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Nitisinone - Generic Drug Details

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

Nitisinone is the generic ingredient in three branded drugs marketed by Novitium Pharma, Swedish Orphan, and Cycle Pharms Ltd, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nitisinone has twenty-seven patent family members in twenty-two countries.

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

Summary for nitisinone

International Patents:	27
US Patents:	2
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	90
Clinical Trials:	16
Patent Applications:	329
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nitisinone
DailyMed Link:	nitisinone at DailyMed

Recent Clinical Trials for nitisinone

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

Sponsor	Phase
Sutphin Drugs	N/A
Parexel	Phase 1
Cycle Pharmaceuticals Ltd.	Phase 1

See all nitisinone clinical trials

Generic filers with tentative approvals for NITISINONE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET;ORAL
		5MG	TABLET;ORAL
		2MG	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 nitisinone

Drug Class	4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of Action	Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors

Synonyms for nitisinone

1,3-Cyclohexanedione, 2-(2-nitro-4-(trifluoromethyl)benzoyl)-

1,3-Cyclohexanedione, 2-[2-nitro-4-(trifluoromethyl)benzoyl]-

1,3-Cyclohexanedione,2-[2-nitro-4-(trifluoromethyl)benzoyl]-

104206-65-7

1246815-63-3

2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione

2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

2-(2-Nitro-4-trifluoromethylbenzoyl)cyclohexane-1,3-dione

2-(Alpha,alpha,alpha-trifluoro-2-nitro-p-tuluoyl)-1,3-cyclohexanedione

2-[[2-nitro-4-(trifluoromethyl)phenyl]-oxomethyl]cyclohexane-1,3-dione

2-[2-Nitro-4-(trifluoromethyl)benzoyl]-1,3-cyclohexanedione

2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione

2-[2-nitro-4-(trifluoromethyl)phenyl]carbonylcyclohexane-1,3-dione

2-{[2-nitro-4-(trifluoromethyl)phenyl]carbonyl}cyclohexane-1,3-dione

4CH-014643

A800922

AB0034533

ABP000997

AC-26934

AC1L3GZK

ACN-035825

AK-55736

AKOS015891363

AKOS015994590

AM62666

AMBZ0071

AN-5675

ANW-54114

API0003588

AX8061457

BCP15276

BDBM50088804

BG0491

BIDD:PXR0129

C14H10F3NO5

CCG-222085

CHEBI:50378

CHEMBL1337

CS-2825

CTK8B6714

D05177

DB00348

DTXSID9042673

EX-6233

FE-0200

FT-0672739

GTPL6834

HY-B0607

I01-9620

J-505680

K5BN214699

KB-66754

KS-00000MEI

LS-56815

MCULE-6109734568

MFCD01752192

MLS004774025

MLS006011955

MolPort-006-167-523

MP-1670

NCGC00185778-01

NCGC00185778-02

nitisinona

Nitisinone (JAN/USAN/INN)

Nitisinone (NTBC)

Nitisinone [INN]

Nitisinone [USAN:INN]

Nitisinone-13C6

Nitisinone, >=95% (HPLC)

nitisinonum

Nitisone

NTBC

Orfadin

Orfadin (TN)

PubChem7541

QC-508

RB3134

RL00201

RT-014721

SB19017

SC 0735

SC-00174

SC-0735

SCHEMBL15996621

SCHEMBL338795

SMR002529592

SR-01000940576

SR-01000940576-2

ST2419751

UNII-K5BN214699

X8704

Z1514110653

ZINC100014475

US Patents and Regulatory Information for nitisinone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle Pharms Ltd	NITYR	nitisinone	TABLET;ORAL	209449-003	Jul 26, 2017		RX	Yes	Yes			Y
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes
Cycle Pharms Ltd	NITYR	nitisinone	TABLET;ORAL	209449-001	Jul 26, 2017		RX	Yes	No			Y
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-004	Jun 13, 2016		RX	Yes	Yes
Novitium Pharma	NITISINONE	nitisinone	CAPSULE;ORAL	211041-001	Aug 26, 2019	AB	RX	No	No
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	AB	RX	Yes	No

Expired US Patents for nitisinone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	Jan 18, 2002

International Patents for nitisinone

Country	Patent Number	Estimated Expiration
Serbia	54632
Croatia	P20160286
China	103747781
Canada	2838039
Brazil	112013033008
Canada	2935013

Supplementary Protection Certificates for nitisinone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
0591275	C300198	Netherlands		PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0591275	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221