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Last Updated: October 26, 2021

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LEVOTHYROXINE SODIUM Drug Patent Profile


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

Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Custopharm Inc, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, and Mylan. and is included in fourteen 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Levothyroxine Sodium

A generic version of LEVOTHYROXINE SODIUM was approved as levothyroxine sodium by MYLAN on June 5th, 2002.

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Drug patent expirations by year for LEVOTHYROXINE SODIUM
Drug Sales Revenue Trends for LEVOTHYROXINE SODIUM

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Recent Clinical Trials for LEVOTHYROXINE SODIUM

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SponsorPhase
University of California, Los AngelesPhase 4
Zhejiang Provincial Hospital of TCMPhase 4
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4

See all LEVOTHYROXINE SODIUM clinical trials

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
Merck Kgaa LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076752-007 Jun 16, 2005 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-012 Oct 19, 2020 AB2 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-003 Oct 19, 2020 AB2 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-009 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-008 Feb 19, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  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

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Moodys
Colorcon
McKinsey
Merck

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