NITISINONE - Generic Drug Details

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

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

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

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

Summary for NITISINONE

International Patents:	38
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	16
Patent Applications:	784
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
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	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 NITISINONE

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 NITISINONE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	NITISINONE	nitisinone	CAPSULE;ORAL	211041-003	Aug 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201-004	May 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NITISINONE

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

EU/EMA Drug Approvals for NITISINONE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for NITISINONE

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Country	Patent Number	Title	Estimated Expiration
Lithuania	3089740		⤷ Sign Up
Ukraine	110979	РІДКА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ВКЛЮЧАЄ НІТИЗИНОН (LIQUID PHARMACEUTICAL FORMULATION COMPRISING NITISINONE)	⤷ Sign Up
Mexico	2013014567	COMPOSICION FARMACEUTICA LIQUIDA QUE COMPRENDE NITISINONA. (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012177214		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NITISINONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591275	05C0024	France	⤷ Sign Up	PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275	C300198	Netherlands	⤷ Sign Up	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	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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