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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 freedom to operate?

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 thirty-four patent family members in twenty-five countries.

There are two drug master file entries for nitisinone. Three suppliers are listed for this compound.

Summary for nitisinone

International Patents:	34
US Patents:	2
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	105
Clinical Trials:	16
Patent Applications:	782
What excipients (inactive ingredients) are in nitisinone?	nitisinone excipients list
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

Pharmacology for nitisinone

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

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
Novitium Pharma	NITISINONE	nitisinone	CAPSULE;ORAL	211041-003	Aug 26, 2019	AB	RX	No	No
Novitium Pharma	NITISINONE	nitisinone	CAPSULE;ORAL	211041-001	Aug 26, 2019	AB	RX	No	No
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-004	Jun 13, 2016		RX	Yes	Yes
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	AB	RX	Yes	No
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes
Cycle Pharms Ltd	NITYR	nitisinone	TABLET;ORAL	209449-002	Jul 26, 2017		RX	Yes	No			Y

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	021232-002	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	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

International Patents for nitisinone

Country	Patent Number	Estimated Expiration
Cyprus	1117273
Russian Federation	2014101990
Poland	2723320
Japan	2014517067
Australia	2012273515
Russian Federation	2605301
European Patent Office	3089740

Supplementary Protection Certificates for nitisinone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221