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Last Updated: April 10, 2021

DrugPatentWatch Database Preview

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 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.

Drug Sales Revenue Trends for levothyroxine sodium

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Recent Clinical Trials for levothyroxine sodium

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SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
First People's Hospital of HangzhouPhase 4
Zhejiang Provincial Hospital of TCMPhase 4

See all levothyroxine sodium clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-007 Oct 24, 2002 AB2,AB4 RX Yes No   Start Trial   Start Trial   Start Trial
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-010 Mar 1, 2002 AB1,AB2,AB3 RX No No   Start Trial   Start Trial   Start Trial
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-006 Mar 1, 2002 AB1,AB2,AB3 RX No No   Start Trial   Start Trial   Start Trial
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-011 Jan 18, 2019 AB1,AB2,AB3 RX No 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-009 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 021342-005 Mar 1, 2002   Start Trial   Start Trial
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-011 Mar 1, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for levothyroxine sodium

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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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.