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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

Last Updated: September 29, 2023

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, 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 eighty-one patent family members in twenty-four 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.

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

Xeris PharmaceuticalsPhase 2
CromsourcePhase 4
University of California, Los AngelesPhase 4

See all levothyroxine sodium clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MCG/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 Classl-Thyroxine
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Institut Biochimique TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-008 Dec 15, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-003 Jun 24, 2011 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Institut Biochimique TIROSINT levothyroxine sodium CAPSULE;ORAL 021924-012 Apr 25, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-006 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-010 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-002 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Institut Biochimique TIROSINT levothyroxine sodium CAPSULE;ORAL 021924-015 Jun 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

International Patents for levothyroxine sodium

Country Patent Number Title Estimated Expiration
Germany 60207951 ⤷  Try a Trial
Brazil 0207297 ⤷  Try a Trial
Portugal 3528847 ⤷  Try a Trial
Hungary E028423 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03070217 ⤷  Try a Trial
Austria 447939 ⤷  Try a Trial
>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 ⤷  Try a 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts

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.