DrugPatentWatch Database Preview
LEVOTHYROXINE SODIUM - Generic Drug Details
What are the generic drug sources for levothyroxine sodium and what is the scope of patent protection?
Levothyroxine sodium
is the generic ingredient in ten branded drugs marketed by Institut Biochimique, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Provell, Cediprof Inc, Genus Lifesciences, Amneal Pharms Llc, Lupin Atlantis, Merck Kgaa, Mylan, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in eighteen NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Levothyroxine sodium has fifty-seven patent family members in sixteen countries.
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.
Summary for LEVOTHYROXINE SODIUM
| International Patents: | 57 |
| US Patents: | 11 |
| Tradenames: | 10 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 143 |
| Clinical Trials: | 16 |
| Patent Applications: | 7,144 |
| 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 |
Recent Clinical Trials for LEVOTHYROXINE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Phase 1 |
| Tecnoquimicas | Phase 4 |
| University of California, Irvine | N/A |
Recent Litigation for LEVOTHYROXINE SODIUM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. | 2018-04-13 |
| Fresenius Kabi USA, LLC v. Dr. Reddys Laboratories, Inc. | 2016-06-09 |
| Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc. | 2016-06-09 |
See all LEVOTHYROXINE SODIUM litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Institutional Inc. | 2017-01-19 |
Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 200MCG/VIAL | POWDER;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 202231-001 | Jun 24, 2011 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Abbvie | SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402-005 | Jul 24, 2002 | AB1,AB2 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-003 | May 25, 2001 | AB1,AB3 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Fresenius Kabi Usa | LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 202231-001 | Jun 24, 2011 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Merck Kgaa | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076752-011 | Jun 16, 2005 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Provell | EUTHYROX | levothyroxine sodium | TABLET;ORAL | 021292-009 | May 31, 2002 | AB2 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LEVOTHYROXINE SODIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2440190 | Start Trial |
| European Patent Office | 1474103 | Start Trial |
| Italy | MI20022777 | Start Trial |
| Brazil | 0109736 | Start Trial |
| Canada | 2438907 | Start Trial |
| Spain | 2334777 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
Copyright 2002-2019 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.