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 three patents protecting this drug.

This drug has forty-eight patent family members in nineteen 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^® Litigation and Generic Entry Outlook for Invega Hafyera

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

Summary for INVEGA HAFYERA

International Patents:	48
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	139
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

Pharmacology for INVEGA HAFYERA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for INVEGA HAFYERA

INVEGA HAFYERA is protected by three US patents and one FDA Regulatory Exclusivity.

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
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No

International Patents for INVEGA HAFYERA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4025188	SCHÉMAS POSOLOGIQUES ASSOCIÉS À DES FORMULATIONS INJECTABLES DE PALIPÉRIDONE À LIBÉRATION PROLONGÉE (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2022112367
Eurasian Patent Organization	201792209	СХЕМА ВВЕДЕНИЯ ПРОПУЩЕННЫХ ДОЗ ИНЪЕКЦИОННЫХ СЛОЖНЫХ ЭФИРОВ ПАЛИПЕРИДОНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ
World Intellectual Property Organization (WIPO)	2022111859

Supplementary Protection Certificates for INVEGA HAFYERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	91842	Luxembourg		91842, EXPIRES: 20220512
0904081	416	Finland
0904081	PA2011008	Lithuania		PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 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

INVEGA HAFYERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVEGA HAFYERA

Introduction

INVEGA HAFYERA, a long-acting injectable atypical antipsychotic, is part of the INVEGA family of products developed by Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson. This medication is used for the treatment of schizophrenia in adults. Here, we will delve into the market dynamics and financial trajectory of INVEGA HAFYERA, highlighting key trends, challenges, and financial performance.

Market Context

The market for antipsychotic medications is highly competitive and influenced by various factors, including regulatory changes, patent expirations, and the introduction of new therapies.

Competitive Landscape

The antipsychotic market includes a range of products from various pharmaceutical companies. INVEGA HAFYERA competes with other long-acting injectable antipsychotics as well as oral formulations. The competitive landscape is dynamic, with companies like Alkermes, Eli Lilly, and AstraZeneca also having significant presence in the psychiatric treatment market[4].

Regulatory Environment

Regulatory changes can significantly impact the market dynamics of pharmaceutical products. For instance, the partial termination of the license agreement between Janssen and Alkermes for the long-acting INVEGA products in the U.S. had a notable impact on royalty revenues[1].

Financial Performance

Revenue Trends

The financial performance of INVEGA HAFYERA is closely tied to the overall sales of the INVEGA product family. In the first quarter of 2023, royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, and INVEGA HAFYERA were $13.6 million, significantly lower than the $37.1 million in the same period of the prior year. This decrease was primarily due to the partial termination of the license agreement with Alkermes[1].

However, in the second quarter of 2023, there was a significant rebound in royalty revenues. The company recorded $321.2 million in royalty revenues, which included back royalties and associated interest related to U.S. net sales of these products in 2022 and the first quarter of 2023[2].

Impact of License Agreement Changes

The partial termination of the license agreement with Alkermes in February 2022 had a substantial impact on the financial performance of INVEGA HAFYERA. This change led to a temporary decline in royalty revenues but was later mitigated by the reinstatement of royalties and the inclusion of back payments[1][2].

Market Growth and Projections

Sales Growth

Despite the challenges posed by the license agreement changes, the INVEGA product family has shown resilience. The reinstatement of royalties in the second quarter of 2023 reflected solid execution across the portfolio, highlighting the strong market demand for these products[2].

Future Outlook

Johnson & Johnson projects robust growth in the pharmaceutical sector, driven by its portfolio and pipeline. The company expects a compound annual growth rate (CAGR) of 5-7% from 2025 to 2030, with significant contributions from its key brands, including the INVEGA family[3].

Challenges and Opportunities

Patent Expirations and Generic Competition

One of the significant challenges facing INVEGA HAFYERA is the potential for generic competition following patent expirations. However, the long-acting injectable formulation provides a barrier to entry for generics, potentially extending the product's market exclusivity[4].

Market Expansion

There are opportunities for market expansion through increased penetration in existing markets and entry into new geographic regions. The growing awareness and treatment rates for schizophrenia and other psychiatric disorders also present a positive outlook for INVEGA HAFYERA[4].

Impact of Economic Factors

Economic Fluctuations

Economic factors such as interest rate and currency exchange rate fluctuations can impact the financial performance of pharmaceutical companies. However, the demand for essential medications like INVEGA HAFYERA tends to be less elastic, providing a degree of stability[3].

Conclusion

The market dynamics and financial trajectory of INVEGA HAFYERA are influenced by a combination of regulatory, competitive, and economic factors. Despite the challenges posed by license agreement changes, the product has shown strong market demand and is expected to contribute significantly to Johnson & Johnson's growth projections.

Key Takeaways

• Regulatory Impact: Changes in license agreements can significantly affect royalty revenues.
• Market Resilience: The INVEGA product family has shown strong market demand despite regulatory challenges.
• Future Growth: Johnson & Johnson projects robust growth driven by its portfolio, including the INVEGA family.
• Challenges and Opportunities: Patent expirations and generic competition pose challenges, but market expansion opportunities exist.
• Economic Stability: Demand for essential medications like INVEGA HAFYERA remains relatively stable despite economic fluctuations.

FAQs

Q: What is INVEGA HAFYERA used for?

A: INVEGA HAFYERA is a long-acting injectable atypical antipsychotic used for the treatment of schizophrenia in adults.

Q: How did the license agreement change affect INVEGA HAFYERA's financial performance?

A: The partial termination of the license agreement led to a temporary decline in royalty revenues but was later mitigated by the reinstatement of royalties and back payments.

Q: What are the future growth projections for INVEGA HAFYERA?

A: Johnson & Johnson expects a CAGR of 5-7% from 2025 to 2030, with significant contributions from the INVEGA family.

Q: What challenges does INVEGA HAFYERA face in the market?

A: The product faces challenges such as patent expirations and potential generic competition, as well as economic fluctuations.

Q: How does economic instability affect the demand for INVEGA HAFYERA?

A: The demand for essential medications like INVEGA HAFYERA tends to be less elastic, providing a degree of stability despite economic fluctuations.

Sources

1. Alkermes plc Reports First Quarter 2023 Financial Results - Alkermes Investor Relations
2. Alkermes plc Reports Second Quarter 2023 Financial Results - Alkermes Investor Relations
3. Innovative Medicine Presentation Update - Johnson & Johnson
4. FOR IMMEDIATE RELEASE: Johnson & Johnson Reports 2021 Third-Quarter Results - Johnson & Johnson