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Levothyroxine sodium - Generic Drug Details

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Levothyroxine sodium is the generic ingredient in ten branded drugs marketed by King Pharms R And D, Abbvie, Stevens J, Lloyd, Inst Biochimique, Institut Biochimique, Fresenius Kabi Usa, Lehigh Valley, Alara Pharm, Merck Kgaa, Fera Pharms Llc, Par Sterile Products, Ibsa Inst Bio, 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-three suppliers are listed for this compound.

Summary for Generic Name: levothyroxine sodium

Drug Master File Entries: see list9
Suppliers / Packagers: see list43
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;ORAL021116-001Oct 24, 2002DISCNYesNo► subscribe► subscribe
King Pharms R And D
levothyroxine sodium
TABLET;ORAL021301-005May 25, 2001RXYesNo7,067,148► subscribeY ► subscribe
Lehigh Valley
levothyroxine sodium
TABLET;ORAL021137-007Jun 6, 2003DISCNNoNo► subscribe► subscribe
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International Patent Family for Ingredient: levothyroxine sodium

Country Document Number Estimated Expiration
Australia2002341555► subscribe
World Intellectual Property Organization (WIPO)0174448► subscribe
Canada2438907► 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.