ILOPERIDONE - Generic Drug Details

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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
Patient-Centered Outcomes Research Institute	Phase 4
Melissa Delbello	Phase 4

See all ILOPERIDONE clinical trials

Generic filers with tentative approvals for ILOPERIDONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	8MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	ILOPERIDONE	iloperidone	TABLET;ORAL	206890-007	May 5, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	ILOPERIDONE	iloperidone	TABLET;ORAL	207098-004	Jul 22, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Inventia	ILOPERIDONE	iloperidone	TABLET;ORAL	207231-007	Nov 28, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-004	May 6, 2009		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-007	May 6, 2009		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ILOPERIDONE

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

EU/EMA Drug Approvals for ILOPERIDONE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ILOPERIDONE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010117941		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010117937		⤷ Sign Up
Spain	2792126		⤷ Sign Up
European Patent Office	2417267	MÉTHODE DE TRAITEMENT BASÉE SUR LES POLYMORPHISMES DU GÈNE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008121899		⤷ Sign Up
Japan	5881597		⤷ Sign Up
Hungary	E030667		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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