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Last Updated: October 26, 2021

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LEVOTHYROXINE SODIUM - Generic Drug Details

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

Levothyroxine sodium is the generic ingredient in eleven branded drugs marketed by Teva Pharms Usa Inc, Institut Biochimique, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Custopharm Inc, Vistapharm, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, Mylan, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-four NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levothyroxine sodium has seventy-two patent family members in twenty-three countries.

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

Drug Sales Revenue Trends for LEVOTHYROXINE SODIUM

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Recent Clinical Trials for LEVOTHYROXINE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, Los AngelesPhase 4
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
First People's Hospital of HangzhouPhase 4

See all LEVOTHYROXINE SODIUM clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial200MCG/VIALPOWDER;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 Classl-Thyroxine
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
TIROSINT CAPSULE;ORAL levothyroxine sodium 021924 2020-12-18
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
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-011 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-002 Oct 24, 2002 AB2,AB4 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dr Reddys LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 208837-001 Mar 27, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-002 Mar 1, 2002 AB1,AB2,AB3 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-003 Feb 19, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-012 Dec 8, 2003 AB1,AB2,AB3 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Institut Biochimique TIROSINT levothyroxine sodium CAPSULE;ORAL 021924-008 Oct 2, 2009 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEVOTHYROXINE SODIUM

International Patents for LEVOTHYROXINE SODIUM

Country Patent Number Estimated Expiration
Japan 2005517720 ⤷  Free Forever Trial
Australia 2002332507 ⤷  Free Forever Trial
European Patent Office 1365745 ⤷  Free Forever Trial
Japan 2004525109 ⤷  Free Forever Trial
Brazil 0207299 ⤷  Free Forever Trial
Portugal 2683361 ⤷  Free Forever Trial
Italy MI20011401 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for LEVOTHYROXINE SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1291021 132012902104794 Italy ⤷  Free Forever Trial PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Merck
Dow
Mallinckrodt
McKinsey

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