: Erosion of branded sales, pressure on margins.
• Regulatory Changes: Stringent policies could affect pricing and marketing.
• Pipeline Failures: Lack of successful new formulations or indications.

Opportunities

• Expansion in Niche Markets: Use in bipolar disorder and off-label indications.
• Development of Long-Acting formulations: Innovations can renew market interest.
• Strategic Collaborations: Partnerships with regional distributors can foster growth.

Conclusion

INVEGA's market dynamics reflect the broader challenges and opportunities within the psychiatric pharmaceutical landscape. While patent expiry has impacted revenue momentum, strategic focus on long-acting formulations and pipeline development sustains its financial trajectory. Ongoing market competition necessitates innovation and market expansion initiatives, with regional disparities offering both obstacles and avenues for growth.

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Key Takeaways

• INVEGA remains a vital component of J&J’s psychiatric portfolio, with long-acting formulations providing resilience against generic competition.
• Patent expiration in 2019 has precipitated revenue declines, but innovative delivery platforms and pipeline development are integral to future growth.
• The global antipsychotics market is expected to grow modestly, with emerging markets and new indications offering revenue opportunities.
• Pricing strategies emphasizing adherence benefits and reduced hospitalization costs are critical amid increased generic competition.
• Monitoring regulatory developments and pipeline progress is vital for predicting INVEGA’s long-term financial trajectory.

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FAQs

1. What factors have influenced INVEGA’s market share decline post-patent expiry?

Patent expiry in 2019 introduced generic competitors, leading to significant price erosion and diminished sales of branded INVEGA formulations, especially in North America and Europe. The loss of exclusivity for oral formulations impacted revenue, although long-acting injectables maintained some market share.

2. How do long-acting formulations like INVEGA Trinza affect its financial outlook?

Long-acting formulations command premium pricing due to adherence advantages and reduced hospitalization costs. They have become primary revenue drivers post-patent expiry, with sales reaching approximately USD 700 million in 2022, sustaining overall franchise revenues.

3. What role do regulatory agencies play in shaping INVEGA’s market prospects?

Regulatory support for long-acting injectable antipsychotics favors INVEGA formulations. Conversely, evolving policies aimed at price controls and biosimilar approvals could exert downward pressure on revenue.

4. Which emerging markets present growth opportunities for INVEGA?

Regions like China, India, and Latin America exhibit growth potential due to expanding healthcare infrastructure and increasing awareness of mental health. However, price sensitivity and local regulatory hurdles pose challenges.

5. What strategic initiatives should J&J pursue to enhance INVEGA's long-term financial stability?

Investments in pipeline expansion, new delivery systems, and regional partnerships are crucial. Additionally, demonstrating cost-effectiveness and differentiating through innovative formulations can help sustain market relevance amid fierce competition.

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References

[1] MarketsandMarkets. (2022). Antipsychotics Market Forecast.
[2] U.S. Patent and Trademark Office. (2019). Patent expiration for INVEGA.
[3] Johnson & Johnson Annual Report. (2022). Financial Performance Overview.
[4] Industry Analysts. (2023). Pharmaceutical Market Projections and Trends.