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Details for Patent: 9,168,238

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Which drugs does patent 9,168,238 protect, and when does it expire?

Patent 9,168,238 protects LEVOTHYROXINE SODIUM and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 9,168,238

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:	14/641,426
Patent Claim Types: see list of patent claims	Composition; Formulation; Use;

Drugs Protected by US Patent 9,168,238

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231-001	Jun 24, 2011	AP	RX	Yes	Yes			Y
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231-002	Jun 24, 2011	AP	RX	Yes	Yes			Y
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231-003	Jun 24, 2011	AP	RX	Yes	Yes			Y

Non-Orange Book US Patents Family Members for Patent 9,168,238

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
9,006,289	Levothyroxine formulations
9,168,239	Levothyroxine formulations

International Patents Family Members for US Patent 9,168,238

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2750664
World Intellectual Property Organization (WIPO)	2013033194