LEVOTHYROXINE SODIUM - Generic Drug Details

What are the generic 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, Institut Biochimique, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Custopharm Inc, Mylan, Vistapharm, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-six NDAs. There are seventeen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for LEVOTHYROXINE SODIUM

International Patents:	74
US Patents:	17
Tradenames:	12
Applicants:	22
NDAs:	26
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	22
Patent Applications:	6,539
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
Cromsource	Phase 4
University of California, Los Angeles	Phase 4
First People's Hospital of Hangzhou	Phase 4

See all LEVOTHYROXINE SODIUM clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM

Applicant	Application No.	Strength	Dosage Form
		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

Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076187-011	Jun 5, 2002	AB1,AB2,AB3,AB4	RX	No	Yes
Mylan	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076187-003	Jun 5, 2002	AB1,AB2,AB3,AB4	RX	No	No
Institut Biochimique	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007		RX	Yes	No			Y

Expired US Patents for LEVOTHYROXINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-004	Mar 1, 2002
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-007	May 25, 2001
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-006	May 25, 2001

International Patents for LEVOTHYROXINE SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3528847	SOLUTIONS CONDITIONNÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)
Poland	3528847
Cyprus	1117151

Supplementary Protection Certificates for LEVOTHYROXINE SODIUM

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