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Last Updated: August 8, 2020

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TIROSINT Drug 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 three patents protecting this drug and one Paragraph IV challenge.

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. Thirty-nine suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

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

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SponsorPhase
IBSA Institut Biochimique SAPhase 4
Meyer Children's HospitalPhase 4
Charite University, Berlin, GermanyN/A

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Paragraph IV (Patent) Challenges for TIROSINT
Tradename Dosage Ingredient NDA Submissiondate
TIROSINT CAPSULE;ORAL levothyroxine sodium 021924 2019-08-01
TIROSINT CAPSULE;ORAL levothyroxine sodium 021924 2017-12-29

US Patents and Regulatory Information for TIROSINT

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 206977-008 Dec 15, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-004 Dec 15, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-009 Dec 15, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TIROSINT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1291021 132012902104794 Italy   Start Trial 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:

Medtronic
AstraZeneca
Express Scripts
Merck
McKinsey
Mallinckrodt

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