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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
US Department of Justice
Moodys
Cantor Fitzgerald
Boehringer Ingelheim
Baxter
Federal Trade Commission
Fuji
Medtronic

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for Patent: 9,168,239

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Which drugs does patent 9,168,239 protect, and when does it expire?


Patent 9,168,239 protects LEVOTHYROXINE SODIUM and is included in one NDA. There have been two Paragraph IV challenges on Levothyroxine Sodium.

This patent has two patent family members in two countries.

Summary for Patent: 9,168,239

Title:Levothyroxine formulations
Abstract: A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.
Inventor(s): Jiang; John Zhiqiang (Skokie, IL), Usayapant; Arunya (Mundelein, IL), Monen; George (Woodridge, IL)
Assignee: Fresenius Kabi USA, LLC (Lake Zurich, IL)
Application Number:14/658,058
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Fresenius Kabi Usa
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS202231-001Jun 24, 2011APRXYesYes► Subscribe► SubscribeY
Fresenius Kabi Usa
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS202231-002Jun 24, 2011APRXYesYes► Subscribe► SubscribeY
Fresenius Kabi Usa
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS202231-003Jun 24, 2011APRXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 9,168,239

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,006,289Levothyroxine formulations► Subscribe
9,168,238Levothyroxine formulations► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 9,168,239

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office2750664► 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 leading biopharmaceutical companies globally:

Novartis
Cipla
Harvard Business School
Queensland Health
Cerilliant
Boehringer Ingelheim
Teva
Mallinckrodt
Argus Health
Chinese Patent Office

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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