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US Department of Justice
Queensland Health
Chubb
Covington
McKesson
Fuji
Cipla
Colorcon
Harvard Business School

Generated: December 10, 2018

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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 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.

Nitisinone has twenty-two patent family members in twenty countries.

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

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

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 209449-002 Jul 26, 2017 RX Yes No ➤ 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
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 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 Y ➤ Sign Up
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Supplementary Protection Certificates for nitisinone

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

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Julphar
Cipla
Harvard Business School
Chubb
Chinese Patent Office
Boehringer Ingelheim
Accenture
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.