TIROSINT Drug Patent Profile

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Which patents cover Tirosint, 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. 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

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

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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
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

Drug patent expirations by year 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

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

Pharmaceutical formulae for thyroid hormones and procedures for obtaining them
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Patent Expiration: ⤷ Sign Up

Pharmaceutical formulations for thyroid hormones
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Patent Expiration: ⤷ Sign Up

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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	206977-009	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-002	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	206977-006	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-015	Jan 13, 2021		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
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-001	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TIROSINT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-004	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-002	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-005	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-007	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-009	Oct 2, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TIROSINT

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

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Country	Patent Number	Title	Estimated Expiration
Austria	447939		⤷ Sign Up
Spain	2334777		⤷ Sign Up
Germany	60207951		⤷ Sign Up
Denmark	1433478		⤷ Sign Up
Austria	312621		⤷ Sign Up
Italy	MI20011401		⤷ Sign Up
Japan	5105685		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TIROSINT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy	⤷ Sign Up	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