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.
Summary for TIROSINT-SOL
International Patents: | 13 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 7 |
Patent Applications: | 3,756 |
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 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 |