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Last Updated: July 2, 2022

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, 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 eighteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

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

SponsorPhase
CromsourcePhase 4
University of California, Los AngelesPhase 4
First People's Hospital of HangzhouPhase 4

See all levothyroxine sodium clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing200MCG/VIALPOWDER;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 076187-004 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-007 Jun 6, 2003 AB1,AB3,AB4 RX No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-006 Jun 6, 2003 AB1,AB3,AB4 RX No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-008 Jan 18, 2019 AB1,AB2,AB3 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms LEVOXYL levothyroxine sodium TABLET;ORAL 021301-009 May 25, 2001 See Plans and Pricing See Plans and Pricing
King Pharms LEVOXYL levothyroxine sodium TABLET;ORAL 021301-003 May 25, 2001 See Plans and Pricing See Plans and Pricing
King Pharms LEVOXYL levothyroxine sodium TABLET;ORAL 021301-009 May 25, 2001 See Plans and Pricing See Plans and Pricing
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-004 Mar 1, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for levothyroxine sodium

Country Patent Number Title Estimated Expiration
European Patent Office 3261676 FORMULATIONS LIQUIDES DE LÉVOTHYROXINE (LIQUID LEVOTHYROXINE FORMULATIONS) See Plans and Pricing
Japan 5105685 See Plans and Pricing
Cyprus 1117151 See Plans and Pricing
Russian Federation 2765547 ВЫСОКОСТАБИЛЬНЫЕ УПАКОВАННЫЕ РАСТВОРЫ ТИРЕОИДНОГО ГОРМОНА Т4 (HIGHLY STABLE PACKAGED SOLUTIONS OF THE THYROID HORMONE T4) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levothyroxine sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1291021 132012902104794 Italy See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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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.