tirosint Drug Patent Profile
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When do Tirosint patents expire, and what generic alternatives are available?
Tirosint is a drug marketed by Ibsa and is included in two NDAs. There are five patents protecting this drug and five Paragraph IV challenges.
This drug has nineteen patent family members in nine countries.
The generic ingredient in TIROSINT 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
A generic version of tirosint was approved as levothyroxine sodium by MYLAN on June 5th, 2002.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for tirosint?
- What are the global sales for tirosint?
- What is Average Wholesale Price for tirosint?
Summary for tirosint
International Patents: | 19 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Clinical Trials: | 7 |
Patent Applications: | 2,565 |
Drug Prices: | Drug price information for tirosint |
Drug Sales Revenues: | Drug sales revenues for tirosint |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tirosint |
What excipients (inactive ingredients) are in tirosint? | tirosint excipients list |
DailyMed Link: | tirosint at DailyMed |
![tirosint drug patent expirations Drug patent expirations by year for tirosint](/p/graph/s/t/tirosint-patent-expirations.png)
![Drug Prices for tirosint](/p/graph/drug-price/tirosint.png)
![Drug Sales Revenue Trends for tirosint](/p/graph/drug-sales-revenues/tirosint.png)
Recent Clinical Trials for tirosint
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
Drug Class | l-Thyroxine |
Paragraph IV (Patent) Challenges for TIROSINT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIROSINT | Capsules | levothyroxine sodium | 137 mcg and 175 mcg | 021924 | 1 | 2022-11-04 |
TIROSINT | Capsules | levothyroxine sodium | 200 mcg | 021924 | 1 | 2021-12-30 |
TIROSINT | Capsules | levothyroxine sodium | 112 mcg | 021924 | 1 | 2020-12-18 |
TIROSINT | Capsules | levothyroxine sodium | 88 mcg, 100 mcg and 125 mcg | 021924 | 1 | 2019-08-01 |
TIROSINT | Capsules | levothyroxine sodium | 75 mcg and 150 mcg | 021924 | 1 | 2017-12-29 |
US Patents and Regulatory Information for tirosint
tirosint is protected by two US patents.
Patents protecting tirosint
Pharmaceutical formulae for thyroid hormones and procedures for obtaining them
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical formulations for thyroid hormones
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 206977-009 | Dec 15, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-002 | 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 | 206977-006 | Dec 15, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-015 | Jan 13, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for tirosint
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-009 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-004 | Oct 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-013 | Aug 1, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-006 | Oct 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-007 | Oct 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tirosint
See the table below for patents covering tirosint around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1433478 | Formes de dosage contenant des hormones thyroidiennes et procédé de préparation de ces formes (Pharmaceutical formulae for thyroid hormones and procedures for obtaining them) | ⤷ Sign Up |
Austria | 312621 | ⤷ Sign Up | |
Spain | 2254559 | ⤷ Sign Up | |
Japan | 4851064 | ⤷ Sign Up | |
Denmark | 1291021 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tirosint
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1291021 | 132012902104794 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |