You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 15, 2024

TIROSINT-SOL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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

This drug has twenty-two patent family members in thirteen countries.

The generic ingredient in TIROSINT-SOL 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 Tirosint-sol

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

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for TIROSINT-SOL?
  • What are the global sales for TIROSINT-SOL?
  • What is Average Wholesale Price for TIROSINT-SOL?
Drug patent expirations by year for TIROSINT-SOL
Drug Prices for TIROSINT-SOL

See drug prices for TIROSINT-SOL

Recent Clinical Trials for TIROSINT-SOL

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

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

See all TIROSINT-SOL clinical trials

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 four US patents.

Patents protecting TIROSINT-SOL

High-stability packaged solutions of T4 thyroid hormone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

High-stability packaged solutions of T4 thyroid hormone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Administration regimen of compositions of T4 thyroid hormone with high oral absorption
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPOTHYROIDISM BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST

Administration regimen of compositions of T4 thyroid hormone with high oral absorption
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PITUITARY THYROTROPIN SUPPRESSION BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-008 Dec 15, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-005 Dec 15, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-010 Dec 15, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-012 Dec 15, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-009 Dec 15, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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) ⤷  Sign Up
European Patent Office 4321214 SCHÉMA D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION) ⤷  Sign Up
Portugal 3528847 ⤷  Sign Up
Spain 2824787 ⤷  Sign Up
Poland 3528847 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.