TIROSINT-SOL Drug Patent Profile

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-one 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. Forty-eight 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.

Summary for TIROSINT-SOL

International Patents:	21
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	7
Patent Applications:	3,229
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIROSINT-SOL
DailyMed Link:	TIROSINT-SOL at DailyMed

See drug prices 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

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 four US patents.

Patents protecting TIROSINT-SOL

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
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-005	Dec 15, 2016		RX	Yes	No			Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-010	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes			Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-009	Dec 15, 2016		RX	Yes	No

International Patents for TIROSINT-SOL

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

Country	Patent Number	Title	Estimated Expiration
Canada	3129627	REGIME D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROIDIENNE T4 A ABSORPTION ORALE ELEVEE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION)
China	113645966	口服吸收高的T4甲状腺激素溶液的给药方案 (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION)
European Patent Office	3930703	RÉGIME D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION)
Morocco	55071	RÉGIME D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE
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)