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LEVOTHYROXINE SODIUM Drug Profile

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When do Levothyroxine Sodium patents expire, and what generic alternatives are available?

Levothyroxine Sodium is a drug marketed by Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Amneal Pharms Llc, Lupin Atlantis, Merck Kgaa, and Mylan. and is included in nine NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has four patent family members in three countries.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for LEVOTHYROXINE SODIUM

International Patents:	4
US Patents:	5
Applicants:	8
NDAs:	9
Suppliers / Packagers:	14
Bulk Api Vendors:	143
Clinical Trials:	17
Patent Applications:	4,224
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for LEVOTHYROXINE SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOTHYROXINE SODIUM
DailyMed Link:	LEVOTHYROXINE SODIUM at DailyMed

See drug sales revenues for LEVOTHYROXINE SODIUM

Recent Clinical Trials for LEVOTHYROXINE SODIUM

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Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
First People's Hospital of Hangzhou	Phase 4
Zhejiang Provincial Hospital of TCM	Phase 4

See all LEVOTHYROXINE SODIUM clinical trials

Recent Litigation for LEVOTHYROXINE SODIUM

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District Court Litigation

Case Name	Date
IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc.	2018-04-13
Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc.	2016-06-09
Fresenius Kabi USA, LLC v. Dr. Reddys Laboratories, Inc.	2016-06-09

See all LEVOTHYROXINE SODIUM litigation

PTAB Litigation

Petitioner	Date
Mylan Institutional Inc.	2017-01-19

See all LEVOTHYROXINE SODIUM litigation

Pharmacology for LEVOTHYROXINE SODIUM

Drug Class

l-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

1373931-44-2

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

3,5,3',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

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

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

BRD-K30685142-001-08-9

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

D08125

D11113

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

Epitope ID:123889

Epitope ID:136776

Euthyrox

Eutirox

Forthyron (TN)

FT-0600821

FT-0628030

FT-0658959

GP9966

GTPL2635

Henning

Henning Sodium

HMS1569A08

HMS1921I06

HMS2090P18

HMS2092K12

HMS2096A08

HMS2233J18

HMS3259M11

HMS3713A08

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 monosodium salt

L-Thyroxine sodium

L-Thyroxine sodium salt

L-Thyroxine, >=98% (HPLC)

L-Thyroxine, 97+%

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-, monosodiumsalt

L-Tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, sodium salt (1:1)

Laevothyroxinum

Laevothyroxinum (acid)

Laevoxin

Letter

Levaxin

Leventa

Levo-T

Levolet

Levoroxine

levothroid

Levothroid (*Sodium salt*)

Levothyrox

Levothyroxin

Levothyroxin-natrium

levothyroxine

Levothyroxine (BAN)

Levothyroxine [INN:BAN]

Levothyroxine sodique

Levothyroxine sodique [INN-French]

Levothyroxine Sodium (anhydrous)

Levothyroxine sodium (INN)

Levothyroxine Sodium (L-thyroxine)

Levothyroxine Sodium [USAN:INN]

Levothyroxine Sodium [USAN]

Levothyroxine sodium anhydrous

Levothyroxine sodium tablets

Levothyroxine, Pharmaceutical Secondary Standard; Certified Reference Material

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

LS-153817

LS-153822

LS-158291

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

NCGC00164336-06

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 thyroxin

Sodium thyroxinate

Sodium thyroxine

Sodium-L-thyroxine

Soloxine

SPBio_000386

SPBio_002265

SpecPlus_000871

Spectrum_001076

SPECTRUM1500774

Spectrum2_000573

Spectrum3_000611

Spectrum4_000128

Spectrum5_001500

SR-01000759430

SR-01000759430-2

SR-05000001567

SR-05000001567-1

ST078859

ST24047479

SW196731-3

synthroid

Synthroid (*Sodium salt*)

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 Sodium

Thyreoideum

Thyreoideum Sodium

Thyro-Tabs

THYROID

Thyronamin

Thyrosit

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, 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

Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
TIROSINT	CAPSULE;ORAL	levothyroxine sodium	021924	2019-08-01
TIROSINT	CAPSULE;ORAL	levothyroxine sodium	021924	2017-12-29
LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	levothyroxine sodium	202231	2015-05-01
LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	levothyroxine sodium	202231	2015-04-14
LEVOXYL	TABLET;ORAL	levothyroxine sodium	021301

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
Lupin Atlantis	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	209713-008	Jan 18, 2019	AB1,AB2	RX	No	No
Amneal Pharms Llc	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	210831-011	Feb 19, 2019		DISCN	No	No
Merck Kgaa	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076752-004	Jun 16, 2005		DISCN	No	No

International Patents for LEVOTHYROXINE SODIUM

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013033194
World Intellectual Property Organization (WIPO)	2018102145
European Patent Office	2750664