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Last Updated: August 17, 2022

LEVOTHYROXINE SODIUM Drug Patent Profile


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Which patents cover Levothyroxine Sodium, and when can generic versions of Levothyroxine Sodium launch?

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, Mylan, and Watson Labs Teva. and is included in fifteen NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has five 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 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
CromsourcePhase 4
University of California, Los AngelesPhase 4
Zhejiang Provincial Hospital of TCMPhase 4

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Pharmacology for LEVOTHYROXINE SODIUM
Drug Class l-Thyroxine
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIROSINT Capsules levothyroxine sodium 200 mcg 021924 1 2021-12-30
TIROSINT Capsules levothyroxine sodium 112 mcg 021924 1 2020-12-18
TIROSINT Capsules levothyroxine sodium 88 mcg, 100 mcg and 125 mcg 021924 1 2019-08-01
TIROSINT Capsules levothyroxine sodium 75 mcg and 150 mcg 021924 1 2017-12-29
LEVOTHYROXINE SODIUM for Injection levothyroxine sodium 200 mcg/vial 202231 1 2015-05-01
LEVOTHYROXINE SODIUM for Injection levothyroxine sodium 100 mcg/vial and 500 mcg/vial 202231 2 2015-04-14

US Patents and Regulatory Information for LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM is protected by seven US patents.

Patents protecting LEVOTHYROXINE SODIUM

Levothyroxine liquid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Levothyroxine liquid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized liquid formulation of levothyroxine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Levothyroxine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Levothyroxine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Levothyroxine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Levothyroxine liquid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 076752-004 Jun 16, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs Teva LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 207588-010 May 10, 2022 AB1,AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-009 Oct 19, 2020 AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

See the table below for patents covering LEVOTHYROXINE SODIUM around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2018102145 See Plans and Pricing
European Patent Office 2750664 FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS) See Plans and Pricing
Canada 3045794 FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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.