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Nitisinone - Generic Drug Details

What are the generic sources for nitisinone and what is the scope of nitisinone freedom to operate?

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

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

Summary for nitisinone

US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	82
Clinical Trials:	15
Patent Applications:	286
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nitisinone
DailyMed Link:	nitisinone at DailyMed

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
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
3B1-000198
4CH-014643
A800922
AB0034533
ABP000997
AC-26934
AC1L3GZK
ACN-035825
AK-55736
AKOS015891363
AKOS015994590
AM62666
AMBZ0071
AN-5675
ANW-54114
API0003588
AX8061457
BDBM50088804
BG0491
BIDD:PXR0129
C14H10F3NO5
CCG-222085
CHEBI:50378
CHEMBL1337
CS-2825
CTK8B6714
D05177
D0V1UW
DB00348
DTXSID9042673
EX-6233
FE-0200
FT-0672739
GTPL6834
HY-B0607
I01-9620
IN008917
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
OR068039
OR112861
Orfadin
Orfadin (TN)
PubChem7541
QC-508
RB3134
RL00201
RT-014721
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

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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
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-003	Jan 18, 2002		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Swedish Orphan	ORFADIN	nitisinone	CAPSULE;ORAL	021232-002	Jan 18, 2002		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Cycle Pharms Ltd	NITYR	nitisinone	TABLET;ORAL	209449-001	Jul 26, 2017		RX	Yes	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	021232-003	Jan 18, 2002	➤ Sign Up	➤ Sign Up
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	021232-002	Jan 18, 2002	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for nitisinone

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Country	Document Number	Estimated Expiration
Brazil	112013033008	➤ Sign Up
Ukraine	110979	➤ Sign Up
Japan	6038132	➤ Sign Up
China	103747781	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for nitisinone

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00198	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
C0024	France	➤ Sign Up	PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
C/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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description