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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Federal Trade Commission

Generated: August 23, 2017

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 levothyroxine sodium freedom to operate?

Levothyroxine sodium
is the generic ingredient in ten branded drugs marketed by King Pharms, 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.

Levothyroxine sodium has fifty-two patent family members in sixteen countries.

There are ten drug master file entries for levothyroxine sodium. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: levothyroxine sodium

Drug Master File Entries: see list10
Suppliers / Packagers: see list42
Bulk Api Vendors: see list114
Clinical Trials: see list2,419
Patent Applications: see list7,574
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

Tentative approvals for LEVOTHYROXINE SODIUM

Applicant Application No. Strength Dosage Form
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
levothyroxine sodium
TABLET;ORAL021116-010Oct 24, 2002DISCNYesNo► Subscribe► Subscribe► Subscribe
Institut Biochimique
levothyroxine sodium
CAPSULE;ORAL021924-002Oct 13, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Merck Kgaa
levothyroxine sodium
TABLET;ORAL076752-004Jun 16, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Stevens J
levothyroxine sodium
TABLET;ORAL021210-002Aug 21, 2000AB1,AB2,AB3RXYesNo► Subscribe► Subscribe► Subscribe
levothyroxine sodium
TABLET;ORAL021402-011Jul 24, 2002AB1,AB2RXYesYes► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: levothyroxine sodium

Country Document Number Estimated Expiration
Austria312621► Subscribe
European Patent Office1433478► Subscribe
Norway20033637► Subscribe
Canada2440190► Subscribe
World Intellectual Property Organization (WIPO)2013033194► 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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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
US Army
Johnson and Johnson

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.

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