ILOPERIDONE - Generic Drug Details

What are the generic drug sources for iloperidone and what is the scope of patent protection?

Iloperidone is the generic ingredient in two branded drugs marketed by Vanda Pharms Inc, Inventia, Lupin Ltd, and Taro, and is included in four NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Iloperidone has fifty-nine patent family members in eight countries.

There are eight drug master file entries for iloperidone. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ILOPERIDONE

International Patents:	59
US Patents:	9
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	23
Patent Applications:	4,519
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILOPERIDONE
What excipients (inactive ingredients) are in ILOPERIDONE?	ILOPERIDONE excipients list
DailyMed Link:	ILOPERIDONE at DailyMed

Recent Clinical Trials for ILOPERIDONE

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

Sponsor	Phase
Vanda Pharmaceuticals	Phase 2
Melissa Delbello	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4

See all ILOPERIDONE clinical trials

Generic filers with tentative approvals for ILOPERIDONE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET;ORAL
		8MG	TABLET;ORAL
		6MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ILOPERIDONE

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ILOPERIDONE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ILOPERIDONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FANAPT	Tablets	iloperidone	1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg	022192	1	2013-05-06

US Patents and Regulatory Information for ILOPERIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009		RX	Yes	No
Taro	ILOPERIDONE	iloperidone	TABLET;ORAL	207098-007	Jul 22, 2019		DISCN	No	No
Inventia	ILOPERIDONE	iloperidone	TABLET;ORAL	207231-001	Nov 28, 2016		DISCN	No	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-007	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-007	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-001	May 6, 2009		RX	Yes	Yes

Expired US Patents for ILOPERIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-007	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-001	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-004	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-006	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-003	May 6, 2009

EU/EMA Drug Approvals for ILOPERIDONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vanda Pharmaceuticals Ltd	Fanaptum	iloperidone	EMEA/H/C/004149 Treatment of schizophrenia	Refused	no	no	no		2018-01-15

International Patents for ILOPERIDONE

Country	Patent Number	Title	Estimated Expiration
Canada	2757717	PROCEDE DE PREDICTION D'UNE PREDISPOSITION A UNE PROLONGATION DE QT (METHOD OF PREDICTING A PREDISPOSITION TO QT PROLONGATION)
Spain	2542967
European Patent Office	2479290	Procédés pour l'administration de l'ilopéridone (Methods for the administration of iloperidone)
Canada	2582022	METHODES D'ADMINISTRATION D'ILOPERIDONE (METHODS FOR THE ADMINISTRATION OF ILOPERIDONE)
Japan	2012502105
European Patent Office	3354753	PROCÉDÉ DE TRAITEMENT À BASESDE POLYMORPHISMES DU GÈNE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)
Japan	2012522838

ILOPERIDONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iloperidone

Introduction to Iloperidone

Iloperidone, marketed under the brand name Fanapt, is an atypical antipsychotic drug primarily used for the treatment of schizophrenia. It is characterized by its mixed 5-HT(2A)/D(2) receptor antagonist profile, which distinguishes it from other antipsychotics by its lower incidence of extrapyramidal symptoms and weight gain[4].

Market Segmentation and Analysis

The iloperidone market can be segmented based on type and application.

Type

• Brand Drugs: The brand segment, which includes Fanapt, has historically held a significant share of the global iloperidone market. However, this segment is facing challenges due to the emergence of generic alternatives[1].
• Generic Drugs: Generic versions of iloperidone are increasingly impacting the market, particularly in regions like the U.S. where generic launches have led to a decline in brand drug sales[2].

Application

• Schizophrenia: This remains the primary application for iloperidone, with the drug being used as a treatment option for patients with schizophrenia. The schizophrenia segment is expected to continue growing, albeit at a significant CAGR[1].
• Other Applications: While schizophrenia is the main use, there are ongoing efforts to explore other potential applications, although these are not as prominent as the schizophrenia market.

Financial Performance and Trends

Revenue and Sales

• Historical Sales: When introduced, iloperidone was expected to achieve significant sales, with projections as high as $300 million by 2013. However, it fell short of these projections, reaching a peak of $95 million in 2021 and $90 million in the subsequent year[5].
• Current Decline: The recent financial performance of Vanda Pharmaceuticals, the primary marketer of Fanapt, shows a decline in revenue. Total net product sales from Fanapt decreased by 4% in 2023 compared to 2022, largely due to the at-risk launch of generic versions in the U.S.[2].

Impact of Generic Competition

• The introduction of generic versions of iloperidone has significantly impacted Vanda Pharmaceuticals' revenue. For instance, the launch of generic HETLIOZ (tasimelteon), another product by Vanda, led to a 37% decrease in its sales from 2022 to 2023[2].

Strategic Moves and Acquisitions

• Acquisition of PONVORY: Vanda Pharmaceuticals acquired PONVORY, a treatment for relapsing forms of multiple sclerosis, from Johnson & Johnson. This acquisition is part of Vanda's strategy to diversify its product portfolio and offset the decline in revenue from its existing products. However, the initial sales post-acquisition have been modest at $1.6 million[2].

Market Drivers and Opportunities

Growing Demand for Atypical Antipsychotics

• The market for atypical antipsychotics, including iloperidone, is driven by the expanding need for effective treatments for schizophrenia and other psychiatric disorders. Iloperidone's favorable receptor profile and lower side effect incidence make it a preferred option in this segment[4].

Clinical Development and Pipeline

• Vanda Pharmaceuticals is advancing its clinical development pipeline with submissions for new indications such as insomnia, bipolar disorder, and gastroparesis. These developments are crucial for the company's future growth and could provide new revenue streams[2].

Market Restraints and Challenges

Generic Competition

• The emergence of generic versions of iloperidone is a significant restraint on the market. Generic competition has led to a decline in sales for brand drugs, affecting the overall revenue of companies like Vanda Pharmaceuticals[2].

Regulatory Challenges

• Regulatory hurdles, such as the FDA's recent denial of Vanda's insomnia treatment HETLIOZ, pose challenges to the company's growth. These setbacks can impact the company's ability to expand its product portfolio and increase revenue[5].

Competitive Landscape

• The market for schizophrenia treatments is highly competitive, with other companies like Lyndra Therapeutics developing new assets. The potential approval of Lyndra's LYN-005 could pose a significant threat to Fanapt's market share if it demonstrates superior efficacy or a more convenient dosing regimen[5].

Regional Analysis

Global Market

• The global iloperidone market is analyzed across major regions including North America, Europe, Asia-Pacific, and South America. Each region has its unique market dynamics, with North America being a significant market due to the presence of major pharmaceutical companies and a well-established healthcare system[1].

Regional Trends

• The North America market, for instance, is characterized by a high level of generic competition and stringent regulatory environments. Europe and Asia-Pacific regions also show promising growth potential due to increasing healthcare spending and a growing patient population[1].

Financial Trajectory

Current Financial Status

• Vanda Pharmaceuticals reported a net loss of $2.4 million in the fourth quarter of 2023, compared to a net income of $6.9 million in the same period of 2022. The company's cash reserves also decreased by $78.6 million year-over-year, partly due to the acquisition of PONVORY[2].

Future Outlook

• Despite current challenges, Vanda's strategic moves, such as the acquisition of PONVORY and advancements in its clinical development pipeline, indicate potential for future growth. However, the company's financial trajectory will depend on how it navigates generic competition, regulatory challenges, and the competitive landscape[2].

Key Takeaways

• Iloperidone's market is segmented into brand and generic drugs, with the schizophrenia segment being the most lucrative.
• The emergence of generic versions significantly impacts revenue.
• Vanda Pharmaceuticals is diversifying its portfolio through acquisitions like PONVORY.
• Regulatory challenges and competitive threats from new assets are key restraints.
• The company's financial trajectory is influenced by its ability to navigate these challenges and advance its clinical pipeline.

FAQs

Q: What is the primary use of iloperidone?

• Iloperidone is primarily used for the treatment of schizophrenia.

Q: How has the introduction of generic versions affected the market?

• The introduction of generic versions has led to a significant decline in sales for brand drugs like Fanapt.

Q: What strategic moves has Vanda Pharmaceuticals made to offset revenue decline?

• Vanda has acquired PONVORY and is advancing its clinical development pipeline to diversify its product portfolio.

Q: What are the key challenges facing Vanda Pharmaceuticals in the iloperidone market?

• The company faces challenges from generic competition, regulatory hurdles, and a competitive landscape with new assets being developed.

Q: What is the expected growth trajectory for the iloperidone market?

• The market is expected to grow, driven by the expanding need for effective schizophrenia treatments, but will be influenced by the company's ability to navigate current challenges.

Sources

1. Cognitive Market Research: Iloperidone Drugs Market Report 2024 (Global Edition)
2. Stock Titan: Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results
3. DataIntelo: Global Iloperidone API Market Report
4. PubMed: An assessment of iloperidone for the treatment of schizophrenia
5. DelveInsight: Vanda's Fanapt Approval for Bipolar Disorder Treatment