LEVOTHYROXINE SODIUM Drug Patent Profile

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

Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva. and is included in eighteen NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has five patent family members in three countries.

The generic ingredient in LEVOTHYROXINE SODIUM 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 Levothyroxine Sodium

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

Summary for LEVOTHYROXINE SODIUM

International Patents:	5
US Patents:	7
Applicants:	16
NDAs:	18
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	190
Clinical Trials:	24
Patent Applications:	4,212
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for LEVOTHYROXINE SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOTHYROXINE SODIUM
What excipients (inactive ingredients) are in LEVOTHYROXINE SODIUM?	LEVOTHYROXINE SODIUM excipients list
DailyMed Link:	LEVOTHYROXINE SODIUM at DailyMed

See drug sales revenues for LEVOTHYROXINE SODIUM

Recent Clinical Trials for LEVOTHYROXINE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Xeris Pharmaceuticals	Phase 2
Cromsource	Phase 4
University of California, Los Angeles	Phase 4

See all LEVOTHYROXINE SODIUM clinical trials

Pharmacology for LEVOTHYROXINE SODIUM

Drug Class

l-Thyroxine

Anatomical Therapeutic Chemical (ATC) Classes for LEVOTHYROXINE SODIUM

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

Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THYQUIDITY	Oral Solution	levothyroxine sodium	100 mcg/5 mL	214047	1	2022-12-28
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
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
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
LEVOTHYROXINE SODIUM	for Injection	levothyroxine sodium	200 mcg/vial	202231	1	2015-05-01
LEVOTHYROXINE SODIUM	for Injection	levothyroxine sodium	100 mcg/vial and 500 mcg/vial	202231	2	2015-04-14

US Patents and Regulatory Information for LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM is protected by seven US patents.

Patents protecting LEVOTHYROXINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	215259-010	Jan 18, 2023	AB4	RX	No	No
Merck Kgaa	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076752-003	Jun 16, 2005		DISCN	No	No
Accord Hlthcare	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	212399-003	Oct 19, 2020	AB1,AB2,AB3,AB4	RX	No	No
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632-002	Apr 11, 2019		RX	Yes	Yes			Y
Lupin	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	209713-012	Jan 18, 2019	AB1,AB2,AB3	RX	No	No
Mylan	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076187-005	Jun 5, 2002	AB1,AB2,AB3,AB4	RX	No	No
Accord Hlthcare	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	212399-011	Oct 19, 2020	AB1,AB2,AB3,AB4	RX	No	No

International Patents for LEVOTHYROXINE SODIUM

See the table below for patents covering LEVOTHYROXINE SODIUM around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018102145
European Patent Office	2750664	FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS)
Canada	3045794	FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS)
World Intellectual Property Organization (WIPO)	2013033194
World Intellectual Property Organization (WIPO)	2017013591