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-five 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:	75
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	No	11,324,751
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	11,304,951
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	12,208,100
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	11,304,951
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	12,208,100
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	11,324,751
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	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
Hungary	E065573
Estonia	9800136
Poland	327995
Japan	2018510894	長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン
European Patent Office	4385564
Denmark	0904081
Mexico	2024009188	REGIMENES DE DOSIFICACION ASOCIADOS CON FORMULACIONES INYECTABLES DE PALIPERIDONA DE LIBERACION PROLONGADA. (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS.)

Supplementary Protection Certificates for INVEGA HAFYERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	91842	Luxembourg		91842, EXPIRES: 20220512
0904081	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 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	C00904081/01	Switzerland		PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
0904081	416	Finland
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
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 HAFYERA

Last updated: July 27, 2025

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Introduction

INVEGA HAFYERA, developed by Janssen Pharmaceuticals, is a long-acting injectable formulation of paliperidone designed for the treatment of schizophrenia and schizoaffective disorder. Approved by the Food and Drug Administration (FDA) in 2021, it represents a significant advancement in antipsychotic therapy, offering a quarterly dosing option aimed at improving adherence and patient outcomes. As a novel product in the psychiatric therapeutics space, INVEGA HAFYERA's market dynamics and financial trajectory are influenced by multiple factors, including clinical efficacy, competitive landscape, regulatory policies, and evolving healthcare paradigms.

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Market Overview

The global schizophrenia therapeutics market was valued at approximately USD 9 billion in 2021, with sustained growth projected through 2030 driven by increased prevalence, destigmatization, and innovative drug development [1]. Schizoaffective disorder, while less prevalent, compounds market size due to the complexity of management. The long-acting injectable (LAI) segment has gained momentum, contributing roughly 30% to the overall antipsychotic market share, owing to improved adherence and reduced relapse rates [2].

INVEGA HAFYERA’s entry into this segment positions it as a preferred option for clinicians seeking quarterly injection schedules, particularly for patients with poor medication adherence. The drug's unique extended-release profile distinguishes it distinctly among existing LAIs such as Johnson & Johnson’s RISPERDAL CONSTA, or Otsuka’s ABILIFY MAINTENA.

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Market Dynamics

Clinical and Therapeutic Drivers

The principal driver behind INVEGA HAFYERA’s market potential hinges on its pharmacokinetic profile. Quarterly dosing reduces the treatment burden and improves patient compliance compared to daily oral medications or other LAIs requiring more frequent administration [3]. Clinical trials have demonstrated that HAFYERA effectively maintains therapeutic plasma concentrations, reduces relapse rates, and improves functional outcomes, bolstering clinician confidence.

Moreover, evolving guidelines, such as those from the American Psychiatric Association (APA), increasingly recommend LAIs for early or relapse-prone schizophrenia patients, broadening the target demographic [4]. This paradigm shift favors drugs like INVEGA HAFYERA, especially when paired with shared decision-making and personalized medicine approaches.

Competitive Landscape

The competitive environment for INVEGA HAFYERA is intense. Established LAIs, including RISPERDAL CONSTA, ZYPREXA RELPREVV, and ABILIFY MAINTENA, have entrenched market positions. However, the quarterly dosing schedule of HAFYERA and its approval as a closely integrated formulation (co-prescribed with INVEGA SUSTENNA) provide differentiating benefits.

Furthermore, upcoming therapies, such as long-acting formulations employing novel drug delivery platforms—nanotechnology, gene-based approaches—may challenge existing players. The presence of biosimilars, potential patent expirations, and regulatory pathways for generics also influence market pressures, potentially impacting pricing strategies.

Regulatory and Reimbursement Factors

Regulatory approvals worldwide affect the drug's market access. Since INVEGA HAFYERA is approved in the U.S., Europe, and other developed jurisdictions, reimbursement policies significantly influence adoption. Managed care has begun favoring LAIs due to their cost-effectiveness linked to reduced hospitalization and relapse costs.

Pricing strategies are pivotal; given the high costs characteristic of LAIs, payers are scrutinizing value propositions. Demonstrating improved adherence, reduced relapse-related hospitalization, and long-term cost savings is crucial for reimbursement negotiations [5].

Market Penetration and Adoption

Initial launch phases indicate cautious but steady uptake, primarily driven by specialist psychiatrists and academic institutions. Over time, increased awareness—bolstered by clinical guidelines, education campaigns, and real-world evidence—will likely expand prescribing.

The COVID-19 pandemic impacted early distribution, but telepsychiatry and remote monitoring innovations have mitigated some barriers. The drug's unique quarterly schedule makes it a strategic choice for outpatient settings prioritizing minimal visits.

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Financial Trajectory

Revenue Projections

Forecasts suggest that INVEGA HAFYERA will contribute incremental revenue growth within the broader schizophrenia market. Analysts predict a compound annual growth rate (CAGR) of approximately 12-15% over the next five years, driven by increased adoption and expanding indications [6].

Estimates place its global sales potential in the range of USD 1-2 billion by 2030, contingent on market penetration rates and competitive developments. A critical success factor remains the drug’s ability to carve out a sizable share in both developed and emerging markets.

Pricing and Reimbursement Dynamics

Pricing strategies will heavily influence revenue. Currently, LAIs command premium pricing owing to convenience and adherence benefits. Janssen’s pricing likely aligns with competing LAIs, with negotiated discounts and formulary placements affecting net revenue.

Reimbursement policies favoring cost-effective treatments, especially in healthcare systems striving to reduce hospitalizations, reinforce the financial prospects. Cost-effectiveness analyses highlighting decreased hospitalization rates and improved quality-adjusted life years (QALYs) will promote favorable formulary listing.

Market Fragmentation and Growth Opportunities

Emerging markets present substantial growth opportunities, especially where healthcare infrastructure improves rapidly and mental health awareness increases. However, regulatory challenges and pricing constraints may temper short-term expansion.

Continued innovation, such as combination therapies or new delivery platforms, could open ancillary revenue streams, boosting the overall financial trajectory.

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Challenges and Risks

Key risks for INVEGA HAFYERA include:

• Competitive Innovations: Advances in oral or alternative delivery methods could diminish market share.
• Pricing Pressures: Payers demanding price reductions and increased utilization of generics may erode margins.
• Regulatory Hurdles: Delays or restrictions could impair market access.
• Reimbursement Landscape Shifts: Budget cuts or policy changes favoring lesser-cost alternatives could impact profitability.
• Clinical Adoption: Slow uptake due to clinician reluctance or patient preferences for other formulations might limit revenue.

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Conclusion

INVEGA HAFYERA’s market dynamics are shaped by its clinical advantages, evolving treatment guidelines, and a competitive landscape dominated by entrenched LAIs. Its financial trajectory appears promising, with forecasted growth driven by increasing adoption, favorable reimbursement, and expanding indications. However, aggressive competition and regulatory challenges necessitate strategic positioning. Continuous real-world evidence generation and market education will be pivotal to maximize its commercial potential.

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Key Takeaways

• INVEGA HAFYERA offers a quarterly, long-acting injectable option that enhances adherence in schizophrenia treatment, a key market driver.
• The global schizophrenia therapeutics market is growing, with LAIs gaining acceptance due to their clinical benefits.
• Competitive landscape includes established LAIs, but differentiators like dosing schedule and combination prescribing may favor INVEGA HAFYERA.
• Revenue potential is substantial, with forecasted CAGR of approximately 12-15%; success depends on market penetration and payer dynamics.
• Risks include competitive innovation, pricing pressures, and regulatory hurdles; proactive strategies are essential for sustained growth.

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FAQs

1. What distinguishes INVEGA HAFYERA from other LAI antipsychotics?
It provides quarterly dosing, reducing treatment burden and improving adherence, which is not available with most LAIs that typically require biweekly or monthly administration.

2. What patient populations are most likely to benefit from INVEGA HAFYERA?
Patients with schizophrenia or schizoaffective disorder who have challenges maintaining medication adherence, especially those with previous relapses or non-compliance.

3. How does reimbursement landscape impact INVEGA HAFYERA’s sales?
Reimbursement policies favoring cost-effective treatments and reduced hospitalizations enhance market access, whereas restrictive formularies or high out-of-pocket costs may limit usage.

4. Which competitors pose the greatest threat to INVEGA HAFYERA?
Established LAIs like RISPERDAL CONSTA, ABILIFY MAINTENA, and upcoming innovative formulations could challenge market share, especially if they introduce similar dosing schedules or improved delivery systems.

5. What strategies can Janssen adopt to maximize INVEGA HAFYERA’s market potential?
Investing in real-world evidence, expanding global access, engaging with clinicians through education, and demonstrating cost savings will be key to increasing adoption and revenues.

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References

[1] Grand View Research. "Schizophrenia Drugs Market Size, Share & Trends Analysis Report." 2022.
[2] Clinical Therapeutics. "Long-acting injectable antipsychotics: An overview." 2021.
[3] European Psychiatric Association. "Guidelines on Pharmacotherapy for Schizophrenia." 2020.
[4] American Psychiatric Association. "Practice Guidelines for the Treatment of Patients with Schizophrenia." 2021.
[5] IQVIA. "Global Market Trends in Antipsychotics." 2022.
[6] EvaluatePharma. "Long-acting Injectable Antipsychotics Forecast." 2022.