TIROSINT-SOL Drug Patent Profile

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Which patents cover Tirosint-sol, and when can generic versions of Tirosint-sol launch?

Tirosint-sol is a drug marketed by Institut Biochimique and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in eleven countries.

The generic ingredient in TIROSINT-SOL is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-six 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 5^th, 2002.

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Summary for TIROSINT-SOL

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	7
Patent Applications:	3,756
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIROSINT-SOL
DailyMed Link:	TIROSINT-SOL at DailyMed

Drug patent expirations by year for TIROSINT-SOL

Recent Clinical Trials for TIROSINT-SOL

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

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Pharmacology for TIROSINT-SOL

Drug Class	l-Thyroxine

Anatomical Therapeutic Chemical (ATC) Classes for TIROSINT-SOL

H03AA	Thyroid hormones
H03A	THYROID PREPARATIONS
H03	THYROID THERAPY
H	Systemic hormonal preparations, excluding sex hormones and insulins

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 two US patents.

Patents protecting TIROSINT-SOL

High-stability packaged solutions of T4 thyroid hormone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Glossary

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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	206977-011	Dec 15, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Institut Biochimique	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Institut Biochimique	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-001	Dec 15, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Institut Biochimique	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-006	Dec 15, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3311844	SOLUTIONS EMBALLÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)	⤷ Try a Trial
Denmark	3528847		⤷ Try a Trial
Hungary	E052092		⤷ Try a Trial
Slovenia	3528847		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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