TIROSINT Drug Patent Profile
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When do Tirosint patents expire, and when can generic versions of Tirosint launch?
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. 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
A generic version of TIROSINT was approved as levothyroxine sodium by MYLAN on June 5th, 2002.
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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 |
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 | 021924-004 | 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 | 021924-008 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-002 | Oct 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924-005 | 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 |
|---|---|---|---|
| Japan | 2004210780 | PHARMACEUTICAL FORMATION FOR THYROID HORMONE AND METHOD FOR OBTAINING THE SAME | ⤷ Sign Up |
| Italy | MI20022777 | FORMULAZIONI FARMACEUTICHE PER ORMONI TIROIDEI E PROCEDIMENTI PER IL LORO OTTENIMENTO. | ⤷ Sign Up |
| 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 |
| Spain | 2334777 | ⤷ Sign Up | |
| Canada | 2454050 | PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES ET PROCEDES POUR OBTENIR CELLES-CI (PHARMACEUTICAL FORMULAE FOR THYROID HORMONES AND PROCEDURES FOR OBTAINING THEM) | ⤷ 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 |
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.
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