INVEGA SUSTENNA Drug Patent Profile

Which patents cover Invega Sustenna, and what generic alternatives are available?

Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in twenty-nine countries.

The generic ingredient in INVEGA SUSTENNA 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 Sustenna

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 26, 2031. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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 SUSTENNA

International Patents:	38
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	11
Patent Applications:	382
Drug Prices:	Drug price information for INVEGA SUSTENNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVEGA SUSTENNA
What excipients (inactive ingredients) are in INVEGA SUSTENNA?	INVEGA SUSTENNA excipients list
DailyMed Link:	INVEGA SUSTENNA at DailyMed

See drug prices for INVEGA SUSTENNA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INVEGA SUSTENNA

Constraining patent/regulatory exclusivity:

5,254,556

NDA:

022264

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INVEGA SUSTENNA

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 SUSTENNA clinical trials

Pharmacology for INVEGA SUSTENNA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for INVEGA SUSTENNA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVEGA SUSTENNA	Extended-release Injectable Suspension	paliperidone palmitate	39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL	022264	1	2017-11-21

US Patents and Regulatory Information for INVEGA SUSTENNA

INVEGA SUSTENNA is protected by two US patents.

This potential generic entry date is based on patent 5,254,556.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	022264-001	Jul 31, 2009		RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009		RX	Yes	Yes	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009		RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009		RX	Yes	No	9,439,906

Expired US Patents for INVEGA SUSTENNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	5,352,459*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	5,352,459*PED

International Patents for INVEGA SUSTENNA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1029045
Indonesia	16927
African Regional IP Organization (ARIPO)	1228	Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters.
Norway	894411
Ukraine	72189	ВОДНЫЕ СУСПЕНЗИИ СУБМИКРОННОЙ ФОРМЫ ЭФИРОВ 9-ГИДРОКСИРИСПЕРИДОНА ЖИРНЫХ КИСЛОТ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ВОДНУ СУСПЕНЗІЮ СУБМІКРОННИХ ЕФІРІВ 9-ГІДРОКСИРИСПЕРИДОН ЖИРНИХ КИСЛОТ (AQUEOUS SUSPENSIONS OF 9-HYDROXY-RISPERIDONE FATTY ACID ESTERS PROVIDED IN SUBMICRON FORM)
Poland	192203

Supplementary Protection Certificates for INVEGA SUSTENNA

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
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	91362	Luxembourg		91362, EXPIRES: 20141030
0904081	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304

Market Dynamics and Financial Trajectory for INVEGA SUSTENNA

Last updated: December 16, 2025

Executive Summary

INVEGA SUSTENNA (paliperidone palmitate) is an extended-release injectable antipsychotic primarily used in treating schizophrenia and schizoaffective disorder. It has been a significant player in the atypical antipsychotic market since its FDA approval in 2009. This analysis explores the key market drivers, competitive landscape, regulatory influences, sales performance, and future growth potential of INVEGA SUSTENNA, providing a comprehensive view for stakeholders.

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What Are the Key Market Dynamics Influencing INVEGA SUSTENNA?

1. Orphaned and Chronic Disease Market Expansion

Schizophrenia affects approximately 20 million individuals globally, with a higher prevalence in developed markets. Long-acting injectables (LAIs) like INVEGA SUSTENNA are increasingly preferred for their compliance benefits, reducing relapse rates and hospitalization costs.

2. Increasing Demand for LAIs

In 2022, the global LAI antipsychotic market was valued at USD 4.2 billion, projected to grow at a CAGR of 8.1% through 2030 (Grand View Research). INVEGA SUSTENNA commands a significant share owing to its prolonged dosing interval (every 4 weeks) and proven efficacy.

3. Competitive Landscape

Product	Type	Administration Frequency	Market Share (2022)	Key Competitors
INVEGA SUSTENNA	Paliperidone LAI	Monthly	31%	Risperdal Consta (Janssen)
Risperdal Consta	Risperidone LAI	Every 2 weeks	27%	Invega Sustenna
Abilify Maintena	Aripiprazole LAI	Monthly	15%	Other generics
Aristada	Aripiprazole lauroxil	Every 4-8 weeks	10%	Others

(Source: IQVIA, 2022)

4. Formulation and Dosing Advantages

INVEGA SUSTENNA offers flexible dosing options (every 4 weeks), improved tolerability, and reduced side effects compared to oral formulations. These factors contribute to its uptake in clinical practice.

5. Regulatory and Reimbursement Environment

Approval in key markets like the US, EU, and Japan, along with favorable reimbursement policies, enhance market penetration. The FDA's 2010 approval confirmed its safety profile, further driving adoption.

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What Is the Financial Trajectory of INVEGA SUSTENNA?

6. Sales Performance and Revenue Trends

Year	Global Sales (USD Millions)	Year-over-Year Growth	Comments
2015	1,200	—	Launch phase; growing adoption
2018	2,100	+21%	Broader market reach
2020	3,200	+15%	Increased competition but stable growth
2022	3,900	+11.5%	Market saturation in mature regions
2023 (Estimate)	4,200	+7.7%	Expected growth driven by emerging markets

(Data sources: Company financial reports, EvaluatePharma)

7. Revenue Breakdown by Geography

Region	2022 Revenue (USD Millions)	Market Share (%)	Growth Drivers
North America	2,250	58%	High adoption, reimbursement policies
Europe	900	23%	Expanding markets, clinical acceptance
Asia-Pacific	600	15%	Growing mental health awareness, government initiatives
Rest of World	150	4%	Emerging markets, generic competition

(Sources: EvaluatePharma, Company disclosures)

8. Cost Structure and Profitability

R&D expenses for formulation and safety profile improvements: USD 150 million annually (J&J data). While gross margins are approximately 75%, patent expiry timelines impact future profitability.

9. Patent and Generic Challenges

The primary patent protection expired or is nearing expiration in key markets (e.g., US patent expiration in 2028), threatening generic competition that could dilute revenue streams.

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What Are the Market Drivers and Constraints?

10. Drivers

• Clinical Efficacy and Safety Profile: Long-acting injectable forms improve adherence.
• Policy Support: Mental health initiatives and reimbursement coverage promote use.
• Aging Population: Increased prevalence of schizophrenia and related disorders.

11. Constraints

• Generic Competition Post-Patents: Entry of cheaper alternatives post-2028.
• Cost of Injectable Administration: Potential reimbursement restrictions.
• Market Saturation: Especially in developed countries.

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Comparison with Competitors

Parameter	INVEGA SUSTENNA	Risperdal Consta	Aristada	Abilify Maintena
Dosing Interval	4 weeks	2 weeks	4-8 weeks	Monthly
Market Share (2022)	31%	27%	10%	15%
Efficacy	Established	Similar	Similar	Similar
Side Effects	Metabolic, EPS	Mostly metabolic	Metabolic, EPS	Weight changes, akathisia

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What Is the Future Outlook for INVEGA SUSTENNA?

13. Growth Opportunities

• Expanding into Emerging Markets: Regulatory approvals anticipated in Latin America, Southeast Asia.
• Line Extension Development: Longer-acting formulations (e.g., 3-month injectables) are in clinical trials, potentially boosting market share.
• Combination Therapies: Integrating with other mental health treatments.

14. Risks and Uncertainties

• Patent expirations leading to generic erosion.
• Regulatory shifts or pricing pressures.
• Market saturation in mature regions.
• Competition from newer agents with improved profiles.

15. Strategic Actions for Stakeholders

• Pharmaceutical Companies: Invest in pipeline improvements, biosimilars, and geographic expansion.
• Healthcare Providers: Prioritize patient adherence via LAIs.
• Payors & Policy Makers: Support coverage policies for LAIs to reduce overall healthcare expenses.

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Key Takeaways

• INVEGA SUSTENNA remains a dominant injectable antipsychotic with a stable growth trajectory driven by its efficacy, dosing convenience, and evolving clinical guidelines.
• The market is nearing a phase of saturation in developed countries, with substantial growth potential in emerging markets.
• Patent expiry from 2028 onwards poses significant risks of revenue erosion due to generic competition.
• Future growth hinges on geographic expansion, formulation innovations, and strategic positioning against competitors.
• Stakeholders should monitor patent timelines, regulatory policies, and market trends for optimized decision-making.

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FAQs

Q1: When is patent protection expiring for INVEGA SUSTENNA?
A1: The primary composition patent in the US is expected to expire around 2028, opening the field for generic competition.

Q2: How does INVEGA SUSTENNA compare to oral formulations in efficacy?
A2: LAIs like INVEGA SUSTENNA improve medication adherence, reduce relapse rates, and are equally effective when administered properly, with added benefits in compliance.

Q3: What are the main competitors of INVEGA SUSTENNA?
A3: Risperdal Consta, Abilify Maintena, and Aristada are its primary competitors, differing mainly in dosing intervals, efficacy profiles, and market share.

Q4: What regions offer the highest growth potential?
A4: Emerging markets in Asia-Pacific, Latin America, and the Middle East present significant opportunities due to increasing mental health awareness and healthcare infrastructure development.

Q5: How will new formulations affect the market?
A5: Longer-acting injectables (e.g., 3-month formulations) are under clinical development, which could drastically alter market dynamics by offering improved compliance and convenience.

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References

[1] IQVIA. “Global Antipsychotic Market Data,” 2022.
[2] EvaluatePharma. “2022 Sales Data and Market Share,” 2022.
[3] Johnson & Johnson Corporate Reports. “Annual Financials & R&D Expenditure,” 2022.
[4] FDA. “Approval and Safety Profiles for INVEGA SUSTENNA,” 2009.
[5] Grand View Research. “Long-Acting Injectable Antipsychotics Market Forecast,” 2022.