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Last Updated: December 1, 2021

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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 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 thirteen 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
Zhejiang Provincial Hospital of TCMPhase 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
⤷  Try it Free⤷  Try it Free200MCG/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 076187-008 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-007 Dec 15, 2016 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amneal LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-003 Feb 19, 2019 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-010 Mar 1, 2002 ⤷  Try it Free ⤷  Try it Free
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-007 Mar 1, 2002 ⤷  Try it Free ⤷  Try it Free
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-008 Mar 1, 2002 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for levothyroxine sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1291021 132012902104794 Italy ⤷  Try it Free 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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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 verification 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.