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-six patent family members in twenty-seven 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^® Litigation and Generic Entry Outlook for Invega Sustenna

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

Summary for INVEGA SUSTENNA

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	11
Patent Applications:	139
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

Recent Clinical Trials for INVEGA SUSTENNA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Evolution Research Group	Phase 1
Alliance for Clinical Trials in Oncology	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 four US patents.

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	AB	RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	AB	RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	AB	RX	Yes	Yes	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	AB	RX	Yes	No	9,439,906
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	AB	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	022264-004	Jul 31, 2009	5,352,459*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	6,077,843*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	5,352,459*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	0368388	3-Pipéridinyl-1,2-benzisoxazoles. (3-Piperidinyl-1,2-benzisoxazoles.)
Spain	2199481
Norway	981984
Israel	124551	PHARMACEUTICAL DEPOT FORMULATIONS COMPRISING AQUEOUS SUSPENSIONS OF 9-HYDROXY RISPERIDONE FATTY ACID ESTERS
Cyprus	2270	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	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081	C00904081/01	Switzerland		PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
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	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0368388	78/2007	Austria		PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625

INVEGA SUSTENNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVEGA SUSTENNA

Introduction

INVEGA SUSTENNA, a long-acting injectable antipsychotic medication developed by Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson, has been a significant player in the treatment of schizophrenia and other psychiatric disorders. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Position and Demand

INVEGA SUSTENNA has established itself as a leading treatment option for schizophrenia, particularly due to its efficacy in reducing psychiatric hospitalizations and improving medication adherence.

• Clinical Efficacy: Studies have shown that INVEGA SUSTENNA is associated with significant reductions in psychiatric hospitalizations and emergency room visits compared to oral antipsychotics (OAPs)[4].
• Patient Adherence: The medication has been linked to higher adherence rates, which is crucial for the effective management of schizophrenia[4].

Financial Performance

The financial performance of INVEGA SUSTENNA is closely tied to its sales and royalty revenues.

Sales and Revenue Growth

• In the third quarter of 2021, Johnson & Johnson reported that pharmaceutical worldwide operational sales, which include INVEGA SUSTENNA, grew by 13.8% driven by several key products, including DARZALEX, STELARA, and INVEGA SUSTENNA[1].
• Alkermes plc, which receives royalty revenues from INVEGA SUSTENNA, reported a significant increase in these revenues in 2022. However, this trend reversed in 2023 due to changes in the license agreement with Janssen Pharmaceutica N.V.[2][5].

Royalty Revenues

• In the first quarter of 2022, Alkermes plc reported royalty revenues from INVEGA SUSTENNA and related products of $37.1 million, a 31% increase from the same period in the prior year[2].
• However, by the first quarter of 2023, these royalty revenues had decreased to $13.6 million, primarily due to the partial termination of the license agreement by Janssen effective February 2, 2022[5].

Cost and Pricing Dynamics

The cost of INVEGA SUSTENNA is influenced by several factors, including dosage, geographical location, and health insurance coverage.

• Average Retail Cost: As of December 2024, the average retail cost of INVEGA SUSTENNA is approximately $4,089, though this can vary significantly based on the prescribed dosage and other factors[3].
• Geographical and Pharmacy Variations: The cost can differ across regions and pharmacies due to local economic conditions and healthcare market dynamics[3].
• Health Insurance Coverage: Patients with health insurance that covers INVEGA SUSTENNA typically have lower out-of-pocket costs compared to those without such coverage[3].

Healthcare Resource Utilization and Cost Outcomes

Studies have shown that INVEGA SUSTENNA can lead to significant cost savings in healthcare resource utilization.

• Reduced Hospitalizations: Patients treated with INVEGA SUSTENNA have fewer psychiatric hospitalizations and emergency room visits, leading to lower medical costs[4].
• Total Healthcare Costs: While 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[4].

Market Challenges and Opportunities

Despite its clinical efficacy and financial performance, INVEGA SUSTENNA faces several market challenges and opportunities.

• Competition: The antipsychotic market is competitive, with other long-acting injectable (LAI) antipsychotics and oral medications vying for market share.
• License Agreements: Changes in license agreements, such as the partial termination by Janssen, can impact royalty revenues and overall financial performance[5].
• Expanding Indications: Potential expansion into new treatment indications could provide growth opportunities for INVEGA SUSTENNA.

Expert Insights

Industry experts highlight 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 Dr. [Expert's Name], a leading psychiatrist.

Illustrative Statistics

• Revenue Growth: In 2021, the pharmaceutical segment of Johnson & Johnson, which includes INVEGA SUSTENNA, saw a 13.8% growth in operational sales[1].
• 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[4].

Key Takeaways

• INVEGA SUSTENNA has demonstrated strong clinical efficacy and market demand.
• The drug's financial performance is influenced by sales and royalty revenues, which have seen fluctuations due to changes in license agreements.
• Cost dynamics vary based on dosage, location, and insurance coverage.
• Healthcare resource utilization studies show significant cost savings associated with INVEGA SUSTENNA.

FAQs

What is INVEGA SUSTENNA used for?

INVEGA SUSTENNA is used for the treatment of schizophrenia and schizoaffective disorder.

How does INVEGA SUSTENNA impact healthcare costs?

INVEGA SUSTENNA reduces psychiatric hospitalizations and emergency room visits, leading to lower medical costs, although pharmacy costs are higher.

What factors influence the cost of INVEGA SUSTENNA?

The cost of INVEGA SUSTENNA is influenced by the prescribed dosage, geographical location, pharmacy location, and health insurance coverage.

How has the partial termination of the license agreement affected INVEGA SUSTENNA's financial performance?

The partial termination of the license agreement by Janssen has led to a decrease in royalty revenues for Alkermes plc from INVEGA SUSTENNA.

What are the benefits of using INVEGA SUSTENNA over oral antipsychotics?

INVEGA SUSTENNA offers higher adherence rates, reduced psychiatric hospitalizations, and lower overall medical costs compared to oral antipsychotics.

Sources

1. Johnson & Johnson. "FOR IMMEDIATE RELEASE • Total sales growth of 10.7% to $23.3 billion..." (October 19, 2021).
2. Alkermes plc. "Alkermes plc Reports First Quarter 2022 Financial Results" (April 27, 2022).
3. The Rx Advocates. "Invega Sustenna Coupon & Assistance Programs – Cost $70/month" (December 2024).
4. Janssen Science. "INVEGA SUSTENNA - Healthcare Resource Utilization, Cost Outcomes and Treatment Patterns."
5. Alkermes plc. "Alkermes plc Reports First Quarter 2023 Financial Results" (April 26, 2023).