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, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Zydus Pharms, Hikma, Mylan, Azurity, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Ascent Pharms Inc, Lupin, Macleods Pharms Ltd, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-nine 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. Forty-eight 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:	25
NDAs:	29
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	190
Clinical Trials:	25
Patent Applications:	6,599
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
National Institute on Aging (NIA)	Phase 4
University of Pennsylvania	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
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-011	Dec 15, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Piramal Critical	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	206163-002	Jun 29, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-001	May 25, 2001	AB1,AB3	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	LEVOTHYROXINE SODIUM	levothyroxine sodium	CAPSULE;ORAL	213256-001	Jan 6, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-010	Mar 1, 2002	AB1,AB2,AB3	RX	No	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	021342-008	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-001	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-006	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	021924-002	Oct 13, 2006	⤷ 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
Germany	60329968		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018102145		⤷ Sign Up
European Patent Office	2750664	FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS)	⤷ Sign Up
Slovenia	1433478		⤷ Sign Up
Slovenia	3261676		⤷ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.