TIROSINT Drug Patent Profile

When do Tirosint patents expire, and when can generic versions of Tirosint launch?

Tirosint is a drug marketed by Ibsa and is included in two NDAs. There are five patents protecting this drug and five 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-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

A generic version of TIROSINT was approved as levothyroxine sodium by MYLAN on June 5^th, 2002.

Summary for TIROSINT

International Patents:	19
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	7
Patent Applications:	2,565
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIROSINT
Drug Sales Revenues:	Drug sales revenues for TIROSINT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROSINT
What excipients (inactive ingredients) are in TIROSINT?	TIROSINT excipients list
DailyMed Link:	TIROSINT at DailyMed

See drug prices for TIROSINT

See drug sales revenues for TIROSINT

Recent Clinical Trials for TIROSINT

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 clinical trials

Pharmacology for TIROSINT

Drug Class

l-Thyroxine

Anatomical Therapeutic Chemical (ATC) Classes for TIROSINT

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

Paragraph IV (Patent) Challenges for TIROSINT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
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

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	206977-009	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-002	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	206977-006	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-015	Jan 13, 2021		RX	Yes	No			Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-004	Dec 15, 2016		RX	Yes	No			Y

Expired US Patents for TIROSINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-006	Oct 13, 2006

International Patents for TIROSINT

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

Country	Patent Number	Title	Estimated Expiration
Japan	5105685
Austria	312621
Canada	2392545	PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES (PHARMACEUTICAL FORMULATIONS FOR THYROID HORMONES)
Canada	2454050	PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES ET PROCEDES POUR OBTENIR CELLES-CI (PHARMACEUTICAL FORMULAE FOR THYROID HORMONES AND PROCEDURES FOR OBTAINING THEM)
European Patent Office	1291021	Formulations pharmaceutiques comprenant des hormones thyroidiennes (Pharmaceutical formulations for thyroid hormones)
Japan	2003081870	PHARMACEUTICAL FORMULATION FOR THYROID HORMONE

Supplementary Protection Certificates for TIROSINT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy		PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808