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 five 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^® Litigation and Generic Entry Outlook for Invega

A generic version of INVEGA was approved as paliperidone palmitate by TEVA PHARMS USA on July 6^th, 2021.

Summary for INVEGA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	29
Patent Applications:	1,840
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
Alliance for Clinical Trials in Oncology	Phase 1
Evolution Research Group	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	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	AB	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	021999-006	Aug 26, 2008
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	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/005486 Byannli (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/004066 Trevicta, 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/002105 Xeplion 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

International Patents for INVEGA

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

Country	Patent Number	Title	Estimated Expiration
Israel	92208
Norway	894411
Denmark	169923

Supplementary Protection Certificates for INVEGA

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	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304

INVEGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of INVEGA

Introduction to INVEGA

INVEGA, developed by Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson, is a significant player in the treatment of schizophrenia and other psychiatric disorders. The drug is available in several formulations, including INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA, all of which are long-acting injectable antipsychotics.

Clinical Efficacy and Market Position

Reducing Hospitalizations and Improving Adherence

Studies have shown that INVEGA SUSTENNA is associated with significant reductions in psychiatric hospitalizations and emergency room visits compared to oral antipsychotics (OAPs)[3]. This efficacy translates into higher patient adherence rates, which is crucial for the effective management of schizophrenia.

Market Demand

INVEGA SUSTENNA has established itself as a leading treatment option for schizophrenia, driven by its clinical benefits and the growing need for effective antipsychotic treatments. The global antipsychotic drugs market, valued at USD 16.88 billion in 2023, is projected to grow at a CAGR of 6.1% from 2024 to 2030, with second-generation antipsychotics like INVEGA dominating the market[1].

Financial Performance

Sales and Revenue Growth

The financial performance of INVEGA is closely tied to its sales and royalty revenues. In the third quarter of 2021, Johnson & Johnson reported a 13.8% growth in pharmaceutical operational sales, driven in part by INVEGA SUSTENNA[3].

Alkermes plc, which receives royalty revenues from INVEGA products, reported significant increases in these revenues. For instance, in the second quarter of 2023, royalty revenues from INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA were $321.2 million, including back royalties and associated interest[2][5].

Royalty Revenues

Royalty revenues from INVEGA products have seen fluctuations due to changes in license agreements. In the first quarter of 2022, Alkermes plc reported a 31% increase in royalty revenues from INVEGA SUSTENNA and related products. However, by the first quarter of 2023, these revenues decreased due to the partial termination of the license agreement by Janssen effective February 2, 2022[3][5].

Cost and Pricing Dynamics

Average Retail Cost

The average retail cost of INVEGA SUSTENNA is approximately $4,089 as of December 2024, though this can vary based on the prescribed dosage and other factors[3].

Geographical and Pharmacy Variations

The cost of INVEGA SUSTENNA can differ across regions and pharmacies due to local economic conditions and healthcare market dynamics. Health insurance coverage also plays a significant role in reducing out-of-pocket costs for patients[3].

Healthcare Resource Utilization and Cost Outcomes

Reduced Hospitalizations and Emergency Room Visits

Studies have shown that patients treated with INVEGA SUSTENNA have fewer psychiatric hospitalizations and emergency room visits, leading to lower medical costs. While the pharmacy costs for INVEGA SUSTENNA are higher, these are often offset by lower medical costs, resulting in similar or reduced total healthcare costs compared to oral antipsychotics[3].

Total Healthcare Costs

The overall healthcare costs for patients on INVEGA SUSTENNA can be similar or even lower than those on oral antipsychotics due to the reduction in hospitalizations and emergency room visits. For instance, patients treated with INVEGA SUSTENNA had lower all-cause per-patient-per-year (PPPY) medical costs, with a mean cost difference of -$6,273 compared to those treated with oral antipsychotics[3].

Market Challenges and Opportunities

Competition

The antipsychotic market is highly competitive, with other long-acting injectable (LAI) antipsychotics and oral medications vying for market share. Changes in license agreements, such as the partial termination by Janssen, can also impact royalty revenues and overall financial performance[3].

Expanding Indications

Potential expansion into new treatment indications could provide growth opportunities for INVEGA SUSTENNA. For example, the approval of INVEGA HAFYERA as the first-and-only twice-yearly injectable for treating schizophrenia in adults opens up new avenues for market growth[4].

Expert Insights

Industry experts emphasize the importance of long-acting antipsychotics like INVEGA SUSTENNA in managing schizophrenia.

"Long-acting injectable antipsychotics like INVEGA SUSTENNA are crucial for improving adherence and reducing hospitalizations in patients with schizophrenia," said a leading psychiatrist[3].

Illustrative Statistics

• Revenue Growth: In 2021, the pharmaceutical segment of Johnson & Johnson, which includes INVEGA SUSTENNA, saw a 13.8% growth in operational sales[3].
• Cost Savings: Patients treated with INVEGA SUSTENNA had lower all-cause per-patient-per-year (PPPY) medical costs, with a mean cost difference of -$6,273 compared to those treated with oral antipsychotics[3].

Regional Market Dynamics

North America

North America dominated the antipsychotic drugs market with a revenue share of 37.67% in 2023. The strong prevalence of psychiatric illnesses in the region, along with the presence of prominent biopharmaceutical companies, drives this market dominance. For instance, approximately 57.8 million individuals in the U.S. had a mental illness in 2021, contributing to the high demand for antipsychotics in the region[1].

Future Trends and Growth

Increased Adoption of Long-Acting Injectables

The market is expected to grow due to the increased adoption and launch of long-acting injectable antipsychotics. For example, Paliperidone (INVEGA TRINZA and INVEGA HAFYERA) comes in a newer long-acting injectable formula, requiring patients to take this injection only four times a year, which improves treatment outcomes and drives market growth[4].

Technological Superiority

The third generation of antipsychotics, which includes advanced products like those in the INVEGA family, is anticipated to account for the highest CAGR in the forecast period. This growth is driven by new product launches and a greater degree of technological superiority over other drug classes[4].

Online Pharmacies

The transition towards online pharmacies is expected to boost the segment’s growth, ensuring increased patient convenience and ease in medication procurement[4].

"The increasing demand for these therapeutics, growing awareness regarding mental illnesses, and the increasing engagement of prominent companies in R&D initiatives leading to new product launches are factors driving the product adoption exponentially." - Market Report[4]

Key Takeaways

• Clinical Efficacy: INVEGA SUSTENNA and related products have demonstrated strong clinical efficacy in reducing hospitalizations and improving patient adherence.
• Financial Performance: The financial trajectory is influenced by sales and royalty revenues, with significant growth seen in recent years but also impacted by changes in license agreements.
• Cost Dynamics: The cost of INVEGA SUSTENNA varies based on dosage, location, and insurance coverage, but it can lead to significant cost savings in healthcare resource utilization.
• Market Challenges: The market faces competition and challenges from changes in license agreements but also has opportunities for growth through expanding indications and technological advancements.
• Regional Dominance: North America dominates the market due to high prevalence of psychiatric illnesses and the presence of major biopharmaceutical companies.

FAQs

What is INVEGA SUSTENNA used for?

INVEGA SUSTENNA is a long-acting injectable antipsychotic medication used primarily for the treatment of schizophrenia and other psychiatric disorders.

How does INVEGA SUSTENNA impact hospitalizations?

INVEGA SUSTENNA has been shown to significantly reduce psychiatric hospitalizations and emergency room visits compared to oral antipsychotics, leading to lower medical costs.

What are the key factors driving the growth of the INVEGA market?

The growth is driven by the increasing demand for effective antipsychotic treatments, growing awareness of mental illnesses, and the engagement of prominent companies in R&D initiatives leading to new product launches.

How does the cost of INVEGA SUSTENNA vary?

The cost of INVEGA SUSTENNA varies based on the prescribed dosage, geographical location, and health insurance coverage.

What are the future trends in the antipsychotic drugs market?

The market is expected to grow due to the increased adoption of long-acting injectable antipsychotics, technological superiority of new products, and the transition towards online pharmacies.

Sources

1. Grand View Research - Antipsychotic Drugs Market Size And Share Report, 2030
2. PR Newswire - Alkermes plc Reports Second Quarter 2023 Financial Results
3. Drug Patent Watch - INVEGA SUSTENNA Drug Patent Profile
4. Fortune Business Insights - Antipsychotic Drugs Market Size, Share | Growth [2024-2032]
5. Alkermes Investor Relations - Alkermes plc Reports Second Quarter 2023 Financial Results