NITYR Drug Patent Profile

When do Nityr patents expire, and what generic alternatives are available?

Nityr is a drug marketed by Cycle and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in fourteen countries.

The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nityr

A generic version of NITYR was approved as nitisinone by NOVITIUM PHARMA on August 26^th, 2019.

Summary for NITYR

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	499
Drug Prices:	Drug price information for NITYR
What excipients (inactive ingredients) are in NITYR?	NITYR excipients list
DailyMed Link:	NITYR at DailyMed

See drug prices for NITYR

Pharmacology for NITYR

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

Anatomical Therapeutic Chemical (ATC) Classes for NITYR

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for NITYR

NITYR is protected by one US patents.

Patents protecting NITYR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-001	Jul 26, 2017		RX	Yes	No			Y
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-002	Jul 26, 2017		RX	Yes	No			Y
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-003	Jul 26, 2017		RX	Yes	Yes			Y

EU/EMA Drug Approvals for NITYR

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.	Withdrawn	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	2005-02-21

International Patents for NITYR

See the table below for patents covering NITYR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2935013	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA NITISINONE ET UTILISATION (PHARMACEUTICAL COMPOSITION CONTAINING NITISINONE, AND ITS USE)
Poland	3089740
Serbia	60551	FARMACEUTSKA KOMPOZICIJA (PHARMACEUTICAL COMPOSITION)
Slovenia	3089740
European Patent Office	3089740	COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
World Intellectual Property Organization (WIPO)	2015101794
Lithuania	3089740

Supplementary Protection Certificates for NITYR

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	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 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