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Levothyroxine sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levothyroxine sodium?

Levothyroxine sodium is the generic ingredient in ten branded drugs marketed by King Pharms R And D, Abbvie, Stevens J, Lloyd, Institut Biochimique, Fresenius Kabi Usa, Lehigh Valley, Alara Pharm, Merck Kgaa, Fera Pharms Llc, Par Sterile Products, and Mylan, and is included in fifteen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-two patent family members in sixteen countries.

There are nine drug master file entries for levothyroxine sodium. Forty-four suppliers are listed for this compound.

Summary for Generic Name: levothyroxine sodium

Drug Master File Entries: see list9
Suppliers / Packagers: see list44
Bulk Api Vendors: see list114
Clinical Trials: see list941
Patent Applications: see list12,654
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:levothyroxine sodium at DailyMed

Pharmacology for Ingredient: levothyroxine sodium

Drug Classl-Thyroxine
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
levothyroxine sodium
TABLET;ORAL076187-005Jun 5, 2002RXNoNo► Subscribe► Subscribe
Fresenius Kabi Usa
levothyroxine sodium
POWDER;INTRAVENOUS202231-002Jun 24, 2011RXYesYes9,168,239► SubscribeY ► Subscribe
Institut Biochimique
levothyroxine sodium
SOLUTION;ORAL206977-012Dec 15, 2016RXYesYes► Subscribe► Subscribe
Merck Kgaa
levothyroxine sodium
TABLET;ORAL021292-005May 31, 2002DISCNNoNo► Subscribe► Subscribe
levothyroxine sodium
TABLET;ORAL021116-010Oct 24, 2002DISCNYesNo► Subscribe► Subscribe
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International Patent Family for Ingredient: levothyroxine sodium

Country Document Number Estimated Expiration
Israel152024► Subscribe
Brazil0207299► Subscribe
Spain2334777► Subscribe
Australia2002341555► Subscribe
Norway20033637► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.