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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Johnson and Johnson
Teva
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US Department of Justice
Moodys
Boehringer Ingelheim
Express Scripts

Generated: December 14, 2017

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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 Institut Biochimique, Fera Pharms Llc, Fresenius Kabi Usa, Par Sterile Products, Alara Pharm, Genus Lifesciences, Merck Kgaa, Mylan, King Pharms, Abbvie, Lloyd, and Stevens J, 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-five patent family members in sixteen countries.

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

Pharmacology for levothyroxine sodium

Ingredient-typeThyroxine
Drug Classl-Thyroxine

Tentative approvals for LEVOTHYROXINE SODIUM

Applicant Application No. Strength Dosage Form
u► Subscribe200MCG/VIALPOWDER;INTRAVENOUS
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Institut BiochimiqueTIROSINTlevothyroxine sodiumCAPSULE;ORAL021924-008Oct 2, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck KgaaNOVOTHYROXlevothyroxine sodiumTABLET;ORAL021292-007May 31, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Stevens JUNITHROIDlevothyroxine sodiumTABLET;ORAL021210-005Aug 21, 2000AB1,AB2,AB3RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanLEVOTHYROXINE SODIUMlevothyroxine sodiumTABLET;ORAL076187-006Jun 5, 2002AB1,AB2,AB3,AB4RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanLEVOTHYROXINE SODIUMlevothyroxine sodiumTABLET;ORAL076187-007Jun 5, 2002AB1,AB2,AB3,AB4RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Genus LifesciencesLEVOLETlevothyroxine sodiumTABLET;ORAL021137-010Jun 6, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Institut BiochimiqueTIROSINTlevothyroxine sodiumCAPSULE;ORAL021924-009Oct 2, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
LloydTHYRO-TABSlevothyroxine sodiumTABLET;ORAL021116-012Dec 7, 2004DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck KgaaNOVOTHYROXlevothyroxine sodiumTABLET;ORAL021292-011May 31, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Institut BiochimiqueTIROSINTlevothyroxine sodiumCAPSULE;ORAL021924-007Oct 13, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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International Patent Family for Ingredient: levothyroxine sodium

Country Document Number Estimated Expiration
Australia2002258397► Subscribe
Brazil0207297► Subscribe
Brazil0207299► Subscribe
European Patent Office2750664► Subscribe
World Intellectual Property Organization (WIPO)02064093► Subscribe
Canada2438907► Subscribe
Denmark1291021► Subscribe
Slovenia1433478► Subscribe
World Intellectual Property Organization (WIPO)03070217► Subscribe
Brazil0109736► 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 leading biopharmaceutical companies globally:

Fuji
Chubb
Cantor Fitzgerald
Fish and Richardson
Medtronic
Queensland Health
AstraZeneca
Teva
US Department of Justice
Citi

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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