➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Merck
Dow
McKinsey
Harvard Business School

Last Updated: January 15, 2021

DrugPatentWatch Database Preview

LEVOTHYROXINE SODIUM Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Levothyroxine Sodium, and when can generic versions of Levothyroxine Sodium launch?

Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, and Mylan. and is included in twelve NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has four patent family members in three countries.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Levothyroxine Sodium

A generic version of LEVOTHYROXINE SODIUM was approved as levothyroxine sodium by MYLAN on June 5th, 2002.

  Start Trial

Drug patent expirations by year for LEVOTHYROXINE SODIUM
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
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

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 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
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-001 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No   Start Trial   Start Trial   Start Trial
Amneal LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-005 Feb 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 212399-008 Oct 19, 2020 AB2 RX No No   Start Trial   Start Trial   Start Trial
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-001 Jan 18, 2019 AB1,AB2,AB3 RX No No   Start Trial   Start Trial   Start Trial
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-012 Jan 18, 2019 AB1,AB2,AB3 RX No No   Start Trial   Start Trial   Start Trial
Amneal LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-009 Feb 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-002 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Colorcon
Harvard Business School
Boehringer Ingelheim
Mallinckrodt

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.