FANAPT Drug Patent Profile

Which patents cover Fanapt, and when can generic versions of Fanapt launch?

Fanapt is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in eight countries.

The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iloperidone profile page.

DrugPatentWatch^® Generic Entry Outlook for Fanapt

Fanapt was eligible for patent challenges on May 6, 2013.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (iloperidone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FANAPT

International Patents:	59
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	8
Patent Applications:	3,012
Drug Prices:	Drug price information for FANAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FANAPT
What excipients (inactive ingredients) are in FANAPT?	FANAPT excipients list
DailyMed Link:	FANAPT at DailyMed

See drug prices for FANAPT

Recent Clinical Trials for FANAPT

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

Sponsor	Phase
Vanda Pharmaceuticals	Phase 2
University of Colorado, Denver	Phase 2
Novartis Pharmaceuticals	Phase 2

See all FANAPT clinical trials

Pharmacology for FANAPT

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for FANAPT

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 FANAPT

FANAPT is protected by nine 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
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-004	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-006	May 6, 2009		RX	Yes	No
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009		RX	Yes	No

Expired US Patents for FANAPT

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

EU/EMA Drug Approvals for FANAPT

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 FANAPT

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006710
Germany	69021645
Australia	640653
Russian Federation	2216545	ГЕТЕРОАРИЛ-1-ПИПЕРИДИНЫ И ПИПЕРАЗИНЫ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ИХ ОСНОВЕ, СПОСОБ ЛЕЧЕНИЯ ПСИХОЗОВ И ОСЛАБЛЕНИЯ БОЛИ (HETEROARYL-1-PIPERIDINES AND PIPERAZINES, PHARMACEUTICAL COMPOSITION BASED ON THEREOF, METHOD FOR TREATMENT OF PSYCHOSIS AND PAIN RELIEF)
Canada	2757717	PROCEDE DE PREDICTION D'UNE PREDISPOSITION A UNE PROLONGATION DE QT (METHOD OF PREDICTING A PREDISPOSITION TO QT PROLONGATION)

FANAPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fanapt (Iloperidone)

Introduction

Fanapt, developed by Vanda Pharmaceuticals, is an antipsychotic medication that has recently gained FDA approval for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. This approval marks a significant milestone in the drug's history, which began with its initial FDA approval for schizophrenia in 2009.

Historical Background

Fanapt was first approved by the FDA in 2009 for the treatment of schizophrenia. Despite initial rejection in 2008 due to insufficient clinical data, the drug was eventually cleared after additional studies were conducted[1][5].

Mechanism of Action

Fanapt functions by inhibiting dopamine type 2 and serotonin type 2 receptors, although the precise mechanism of action remains unidentified according to its label[1].

Initial Market Performance

When introduced, analysts predicted that Fanapt could achieve sales of up to $300 million by 2013. However, the drug fell short of these projections, with sales growing gradually over the years. By 2021, Fanapt's sales reached a high point of $95 million, and in the following year, it generated $90 million in revenue[1].

Recent FDA Approval for Bipolar Disorder

In April 2024, the FDA approved Fanapt for the treatment of manic or mixed episodes linked to bipolar I disorder in adults. This approval significantly expands the addressable patient population and is expected to boost Vanda's revenue. The approval led to a 33% surge in Vanda’s shares during post-market trading[1][5].

Financial Impact of the New Approval

The recent approval for bipolar disorder is expected to enhance Fanapt's market position. Vanda is initiating various commercial activities, including expanding its sales force, prescriber awareness programs, and comprehensive marketing campaigns to capitalize on this new indication. This strategic move is anticipated to increase revenue and offset recent declines in sales of other Vanda products, such as Hetlioz (tasimelteon), which has faced significant generic competition in the U.S.[1][3].

Quarterly Financial Performance

In the first quarter of 2024, Fanapt's net product sales were $20.6 million, a 10% decrease compared to $22.9 million in the first quarter of 2023. Despite this decline, the overall revenue from Vanda's products, including HETLIOZ and PONVORY, was $47.5 million, a 5% increase compared to the fourth quarter of 2023[3].

Competitive Landscape

The approval of Fanapt for bipolar disorder places it in a competitive market. Other companies, such as Lyndra Therapeutics, are developing new treatments for bipolar disorder. Lyndra's LYN-005, currently in late-stage development, could pose a significant threat to Fanapt's market share if it demonstrates superior efficacy, fewer side effects, or a more convenient dosing regimen[1].

Impact of Generic Competition

Vanda has faced challenges due to generic competition, particularly with its product Hetlioz. The rise of generic alternatives in the U.S. has led to a significant decline in Hetlioz sales, from $160 million in 2022 to $100 million in the previous year. This decline underscores the importance of new approvals and product diversification for Vanda's financial stability[1][3].

Strategic Acquisitions and Diversification

To offset revenue losses, Vanda has invested $100 million to acquire the rights for Johnson & Johnson’s PONVORY, a treatment for multiple sclerosis, in the U.S. and Canada. This acquisition was finalized in December 2023 and is expected to contribute to Vanda's revenue growth[1][3].

Operational Highlights and Future Outlook

Vanda's financial highlights for the first quarter of 2024 include a cash balance of $394.1 million, representing an increase of $5.9 million compared to the end of 2023. The company is focused on commercializing new treatments, including the upcoming launch of PONVORY and the continued development of its pipeline, such as the NDA submission for milsaperidone expected in early 2025[3].

Psychiatry Portfolio

• Fanapt (Iloperidone): The recent FDA approval for acute bipolar I disorder is a significant step forward. Vanda is initiating commercial activities to leverage this new indication.
• HETLIOZ (Tasimelteon): Despite facing generic competition, HETLIOZ remains a key product, though its sales have declined significantly.
• PONVORY: The commercial launch of PONVORY is expected in Q3 2024, adding another revenue stream for Vanda[3].

Key Financial Metrics

• Revenue: Total net product sales from Fanapt, HETLIOZ, and PONVORY were $47.5 million in the first quarter of 2024.
• Operating Expenses: Total operating expenses were $56.7 million, with research and development expenses being $21.1 million.
• Cash Position: Vanda's cash, cash equivalents, and marketable securities stood at $394.1 million as of March 31, 2024[3].

Market Challenges and Opportunities

The market for antipsychotic medications is highly competitive, with several players vying for market share. However, the recent approval of Fanapt for bipolar disorder presents a significant opportunity for Vanda to expand its market presence. The company must navigate the challenges posed by generic competition and the potential entry of new treatments like Lyndra's LYN-005.

Competitive Threats

• LYN-005 by Lyndra Therapeutics: If approved, this drug could offer superior efficacy or a more convenient dosing regimen, potentially attracting physicians and patients away from Fanapt.
• Generic Competition: The rise of generic alternatives continues to impact Vanda's revenue, particularly for HETLIOZ[1].

Market Opportunities

• Expanded Indications: The new approval for bipolar disorder significantly expands the addressable patient population for Fanapt.
• Strategic Acquisitions: The acquisition of PONVORY and potential future acquisitions could diversify Vanda's revenue streams and mitigate risks associated with single-product reliance[1][3].

Conclusion

The recent FDA approval of Fanapt for the treatment of manic or mixed episodes associated with bipolar I disorder marks a pivotal moment for Vanda Pharmaceuticals. This approval, combined with strategic acquisitions and a diverse product pipeline, positions Vanda for potential growth despite the competitive landscape and challenges from generic competition.

Key Takeaways

• New FDA Approval: Fanapt has been approved for the treatment of manic or mixed episodes in bipolar I disorder, expanding its market potential.
• Financial Performance: Despite a decline in Fanapt's sales in Q1 2024, Vanda's overall revenue remains stable, with a strong cash position.
• Competitive Landscape: The entry of new treatments and generic competition pose challenges, but Vanda's strategic moves aim to maintain and grow its market share.
• Future Outlook: Vanda is focused on commercializing new treatments and expanding its product portfolio to ensure long-term financial stability.

FAQs

What is Fanapt used for?

Fanapt (iloperidone) is an antipsychotic medication used for the treatment of schizophrenia and, as of April 2024, for the treatment of manic or mixed episodes associated with bipolar I disorder in adults[1][5].

How does Fanapt work?

Fanapt works by inhibiting dopamine type 2 and serotonin type 2 receptors, although the precise mechanism of action remains unidentified according to its label[1].

What was the impact of the new FDA approval on Vanda's shares?

The FDA approval of Fanapt for bipolar disorder led to a 33% surge in Vanda’s shares during post-market trading[1].

How has generic competition affected Vanda's revenue?

Generic competition, particularly for HETLIOZ, has led to a significant decline in sales. For example, HETLIOZ sales dropped from $160 million in 2022 to $100 million in the previous year[1][3].

What are Vanda's future plans to offset revenue losses?

Vanda has invested in acquiring the rights for Johnson & Johnson’s PONVORY and is focused on commercializing new treatments, including the upcoming launch of PONVORY and the continued development of its pipeline[1][3].

Sources

1. DelveInsight: Vanda's Fanapt Approval for Bipolar Disorder Treatment.
2. Biospace: Vanda Pharmaceuticals Reports First Quarter 2018 Financial Results.
3. Vanda Pharmaceuticals: Vanda Pharmaceuticals Reports First Quarter 2024 Financial Results.
4. Vanda Pharmaceuticals: Vanda Pharmaceuticals Reports Second Quarter 2019 Financial.
5. PharmExec: FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder.