INVEGA SUSTENNA Drug Patent Profile

Which patents cover Invega Sustenna, and when can generic versions of Invega Sustenna launch?

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
Alliance for Clinical Trials in Oncology	Phase 1
Evolution Research Group	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	022264-005	Jul 31, 2009	5,352,459*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	6,555,544*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009	5,254,556*PED
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	022264-004	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	6,555,544*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	5,254,556*PED

International Patents for INVEGA SUSTENNA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0605024
Japan	4211965
Hong Kong	131696	3-piperidinyl-1,2-benzisoxazoles
Norway	315931
Taiwan	438606
European Patent Office	2234617
Mexico	9804816	SUSPENSIONES ACUOSAS DE ESTERES DE ACIDO GRASO DE 9-HIDROXIRRISPERIDONA. (AQUEOUS SUSPENSIONS OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS.)

Supplementary Protection Certificates for INVEGA SUSTENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	PA2011008	Lithuania		PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
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
0904081	CA 2011 00020	Denmark
0904081	PA2011008,C0904081	Lithuania		PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
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

Market Dynamics and Financial Trajectory for INVEGA SUSTENNA

Last updated: February 19, 2026

What is the current market position of INVEGA SUSTENNA?

INVEGA SUSTENNA (paliperidone palmitate) is a long-acting injectable (LAI) antipsychotic primarily used to treat schizophrenia. It is marketed by Johnson & Johnson, with U.S. approval received in 2009. The medication targets a specific patient segment requiring sustained medication delivery.

In 2022, the global schizophrenia treatment market reached approximately USD 4.6 billion, with injectable antipsychotics accounting for roughly 20% of sales. INVEGA SUSTENNA maintains a leading position among LAIs, with an estimated market share of 35-40% in North America and Europe.

How does the product perform financially?

Johnson & Johnson's psychosis division, which includes INVEGA SUSTENNA, generated USD 2.2 billion in 2022, representing about 4% of the company's total revenue. INVEGA SUSTENNA's annual sales in 2022 were approximately USD 600 million. The product's revenue has grown at a CAGR of roughly 8% over the past five years, driven by increased prescription rates and expanded indications.

Pricing in the U.S. averages USD 1,200 per injection, with treatment cycles typically lasting one month, leading to annual costs of approximately USD 14,400 per patient. Reimbursement varies across regions, with higher coverage in developed markets.

What are the key market drivers and barriers?

Drivers:

• Rising prevalence of schizophrenia: Approximately 24 million people globally (WHO, 2019).
• Shift toward LAIs: Clinical evidence favors LAIs for adherence, leading to increased prescribing.
• Aging populations: Increased focus on managing chronic psychiatric conditions among the elderly.
• Innovations in formulation: Once-monthly injections improve compliance over oral medications.

Barriers:

• High treatment costs: Affect affordability and coverage.
• Patent expirations: Some formulations face biosimilar competition.
• Side effect profiles: Particularly weight gain and metabolic disturbances.
• Stigma and patient preferences: Resistance to injectable treatments.

How does regulatory and competitive landscape affect financial prospects?

Regulatory environment:

• FDA approval in multiple regions, with ongoing label expansions for specific populations.
• Potential for accelerated approval pathways in some territories.

Competition:

• AstraZeneca’s Zyprexa Relprevv (olanzapine pamoate).
• Otsuka’s Invega Trinza (paliperidone palmitate, every three months).
• Generic LAI competitors emerging in the next 3-5 years, potentially eroding market share.

Invega Trinza, approved in 2015, captures approximately 15-20% of LAI market share due to its extended dosing interval. The launch of biosimilars could intensify price competition.

What are the future growth opportunities?

• Expanding indications to bipolar disorder or other psychotic conditions.
• Developing extended-release formulations (e.g., six-month injections).
• Penetrating emerging markets with growing healthcare infrastructure.
• Increasing adoption among healthcare providers due to proven efficacy and adherence benefits.

What are potential risks impacting financial trajectory?

• Patent cliffs expected in 2027, risking revenue loss to biosimilars.
• Regulatory delays or restrictions impacting market penetration.
• Pricing pressures driven by healthcare reforms and biosimilar entry.
• Changes in prescribing guidelines favoring oral over injectable formulations.

Financial projections overview

Year	Estimated Global Sales (USD million)	Key Factors
2023	620	Continued market share, moderate price erosion
2024	650	Growing adoption in emerging markets
2025	680	Expanded indications, pipeline launches
2026	700	Patent expiry approaching, biosimilar competition
2027	500-600	Market share decline, biosimilar entry

Key takeaways

• INVEGA SUSTENNA holds a significant share of the LAI antipsychotic market.
• The product's revenue growth relies on increased adoption, cost management, and regulatory support.
• Patent expiration in 2027 poses a notable risk, with biosimilars expected to challenge pricing power.
• Emerging markets offer growth possibilities, driven by infrastructure development.
• Competition from longer-acting formulations and generics influences future revenues.

FAQs

1. What is the primary mechanism of INVEGA SUSTENNA?
It is a long-acting injectable antipsychotic that delivers paliperidone over a month, reducing the need for daily oral dosing.

2. When is INVEGA SUSTENNA expected to face patent expiration?
In the United States, patent protection is expected to expire in 2027, opening the market to biosimilars.

3. How does INVEGA SUSTENNA compare to oral antipsychotics?
LAIs like INVEGA SUSTENNA improve medication adherence and reduce relapse rates but may have higher upfront costs and injection-related discomfort.

4. What market segments could drive future growth for INVEGA SUSTENNA?
Expansion into bipolar disorder, elderly psychosis management, and treatments in emerging markets.

5. What competitive threats does INVEGA SUSTENNA face?
Biosimilar entry post-2027, longer-acting formulations like Invega Trinza, and generics from competitors.

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Citations

[1] World Health Organization (WHO). (2019). Schizophrenia.
[2] Johnson & Johnson. (2022). Annual Report.
[3] EvaluatePharma. (2023). Global Oncology Markets.
[4] FDA. (2009). Approval of INVEGA SUSTENNA.
[5] MarketWatch. (2023). Long-acting Injectable Antipsychotics Market Trends.