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Generated: May 21, 2018

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Leflunomide - Generic Drug Details

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

Leflunomide
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alembic Pharms Ltd, Apotex Inc, Barr, Fosun Pharma, Heritage Pharms Inc, Sandoz, and Teva Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for leflunomide. Thirteen suppliers are listed for this compound.
Pharmacology for leflunomide
Synonyms for leflunomide
(5-methylisoxazol-4-yl)-N-[4-(trifluoromethyl)phenyl]carboxamide
210165-51-8
4-Isoxazolecarboxamide, 5-methyl-N-(4-(trifluoromethyl)phenyl
4-Isoxazolecarboxamide, 5-methyl-N-(4-(trifluoromethyl)phenyl)-
4-Isoxazolecarboxamide, 5-methyl-N-[4-(trifluoromethyl)phenyl]-
4-isoxazolecarboxamide,5-methyl-N-(4-(trifluoromethyl)phenyl)
5-methyl-4-(4-trifluoromethyl-phenyl)aminocarbonylisoxazole
5-methyl-4-(4-trifluoromethylphenyl)aminocarbonylisoxazole
5-methyl-n-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamid
5-Methyl-N-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamide
5-methyl-N-(4-(trifluoromethyl)phenyl)isoxazole-4-carboxamide
5-methyl-N-(4-(trifluoromethyl)phenyl)isoxazole-4-carboxamide;
5-methyl-N-[4-(trifluoromethyl)phenyl]-1,2-oxazole-4-carboxamide
5-methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide
5-methyl-N-[4-(trifluoromethyl)phenyl]isoxazole-4-carboxamide
5-Methylisoxazole-4-(4-trifluoromethyl)carboxanilide
5-METHYLISOXAZOLE-4-(4-TRIFLUOROMETHYLCARBOXANILID
5-Methylisoxazole-4-(4-trifluoromethylcarboxanilide)
5-methylisoxazole-4-carboxylic acid (4-trifluoromethyl)-anilide
5-Methylisoxazole-4-carboxylic acid (4-trifluoromethyl)anilide
706L126
75706-12-6
A77 1486
A9622
AB00052389
AB00052389_19
AB00052389_21
AB00052389-17
AB00052389-18
AB0007396
ABP001076
AC-6796
AC1L1GYK
AC1Q2EVA
AJ-08231
AK161855
AKOS000265193
ALBB-019233
alpha,alpha,alpha-Trifluoro-5-methyl-4-isoxazolecarboxy-p-toluidide
AN-9632
AOB5964
AP-501/42475599
Arabloc
Arava
Arava (TN)
Arava, Leflunomide
avara
Aventis Behring Brand of Leflunomide
Aventis Brand of Leflunomide
Aventis Pharma Brand of Leflunomide
BC204155
BCP9000846
BDBM50054601
BIDD:PXR0189
BPBio1_000930
BRD-K78692225-001-03-9
BSPBio_000844
C07905
CAS-75706-12-6
CCG-204736
CHEBI:6402
CHEMBL960
CS-1781
CTK8G0535
D00749
D08ROP
DB01097
DivK1c_000916
DL-433
DR000847
DSSTox_CID_3201
DSSTox_GSID_23201
DSSTox_RID_76923
DTXSID9023201
EBD46417
EU-0100649
FT-0621959
G162GK9U4W
GTPL6825
H527
HE386325
HMS1570K06
HMS1922M06
HMS2090O12
HMS2097K06
HMS2235C07
HMS3262A19
HMS3268D12
HMS3371F21
HMS3654F07
HMS502N18
Hoechst Brand of Leflunomide
HSDB 7289
HWA 486
HWA-486
HY-B0083
I06-2131
IDI1_000916
ISO054
Isoxazole-4-carboxamide, 5-methyl-N-[4-(trifluoromethyl)phenyl]-
KBio1_000916
KBio2_000802
KBio2_003370
KBio2_005938
KBioSS_000802
KS-00000KQI
KS-1076
L 5025
L0250
Leflunomid
Leflunomida
Leflunomida [INN-Spanish]
Leflunomide (JAN/USAN/INN)
Leflunomide [USAN:INN]
Leflunomide [USAN:USP:INN:BAN]
Leflunomide for peak identification, European Pharmacopoeia (EP) Reference Standard
leflunomide medac
Leflunomide, European Pharmacopoeia (EP) Reference Standard
Leflunomide, Immunosuppressant
Leflunomide, pharmaceutical secondary standard; traceable to USP and PhEur
Leflunomide, United States Pharmacopeia (USP) Reference Standard
Leflunomidum
Leflunomidum [INN-Latin]
lefumide
lefunamide
Lefunomide
Lefunomide [Inn-Spanish]
Lopac-L-5025
Lopac0_000649
LP00649
LS-86580
MCULE-9490869974
MFCD00867593
MLS-0003109.0001
MLS000069648
MLS001076267
MolPort-002-345-613
N-(4-trifluoromethylphenyl)-5-methylisoxa-zole-4-carboxamide
N-(4-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide
N-(4-trifluoromethyphenyl)-5-methylisoxazole-4-carboxamide
N-(4'-Trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide
NCGC00015610-01
NCGC00015610-02
NCGC00015610-03
NCGC00015610-04
NCGC00015610-05
NCGC00015610-06
NCGC00015610-07
NCGC00015610-08
NCGC00015610-09
NCGC00015610-10
NCGC00015610-11
NCGC00015610-12
NCGC00015610-13
NCGC00015610-14
NCGC00015610-17
NCGC00015610-18
NCGC00022625-03
NCGC00022625-04
NCGC00022625-05
NCGC00022625-06
NCGC00022625-07
NCGC00022625-08
NCGC00255370-01
NCGC00261334-01
NINDS_000916
NSC-677411
NSC-759864
NSC677411
NSC759864
Opera_ID_1709
Pharmakon1600-01503927
Prestwick_87
Prestwick0_000772
Prestwick1_000772
Prestwick2_000772
Prestwick3_000772
Q-201289
R3926
Repso
RP29613
RS-34821
s1247
SC-46541
SCHEMBL5057
SMR000058209
SPBio_002783
Spectrum_000322
SPECTRUM1503927
Spectrum5_000850
SR-01000000191
SR-01000000191-2
ST079287
ST24047486
STL426823
SU 101
SU 101 (pharmaceutical)
SU-101
SU101
SULOL
TL8005179
Tox21_110182
Tox21_110182_1
Tox21_301873
Tox21_500649
UNII-G162GK9U4W
VHOGYURTWQBHIL-UHFFFAOYSA-N
ZB000596
ZINC4840

US Patents and Regulatory Information for leflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz LEFLUNOMIDE leflunomide TABLET;ORAL 077085-001 Sep 13, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alembic Pharms Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 091369-001 Nov 21, 2011 AB RX No 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 leflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Medtronic
US Department of Justice
McKesson
Citi
UBS
Mallinckrodt
Teva
Express Scripts

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