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FANAPT Drug Profile

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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-six patent family members in eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Fanapt

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

There have been nine 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:	56
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	98
Clinical Trials:	6
Patent Applications:	1,363
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FANAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FANAPT
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
Novartis Pharmaceuticals	Phase 2
University of Colorado, Denver	Phase 2
Novartis Pharmaceuticals	Phase 4

See all FANAPT clinical trials

Recent Litigation for FANAPT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals	2016-09-26
Vanda Pharmaceuticals Inc. v. Apotex Inc.	2015-10-13
Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited	2015-10-13

See all FANAPT litigation

PTAB Litigation

Petitioner	Date
	2016-02-26

See all FANAPT litigation

Pharmacology for FANAPT

Drug Class

Atypical Antipsychotic

Synonyms for FANAPT

(non-Isotopelabelled)Iloperidone-d6

1-(4-(3-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)propoxy)-3-methoxyphenyl)ethanone

1-(4-(3-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)propoxy)-3-methoxyphenyl)ethan-1-one

1-(4-(3-(4-(6-Fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)propoxy)-3-methoxyphenyl)ethanone

1-(4-{3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy}-3-methoxyphenyl)ethan-1-one

1-(4-{3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy}-3-methoxyphenyl)ethanone

1-(4-{3-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-propoxy}-3-methoxy-phenyl)-ethanone

1-(4-{3-[4-(6-fluoro-benzo[d]isoxazol-3-yl)piperidin-1-yl]-propoxy}-3-methoxy-phenyl)-ethanone

1-(4-{3-[4-(6-fluoro-benzo[d]isoxazol-3-yl)piperidin-1-yl]propoxy}-3-methoxy-phenyl)-ethanone

1-[4-[3-[4-(6-fluoranyl-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxy-phenyl]ethanone

1-[4-[3-[4-(6-fluoro-1, 2-benzisoxazol-3-yl)-1-piperidinyl]-propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3- methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1- piperidinyl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperdinyl]propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]- propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-propoxy]-3methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-propoxyl]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-phenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl] ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]-propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-piperidinyl]propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-piperidinyl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)1-piperidinyl]-propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3yl)-1-piperidinyl]propoxy]-3-methoxyphenyl] ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]-ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-(trideuteriomethoxy)phenyl]ethanone

1-[4-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone

1-[4-[3-[4(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-propoxy]-3-methoxyphenyl]-ethanone

133454-47-4

133454-47-4,1299470-39-5(HCl)

4'-(3-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino)propoxy)-3'-methoxyacetophenone

454I474

4CA-0635

A806617

AB0005018

AB01274793_02

AB01274793-01

AB2000121

ABP000554

AC-3482

ACT02698

AKOS005146266

AM20090764

AOB6366

BCP02042

BCP9000774

BCPP000206

BDBM50034043

C24H27FN2O4

CAS-133454-47-4

CHEBI:65173

CHEMBL14376

CI0025

CS-1236

CTK8E8760

D02666

DB04946

DSSTox_CID_28986

DSSTox_GSID_49060

DSSTox_RID_83251

DTXSID6049060

Ethanone, 1-(4-(3-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)propoxy)-3-methoxyphenyl)-

Ethanone, 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]-

Fanapt (TN)

Fanapta

Fanapta;Zomaril;Fanapt

Fiapta

FT-0084590

FT-0631148

GTPL87

HMS3604B21

HMS3654J14

HP 873

HP-873

HP873

HSDB 8207

HY-17410

I0926

ILO-522

iloperidona

Iloperidone

Iloperidone (Fanapt)

Iloperidone (USAN/INN)

Iloperidone [USAN:INN:BAN]

Iloperidone [USAN:INN]

Iloperidone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Iloperidone-d6

Iloperidone, >=98% (HPLC)

Iloperidone, United States Pharmacopeia (USP) Reference Standard

Iloperidone(Fanapt)

Iloperidone(Fanapt)/

iloperidonum

J-503185

KS-00000Z5H

L001176

LS-172870

MCULE-1792333504

MLS004774132

MLS006011943

NCGC00188864-01

NCGC00188864-02

PDSP1_000514

PDSP1_000515

PDSP2_000512

PDSP2_000513

Q4199443

RTC-070929

s1483

SCHEMBL115755

SMR002529575

SR-01000940095

SR-01000940095-2

SW219279-1

TC-070929

Tox21_113610

Tox21_113610_1

UNII-VPO7KJ050N

VA11078

VPO7KJ050N

W-5150

XMXHEBAFVSFQEX-UHFFFAOYSA-N

Z1691545119

ZINC000001548097

ZINC1548097

Zomaril

Zomaril|||Fanapt

Paragraph IV (Patent) Challenges for FANAPT

Tradename	Dosage	Ingredient	NDA	Submissiondate
FANAPT	TABLET;ORAL	iloperidone	022192	2013-05-06

US Patents and Regulatory Information for FANAPT

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

Expired US Patents for FANAPT

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

International Patents for FANAPT

Country	Patent Number	Estimated Expiration
Czech Republic	282385
Norway	941647
Austria	356123
Finland	942052