Nitisinone - Generic Drug Details

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 Medunik, Novitium Pharma, Swedish Orphan, and Cycle Pharms Ltd, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nitisinone has thirty-seven patent family members in twenty-five countries.

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

Summary for nitisinone

International Patents:	37
US Patents:	2
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	16
Patent Applications:	970
Drug Prices:	Drug price trends for nitisinone
What excipients (inactive ingredients) are in nitisinone?	nitisinone excipients list
DailyMed Link:	nitisinone at DailyMed

See drug prices for nitisinone

Recent Clinical Trials for nitisinone

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

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

See all nitisinone clinical trials

Pharmacology for nitisinone

Drug Class	4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2E1 Inducers Hydroxyphenylpyruvate Dioxygenase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 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
Medunik	NITISINONE	nitisinone	CAPSULE;ORAL	212390-001	May 26, 2022	AB	RX	No	No
Cycle Pharms Ltd	NITYR	nitisinone	TABLET;ORAL	209449-001	Jul 26, 2017		RX	Yes	No			Y
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002	AB	RX	Yes	No
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes			Y
Medunik	NITISINONE	nitisinone	CAPSULE;ORAL	212390-003	May 26, 2022	AB	RX	No	No
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-001	Jan 18, 2002	AB	RX	Yes	No
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	021232-003	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

EU/EMA Drug Approvals for nitisinone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
MendeliKABS Europe Ltd	Nitisinone MDK (previously Nitisinone MendeliKABS)	nitisinone	EMEA/H/C/004281 Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.	Authorised	yes	no	no	2017-08-24
Cycle Pharmaceuticals (Europe) Ltd	Nityr	nitisinone	EMEA/H/C/004582 Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	Authorised	yes	no	no	2018-07-26
Swedish Orphan Biovitrum International AB	Orfadin	nitisinone	EMEA/H/C/000555 Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).	Authorised	no	no	no	2005-02-20

International Patents for nitisinone

Country	Patent Number	Title	Estimated Expiration
Ukraine	110979	РІДКА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ВКЛЮЧАЄ НІТИЗИНОН (LIQUID PHARMACEUTICAL FORMULATION COMPRISING NITISINONE)
Australia	2012273515	Liquid pharmaceutical composition comprising nitisinone
Poland	2723320
Canada	2935013	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA NITISINONE ET UTILISATION (PHARMACEUTICAL COMPOSITION CONTAINING NITISINONE, AND ITS USE)
Cyprus	1117273
San Marino	T201600097	COMPOSIZIONE FARMACEUTICA LIQUIDA CHE COMPRENDE NITISONE
World Intellectual Property Organization (WIPO)	2012177214

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