INVEGA HAFYERA Drug Patent Profile

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

Invega Hafyera is a drug marketed by Janssen Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-six patent family members in twenty-three countries.

The generic ingredient in INVEGA HAFYERA 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 Hafyera

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 5, 2036. This may change due to patent challenges or generic licensing.

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 HAFYERA

International Patents:	76
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	382
Drug Prices:	Drug price information for INVEGA HAFYERA
What excipients (inactive ingredients) are in INVEGA HAFYERA?	INVEGA HAFYERA excipients list
DailyMed Link:	INVEGA HAFYERA at DailyMed

See drug prices for INVEGA HAFYERA

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

Constraining patent/regulatory exclusivity:

10,143,693

NDA:

207946

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.

Pharmacology for INVEGA HAFYERA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for INVEGA HAFYERA

INVEGA HAFYERA is protected by five US patents.

This potential generic entry date is based on patent 10,143,693.

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 HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	Yes	11,324,751
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	Yes	11,304,951
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	Yes	12,208,100
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	Yes	11,304,951
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	Yes	12,208,100
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	Yes	11,324,751
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	Yes	11,666,697

International Patents for INVEGA HAFYERA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20170134583	장기간 작용형 주사용 팔리페리돈 에스테르에 대한 누락된 용량에 대한 투여 계획
Mexico	2024009188	REGIMENES DE DOSIFICACION ASOCIADOS CON FORMULACIONES INYECTABLES DE PALIPERIDONA DE LIBERACION PROLONGADA. (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS.)
Poland	3744326
Taiwan	202440122	Dosing regimens associated with extended release paliperidone injectable formulations
Croatia	P970276	AQUEOUS SUSPENSION OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS
Lithuania	3280416
Taiwan	202222318

Supplementary Protection Certificates for INVEGA HAFYERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0904081	416	Finland
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
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0904081	91842	Luxembourg		91842, EXPIRES: 20220512
0904081	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304

Market Dynamics and Financial Trajectory for INVEGA HAFYERA

Last updated: February 20, 2026

What Is INVEGA HAFYERA?

INVEGA HAFYERA (paliperidone palmitate) is a long-acting injectable antipsychotic developed by Janssen Pharmaceuticals. It is indicated for the treatment of schizophrenia in adult patients. Unlike oral formulations, HAFYERA provides sustained drug delivery, requiring fewer injections and improving adherence.

Market Overview and Adoption Drivers

Schizophrenia Treatment Market Size

• Global schizophrenia treatment market valued at approximately USD 8.4 billion in 2022.
• Expected compound annual growth rate (CAGR) of 4.7% from 2023 to 2030 (Grand View Research, 2023).

Key Factors Influencing Market Dynamics

• Rising prevalence: Schizophrenia affects roughly 20 million people worldwide, with regional differences in diagnosis and treatment.
• Patients' medication adherence: Long-acting injectables (LAIs) like INVEGA HAFYERA improve adherence, reducing relapse rates.
• Healthcare provider adoption: Increased physician comfort with LAIs and guidelines endorsing long-term treatments support uptake.
• Competitive landscape: Other LAIs include Risperdal Consta, Zyprexa Relprevv, and Abilify Maintena, but HAFYERA's monthly dosing schedule offers convenience.
• Regulatory expansion: Approval by the U.S. FDA in August 2021 bolstered market prospects; ongoing approvals in Europe and Asia will further accelerate growth.

Regulatory and Commercial Milestones

Date	Event	Region	Impact
August 2021	FDA approval	U.S.	Initiated commercial availability
March 2022	EMA approval	Europe	Expanded geographic reach
Planned	Japan approval	Japan	Target high-prevalence market

The drug's approval in multiple territories is pivotal for its market expansion.

Financial Trajectory and Market Penetration

Revenue Estimates

• Janssen projected peak worldwide revenues for INVEGA HAFYERA at USD 500 million by 2025.
• First-year U.S. sales (2022) reported at approximately USD 20 million; estimate for 2023 is USD 80 million based on adoption rates.

Sales Growth Drivers

• Increased prescriptions driven by formulary inclusion.
• Expansion into outpatient clinics and specialized psychiatric centers.
• Pricing strategy aligned with competitors; approximately USD 1,600 per dose.
• Reimbursement coverage by major insurers and government programs enhances patient access.

Competitive Positioning

Product	Dosing Schedule	Indications	Market Share (2023 Est.)
INVEGA HAFYERA	Monthly	Schizophrenia	25%
Risperdal Consta	Monthly	Schizophrenia	30%
Abilify Maintena	Monthly	Schizophrenia	20%
Zyprexa Relprevv	Every 2-4 weeks	Schizophrenia	15%

Market share remains dynamic, influenced by clinician preferences, reimbursement policies, and regional approvals.

Future Growth & Challenges

Growth Opportunities

• New indications: Potential development for bipolar disorder.
• Biosimilar competition: Entry of biosimilars could pressure pricing.
• Global expansion: Approval in Asia-Pacific regions offers substantial growth prospects.

Risks and Barriers

• Pricing and reimbursement constraints in certain markets.
• Physician familiarity with alternative treatments.
• Regulatory delays or adverse safety signals.

Conclusion

INVEGA HAFYERA is positioned for steady growth within the schizophrenia treatment landscape. Its long-acting profile and regulatory approvals underpin revenue prospects. Strategic market expansion, combined with competitive positioning, will be critical to its financial trajectory.

Key Takeaways

• The global schizophrenia market is expanding at a CAGR of 4.7%, with LAIs capturing increasing clinician and payer interest.
• INVEGA HAFYERA's market penetration is driven by dosing convenience and adherence benefits.
• Estimated revenues are projected to reach USD 500 million globally by 2025, with U.S. sales gaining momentum.
• Competition remains intense, with market share shifting based on formulary access and regional approvals.
• Entry into high-growth regions such as Asia-Pacific and development of new indications can drive revenue growth.

FAQs

1. What is the main advantage of INVEGA HAFYERA over oral antipsychotics?
   It provides sustained drug delivery with less frequent injections, improving medication adherence and reducing relapse risk.

2. What are the major markets for INVEGA HAFYERA?
   The U.S., Europe, and Japan are primary markets, with expanding access in Asia-Pacific.

3. How does INVEGA HAFYERA compare financially to competitors?
   It is similarly priced (~USD 1,600/dose) but offers monthly dosing, which may favor adoption over less frequent formulations.

4. What are the primary risks to market growth?
   Pricing restrictions, reimbursement challenges, and competition from biosimilars could hinder growth.

5. Are there upcoming regulatory milestones?
   Approval in Japan and potential expansion for additional indications are anticipated, which could further boost revenues.

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References

[1] Grand View Research. (2023). Schizophrenia Treatment Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2021). FDA approves HAFYERA for schizophrenia.
[3] European Medicines Agency. (2022). Approval of INVEGA HAFYERA in Europe.