TIROSINT-SOL Drug Patent Profile
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When do Tirosint-sol patents expire, and what generic alternatives are available?
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. Fifty-one 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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Summary for TIROSINT-SOL
| International Patents: | 22 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,016 |
| Drug Prices: | Drug price information for TIROSINT-SOL |
| DailyMed Link: | TIROSINT-SOL at DailyMed |
Recent Clinical Trials for TIROSINT-SOL
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| 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 |
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 | ||||
| >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
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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.
ISSN: 2162-2639
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