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Last Updated: June 29, 2022

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 Institut Biochimique and is included in two NDAs. There are four patents protecting this drug and four 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 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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Drug patent expirations by year for TIROSINT
Drug Prices for TIROSINT

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Drug Sales Revenue Trends for TIROSINT

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Recent Clinical Trials for TIROSINT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CromsourcePhase 4
University of California, Los AngelesPhase 4
Children's Mercy Hospital Kansas CityPhase 4

See all TIROSINT clinical trials

Paragraph IV (Patent) Challenges for TIROSINT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations for thyroid hormones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 206977-006 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-014 Jan 13, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-010 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-008 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-010 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-002 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-003 Dec 15, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

See the table below for patents covering TIROSINT around the world.

Country Patent Number Title Estimated Expiration
Japan 5105685 See Plans and Pricing
Spain 2254559 See Plans and Pricing
European Patent Office 1291021 Formulations pharmaceutiques comprenant des hormones thyroidiennes (Pharmaceutical formulations for thyroid hormones) See Plans and Pricing
Austria 312621 See Plans and Pricing
Italy MI20011401 See Plans and Pricing
Japan 4851064 See Plans and Pricing
Canada 2454050 PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES ET PROCEDES POUR OBTENIR CELLES-CI (PHARMACEUTICAL FORMULAE FOR THYROID HORMONES AND PROCEDURES FOR OBTAINING THEM) See Plans and Pricing
>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 See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

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Express Scripts
Merck
McKinsey
Mallinckrodt

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