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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
QuintilesIMS
Express Scripts
AstraZeneca
Federal Trade Commission
Novartis
Harvard Business School
Merck
Boehringer Ingelheim

Generated: February 24, 2018

DrugPatentWatch Database Preview

LEVOTHYROXINE SODIUM Drug Profile

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When do Levothyroxine Sodium patents expire, and what generic alternatives are available?

Levothyroxine Sodium is a drug marketed by Fresenius Kabi Usa, Par Sterile Products, Piramal Critical, Merck Kgaa, and Mylan. and is included in five NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the levothyroxine sodium profile page.
Drug patent expirations by year for LEVOTHYROXINE SODIUM
Pharmacology for LEVOTHYROXINE SODIUM
Ingredient-typeThyroxine
Drug Classl-Thyroxine

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 076187-008 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-005 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-009 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-006 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-001 Jun 24, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Kgaa LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076752-006 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-001 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-003 Jun 24, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-002 Jun 24, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Piramal Critical LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 206163-002 Jun 29, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 4/14/2015
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 5/1/2015

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cerilliant
Baxter
QuintilesIMS
Colorcon
US Army
Covington
Federal Trade Commission
Medtronic

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