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 Ibsa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-one 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.
Summary for TIROSINT-SOL
International Patents: | 21 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 7 |
Patent Applications: | 3,229 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TIROSINT-SOL |
DailyMed Link: | TIROSINT-SOL at DailyMed |
Recent Clinical Trials for TIROSINT-SOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cromsource | Phase 4 |
University of California, Los Angeles | Phase 4 |
Children's Mercy Hospital Kansas City | Phase 4 |
Pharmacology for TIROSINT-SOL
Drug Class | l-Thyroxine |
Anatomical Therapeutic Chemical (ATC) Classes for TIROSINT-SOL
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: ⤷ 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
Administration regimen of compositions of T4 thyroid hormone with high oral absorption
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-005 | Dec 15, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-010 | Dec 15, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-012 | Dec 15, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-009 | Dec 15, 2016 | RX | Yes | 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 TIROSINT-SOL
See the table below for patents covering TIROSINT-SOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Morocco | 55071 | RÉGIME D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2020178074 | ⤷ Try a Trial | |
Canada | 3037808 | SOLUTIONS CONDITIONNEES A STABILITE ELEVEE D'HORMONE THYROIDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE) | ⤷ Try a Trial |
Russian Federation | 2019106889 | ВЫСОКОСТАБИЛЬНЫЕ УПАКОВАННЫЕ РАСТВОРЫ ТИРЕОИДНОГО ГОРМОНА Т4 | ⤷ Try a Trial |
Russian Federation | 2765547 | ВЫСОКОСТАБИЛЬНЫЕ УПАКОВАННЫЕ РАСТВОРЫ ТИРЕОИДНОГО ГОРМОНА Т4 (HIGHLY STABLE PACKAGED SOLUTIONS OF THE THYROID HORMONE T4) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |