Levothyroxine sodium - Generic Drug Details

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What are the generic drug sources for levothyroxine sodium and what is the scope of patent protection?

Levothyroxine sodium is the generic ingredient in twelve branded drugs marketed by Teva Pharms Usa Inc, Ibsa, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, Zydus Pharms, Hikma, Mylan, Azurity, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in thirty NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levothyroxine sodium has sixty-four patent family members in twenty countries.

There are ten drug master file entries for levothyroxine sodium. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for levothyroxine sodium

International Patents:	64
US Patents:	16
Tradenames:	12
Applicants:	26
NDAs:	30
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	190
Clinical Trials:	25
Patent Applications:	6,580
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

Drug Sales Revenue Trends for levothyroxine sodium

See drug sales revenues for levothyroxine sodium

Recent Clinical Trials for levothyroxine sodium

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

Sponsor	Phase
University of Pennsylvania	Phase 4
National Institute on Aging (NIA)	Phase 4
Xeris Pharmaceuticals	Phase 2

See all levothyroxine sodium clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MCG/VIAL	POWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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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
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210-003	Aug 21, 2000	AB1,AB2,AB3	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Provell	EUTHYROX	levothyroxine sodium	TABLET;ORAL	021292-001	May 31, 2002	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genus Lifesciences	LEVOLET	levothyroxine sodium	TABLET;ORAL	021137-003	Jun 6, 2003	AB1,AB2,AB3,AB4	RX	No	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merck Kgaa	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076752-002	Jun 16, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-002	May 25, 2001	AB1,AB3	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 levothyroxine sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-005	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-010	May 25, 2001	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-003	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-010	May 25, 2001	⤷ Sign Up	⤷ Sign Up
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-006	May 25, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for levothyroxine sodium

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Country	Patent Number	Title	Estimated Expiration
Spain	2824787		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013033194		⤷ Sign Up
European Patent Office	4321214	SCHÉMA D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION)	⤷ Sign Up
European Patent Office	1433478	Formes de dosage contenant des hormones thyroidiennes et procédé de préparation de ces formes (Pharmaceutical formulae for thyroid hormones and procedures for obtaining them)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020178074		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for levothyroxine sodium

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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

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