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Generated: September 23, 2018

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Levothyroxine sodium - Generic Drug Details

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

Levothyroxine sodium is the generic ingredient in ten branded drugs marketed by Institut Biochimique, Fresenius Kabi Usa, Par Sterile Products, Piramal Critical, Cediprof Inc, Genus Lifesciences, Merck Kgaa, Mylan, King Pharms, Abbvie, Lloyd, and Stevens J, and is included in fourteen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for levothyroxine sodium. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for levothyroxine sodium
Ingredient-typeThyroxine
Drug Classl-Thyroxine
Synonyms for levothyroxine sodium
(-)-Thyroxine
(-)-Thyroxine Sodium
(125I)T4
(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodo-phenoxy)-3,5-diiodo-phenyl]propanoic acid
(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic aci d, sodium salt
(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid
(S)-2-amino-3-(4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)propanoic acid
(S)-2-Amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propionic Acid Sodium Salt
002T595
054I36CPMN
137-53-1
1hk1
1hk2
1hk3
1hk4
1hk5
1y0x
2-amino-3-[4-(4-hydroxy-3,5-diiodo-phenoxy)-3,5-diiodo-phenyl]-propanoic acid
24486-40-6
25416-65-3
2ceo
3-(4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)alanine
3-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]-L-alanine
3,3?,5,5?-Tetraiodo-L-thyronine sodium salt
3,3',5,5'-Tetraiodo-L-thyronine
3,3',5,5'-Tetraiodo-L-thyronine Sodium
3,3',5,5'-Tetraiodo-L-thyronine sodium salt
3,3',5,5'-Tetraiodo-L-thyronine, sodium salt
3,3',5,5''-Tetraiodo-L-thyronine
3,3',5,5"-Tetraiodo-L-thyronine
3,3'',5,5''-tetraiodo-L-thyronine
3,5,3',5'-Tetraiodo-L-thyronine
3,5,3',5'-Tetraiodothyronine
3,5,3'',5''-tetraiodo-L-thyronine
3,5,3'5'-Tetraiodo-L-thyronine
4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodo-L-phenylalanine
50809-32-0
51-48-9
55-03-8
587-29-1
587-30-4
60833-83-2
6260AF
67809-22-7
7200-84-2
74-16-8
7488-70-2
7U4LEE5872
A830452
AB00052176_09
AB00052176_10
AB00052176-08
AB0010528
AB2000689
AC-10210
AC-10465
AC-7504
AC-919
AC1L1L7K
AK-40208
AK-46618
AKOS015905129
AKOS015918420
AKOS024284731
AM006672
AM016770
AM83594
AN-15421
AN-8921
API0007805
AX8015809
BBC/815
BC204258
BC630681
BDBM50301375
Berlthyrox
beta-((3,5-Diiodo-4-hydroxyphenoxy)-3,5-diiodophenyl)alanine
BIDD:PXR0161
bmse000923
BPBio1_000360
BRD-K30685142-001-05-5
BRN 2228515
BSPBio_000326
BSPBio_002142
C01829
C08212
C15H10I4NO4.Na
C15H11I4NO4
CAS-51-48-9
CCG-38738
CCRIS 6739
CHEBI:18332
CHEBI:6446
CHEMBL1624
CHM0030272
CPD000059176
CS-1819
CT-230
CT-452
CTK2H7538
CTK4J3191
D-3,5-Diiodo-4-(3',5'-Diiodo-4'-hydroxyphenoxy)-phenylalanine sodium salt
D06RGG
D08125
Dathroid
DB-006261
DB00451
DivK1c_006967
DL-Thyroxin
DSSTox_CID_3214
DSSTox_GSID_23214
DSSTox_RID_76927
DTXSID8023214
EBD2201200
Eferox
EINECS 200-101-1
EINECS 200-221-4
eltroxin
Eltroxin (TN)
Epitope ID:123889
Epitope ID:136776
Euthyrox
Euthyrox (TN)
Eutirox
Eutirox (TN)
Forthyron
Forthyron (TN)
FT-0600821
FT-0628030
FT-0658959
GP9966
GTPL2635
Henning
Henning Sodium
HMS1569A08
HMS1921I06
HMS2090P18
HMS2092K12
HMS2096A08
HMS2233J18
HMS3259M11
HSDB 3108
HY-18341
I14-8105
J-524276
J10324
KB-53412
KBio1_001911
KBio2_001556
KBio2_004124
KBio2_006692
KBio3_001642
KBioGR_000516
KBioSS_001556
KS-00000F9R
KS-00000HDI
L-3,5,3',5'-Tetraiodothyronine
L-T4
L-T4 Sodium
L-Thryoxin
L-Thyroxin
L-Thyroxin Sodium
L-thyroxine
L-Thyroxine (T4) solution, 100 mug/mL in methanol with 0.1N NH3, ampule of 1 mL, certified reference material
L-thyroxine (TN)
l-Thyroxine monosodium salt
L-Thyroxine sodium
L-Thyroxine sodium salt
L-Thyroxine, >=98% (HPLC)
L-Thyroxine, free acid
L-Thyroxine, powder, BioReagent, suitable for cell culture
L-Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-
L-Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, monosodium salt
L-Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, monosodium salt, hydrate (9CI)
L-Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, sodium salt (1:1)
Laevothyroxinum
Laevothyroxinum (acid)
Laevoxin
Letter
Levaxin
Levaxin (TN)
Leventa
Levo-T
Levolet
Levoroxine
levothroid
Levothroid (*Sodium salt*)
Levothroid (*Sodiumsalt*)
Levothyrox
Levothyroxin
levothyroxin natrium
Levothyroxin-natrium
levothyroxine
Levothyroxine (BAN)
Levothyroxine [INN]
Levothyroxine sodique
Levothyroxine sodique [INN-French]
Levothyroxine Sodium (anhydrous)
Levothyroxine Sodium (L-thyroxine)
Levothyroxine Sodium [USAN:INN]
Levothyroxine Sodium [USAN]
Levothyroxine sodium anhydrous
levothyroxine sodium pentahydrate
Levothyroxine sodium tablets
Levothyroxine, pharmaceutical secondary standard; traceable to USP, PhEur
Levothyroxine, United States Pharmacopeia (USP) Reference Standard
Levothyroxinum
Levothyroxinum (acid)
Levothyroxinum natricum
Levothyroxinum natricum [INN-Latin]
levotiroxina de sodio
Levotiroxina sodica
Levotiroxina sodica [INN-Spanish]
Levoxyl
Levoxyl (TN)
LS-153817
LS-153822
LS-158291
LT00440967
LT4
MFCD00002595
MLS000028647
MLS002548901
MolPort-002-511-861
MolPort-003-666-820
Monosodium L-thyroxine
NC00485
NCGC00094852-03
NCGC00164336-01
NCGC00164336-02
NCGC00164336-03
NCGC00164336-05
NCGC00255368-01
Novothyrox
NSC 259940
NSC 36397
NSC 36397-Sodium
NSC-757434
NSC757434
O-(4-Hydroxy-3,5-diidophenyl)-3,5-diiodo-L-tyrosine
O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine
O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine Sodium
O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine
Oroxine
Pharmakon1600-01500774
Prestwick_548
Prestwick0_000403
Prestwick1_000403
Prestwick2_000403
Prestwick3_000403
Q51BO43MG4
RL03895
RL04067
Ro-thyroxine
Roxstan
s2599
SAM002264651
SBI-0051608.P002
SCHEMBL23098
SCHEMBL34102
SDCCGMLS-0066571.P001
SMR000059176
sodium (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate
sodium (2S)-2-azanyl-3-[4-[3,5-bis(iodanyl)-4-oxidanyl-phenoxy]-3,5-bis(iodanyl)phenyl]propanoate
Sodium (S)-2-Amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propionate
sodium 4-o-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-l-tyrosine
Sodium l-thyroxin
Sodium L-thyroxine
Sodium levothyroxine
SODIUM LEVOTHYROXINE(1-)
Sodium thyroxin
Sodium thyroxinate
Sodium thyroxine
Sodium-L-thyroxine
Sodiumlevothyroxine
Soloxine
SPBio_000386
SPBio_002265
SpecPlus_000871
Spectrum_001076
SPECTRUM1500774
Spectrum2_000573
Spectrum3_000611
Spectrum4_000128
Spectrum5_001500
ST078859
ST24047479
STOCK1N-15023
synthroid
Synthroid (*Sodium salt*)
Synthroid (TN)
Synthroid sodium
T-3850
t4
T4 (Hormone)
T4 levothyroxine
T4 Sodium
T44
Tetraiodothyronine
Tetramet
Tetroid
Thevier
Thryroxine, l-
THX
Thyradin
Thyradin S
Thyratabs
Thyrax
Thyrax (TN)
Thyrax Sodium
Thyreoideum
Thyreoideum Sodium
Thyro-Tabs
THYROID
Thyronamin
Thyrosit
Thyrox (TN)
Thyroxevan
thyroxin
Thyroxin sodium
Thyroxinal
Thyroxinal Sodium
thyroxine
Thyroxine (l)
Thyroxine (T4), IRMM(R) certified Reference Material
Thyroxine (VAN)
Thyroxine [BAN]
Thyroxine I 125
Thyroxine iodine
Thyroxine sodique
Thyroxine sodium
Thyroxine sodium salt
Thyroxine, L-
Thyroxine, L- (8CI)
Thyroxine, L-(8CI)
Thyroxine, labeled with iodine-125
Thyroxine, monosodium salt, L-
Thyroxinique
Thyroxinum natricum
Tiroidina
Tirosint
Tirosint-Sol
Tox21_112101
Tox21_112101_1
Tox21_302156
TR-031344
Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, labeled with iodine-125
Tyrosint
UNII-054I36CPMN
UNII-7U4LEE5872
UNII-Q51BO43MG4
UNII-QR0BV3BRIA component XUIIKFGFIJCVMT-LBPRGKRZSA-N
Unithroid
XUIIKFGFIJCVMT-LBPRGKRZSA-N
YDTFRJLNMPSCFM-YDALLXLXSA-M
Z2798529463
ZINC3830993
Tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
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US Patents and Regulatory Information for levothyroxine sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Institut Biochimique TIROSINT levothyroxine sodium CAPSULE;ORAL 021924-011 Apr 25, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-003 Jul 24, 2002 AB1,AB2 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-011 Jul 24, 2002 AB1,AB2 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-005 Jun 5, 2002 AB1,AB2,AB3,AB4 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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Merck
Chinese Patent Office
Chubb
Teva
Medtronic
Johnson and Johnson
Federal Trade Commission

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.