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Generated: October 16, 2018

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ORFADIN Drug Profile

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Which patents cover Orfadin, and what generic alternatives are available?

Orfadin is a drug marketed by Swedish Orphan and is included in two NDAs. There is one patent protecting this drug.

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

Drug patent expirations by year for ORFADIN
Synonyms for ORFADIN
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
Nitisinone (JAN/USAN/INN)
Nitisinone (NTBC)
Nitisinone [INN]
Nitisinone [USAN:INN]
Nitisinone-13C6
Nitisinone, >=95% (HPLC)
nitisinonum
Nitisone
NTBC
OR068039
OR112861
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 ORFADIN

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 021232-001 Jan 18, 2002 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ORFADIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ORFADIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/030 United Kingdom ➤ Try a Free Trial 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
00198 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free Trial PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Moodys
Queensland Health
Julphar
Healthtrust
Colorcon
QuintilesIMS
Baxter
Federal Trade Commission

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