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 Ibsa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in thirteen countries.

The generic ingredient in TIROSINT-SOL 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-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:	22
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	7
Patent Applications:	3,016
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

See all TIROSINT-SOL clinical trials

Pharmacology for TIROSINT-SOL

Drug Class	l-Thyroxine

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 four US patents.

Patents protecting TIROSINT-SOL

High-stability packaged solutions of T4 thyroid hormone
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Patent Expiration: ⤷ Sign Up

Administration regimen of compositions of T4 thyroid hormone with high oral absorption
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPOTHYROIDISM BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST

Administration regimen of compositions of T4 thyroid hormone with high oral absorption
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Patented Use: TREATMENT OF PITUITARY THYROTROPIN SUPPRESSION BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST

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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
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-008	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-005	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-010	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	206977-009	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-011	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-004	Dec 15, 2016		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

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
Poland	3528847		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020178074		⤷ Sign Up
Portugal	3930703		⤷ Sign Up
Hungary	E052092		⤷ Sign Up
European Patent Office	3528847	SOLUTIONS CONDITIONNÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)	⤷ Sign Up
Spain	2824787		⤷ Sign Up
China	109789213	T4甲状腺激素的高稳定性包装解决方案 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration