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Last Updated: April 13, 2024

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, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva. and is included in eighteen 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-eight 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

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

SponsorPhase
Xeris PharmaceuticalsPhase 2
CromsourcePhase 4
University of California, Los AngelesPhase 4

See all LEVOTHYROXINE SODIUM clinical trials

Pharmacology for LEVOTHYROXINE SODIUM
Drug Classl-Thyroxine
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
THYQUIDITY Oral Solution levothyroxine sodium 100 mcg/5 mL 214047 1 2022-12-28
TIROSINT Capsules levothyroxine sodium 137 mcg and 175 mcg 021924 1 2022-11-04
TIROSINT-SOL Oral Solution levothyroxine sodium 13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL 206977 1 2022-09-30
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
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Patent Expiration: ⤷  Try a Trial

Levothyroxine liquid formulations
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Stabilized liquid formulation of levothyroxine
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Patent Expiration: ⤷  Try a Trial

Levothyroxine formulations
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Levothyroxine formulations
Patent Number: ⤷  Try a Trial
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Levothyroxine formulations
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Levothyroxine liquid formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascent Pharms Inc LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 215259-010 Jan 18, 2023 AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Kgaa LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076752-003 Jun 16, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-003 Oct 19, 2020 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-002 Apr 11, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-012 Jan 18, 2019 AB1,AB2,AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-005 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-011 Oct 19, 2020 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2017013591 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013033194 ⤷  Try a Trial
Canada 3045794 FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018102145 ⤷  Try a Trial
European Patent Office 2750664 FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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