LEVOTHYROXINE SODIUM - Generic Drug Details

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

Levothyroxine sodium is the generic ingredient in eleven branded drugs marketed by Teva Pharms Usa Inc, Institut Biochimique, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, EMP, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, Mylan, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-three NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for LEVOTHYROXINE SODIUM

International Patents:	77
US Patents:	13
Tradenames:	11
Applicants:	20
NDAs:	23
Drug Master File Entries:	10
Suppliers / Packagers:	37
Bulk Api Vendors:	165
Clinical Trials:	18
Patent Applications:	6,565
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

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
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
First People's Hospital of Hangzhou	Phase 4
Zhejiang Provincial Hospital of TCM	Phase 4

See all LEVOTHYROXINE SODIUM clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	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	NDA	Submissiondate
TIROSINT	CAPSULE;ORAL	levothyroxine sodium	021924	2020-12-18
TIROSINT	CAPSULE;ORAL	levothyroxine sodium	021924	2019-08-01
TIROSINT	CAPSULE;ORAL	levothyroxine sodium	021924	2017-12-29
LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	levothyroxine sodium	202231	2015-05-01
LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	levothyroxine sodium	202231	2015-04-14
LEVOXYL	TABLET;ORAL	levothyroxine sodium	021301

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
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-009	May 25, 2001	AB1,AB3	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Mylan	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076187-008	Jun 5, 2002	AB1,AB2,AB3,AB4	RX	No	No	Start Trial	Start Trial				Start Trial
Institut Biochimique	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-002	Oct 13, 2006		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231-003	Jun 24, 2011	AP	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Merck Kgaa	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	076752-004	Jun 16, 2005		DISCN	No	No	Start Trial	Start Trial				Start Trial
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210-002	Aug 21, 2000	AB1,AB2,AB3	RX	Yes	No	Start Trial	Start Trial				Start Trial
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-007	Oct 24, 2002	AB2,AB4	RX	Yes	No	Start Trial	Start Trial				Start Trial
>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	021342-003	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-004	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-005	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-001	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-010	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-006	Mar 1, 2002	Start Trial	Start Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-009	Mar 1, 2002	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LEVOTHYROXINE SODIUM

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013033194	Start Trial
South Korea	20040100835	Start Trial
Slovenia	1433478	Start Trial
Portugal	2683361	Start Trial
Mexico	PA03007337	Start Trial
World Intellectual Property Organization (WIPO)	02064093	Start Trial
Japan	2004210780	Start Trial
>Country	>Patent Number	>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	Start Trial	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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