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Last Updated: June 7, 2023

TIROSINT-SOL Drug Patent Profile


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Which patents cover Tirosint-sol, and when can generic versions of Tirosint-sol launch?

Tirosint-sol is a drug marketed by Institut Biochimique and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in eleven countries.

The generic ingredient in TIROSINT-SOL is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tirosint-sol

A generic version of TIROSINT-SOL was approved as levothyroxine sodium by MYLAN on June 5th, 2002.

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Drug patent expirations by year for TIROSINT-SOL
Drug Prices for TIROSINT-SOL

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Recent Clinical Trials for TIROSINT-SOL

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SponsorPhase
CromsourcePhase 4
University of California, Los AngelesPhase 4
Children's Mercy Hospital Kansas CityPhase 4

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Pharmacology for TIROSINT-SOL
Drug Classl-Thyroxine
Paragraph IV (Patent) Challenges for TIROSINT-SOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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

US Patents and Regulatory Information for TIROSINT-SOL

TIROSINT-SOL is protected by two US patents.

Patents protecting TIROSINT-SOL

High-stability packaged solutions of T4 thyroid hormone
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

High-stability packaged solutions of T4 thyroid hormone
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
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-011 Dec 15, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-012 Dec 15, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-001 Dec 15, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-006 Dec 15, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 TIROSINT-SOL

See the table below for patents covering TIROSINT-SOL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3311844 SOLUTIONS EMBALLÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE) ⤷  Try a Trial
Denmark 3528847 ⤷  Try a Trial
Hungary E052092 ⤷  Try a Trial
Slovenia 3528847 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.