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LEVOTHYROXINE SODIUM

NDA

LEVOTHYROXINE SODIUM | N202231 | FRESENIUS KABI USA LLC

3 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)TodayIPRPTAB Challenge

2027

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2029

2030

2031

2032

2033

Today

9006289

Oct. 3, 2032IPR

9168238

Aug. 29, 2032IPR

9168239

Aug. 29, 2032IPR

PTAB Proceedings

3 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2017-00645	9006289	IPR	Mylan Institutional Inc.	Terminated-Settled	2017-01-19	—
IPR2017-00643	9168238	IPR	Mylan Institutional Inc.	Terminated-Settled	2017-01-19	—
IPR2017-00644	9168239	IPR	Mylan Institutional Inc.	Terminated-Settled	2017-01-19	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Fresenius Kabi USA, LLC v. Custopharm, Inc. 1:2020cv03254 2 patentslevothyroxine sodium	COD	2020-10-30	Terminated 2021-02-19	—
FRESENIUS KABI USA, LLC. v. PAR STERILE PRODUCTS, LLC et al 2:2015cv03852 1 patentANDA 205366levothyroxine sodium	D.N.J.	2015-06-09	Terminated 2016-03-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

SANDOZ GMBHLEVOTHYROXINE SODIUM

DMF 47891983

PEPTIDO GMBHLEVOTHYROXINE SODIUM

DMF 147152000

EXCELLA GMBH AND CO KGLEVOTHYROXINE SODIUM

DMF 244022011

AZICO BIOPHORE INDIA PVT LTDLEVOTHYROXINE SODIUM

DMF 290982015

GLAND PHARMA LTDLEVOTHYROXINE SODIUM USP

DMF 295502015

LUPIN LTDLEVOTHYROXINE SODIUM USP

DMF 303762016

MACLEODS PHARMACEUTICALS LTDLEVOTHYROXINE SODIUM USP

DMF 312032017

AURORE LIFE SCIENCES PRIVATE LTDLEVOTHYROXINE SODIUM USP

DMF 340442019

VALARY LAB PRIVATE LTDLEVOTHYROXINE SODIUM

DMF 381292023

SUN PHARMACEUTICAL INDUSTRIES LTDLEVOTHYROXINE SODIUM USP

DMF 427812025

RHODIA INDUSTRIE CHIMIQUE MULHOUSE DORNACHInactiveLEVOTHYROXINE SODIUM USP

DMF 142561999

APOTEX PHARMACHEM INDIA PVT LTDInactiveLEVOTHYROXINE SODIUM USP

DMF 258182012

APOTEX PHARMACHEM INDIA PVT LTDInactiveLEVOTHYROXINE SODIUM USP

DMF 301132016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 26, 2012	SUPPL -3	View Letter (PDF)
Jul 5, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MCG/VIAL

RLDAP

3 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 24, 2011

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9006289	Oct 3, 2032	—	—	Yes	—	—
9168238	Aug 29, 2032	—	—	Yes	—	—
9168239	Aug 29, 2032	—	—	Yes	—	—

#002 — 200MCG/VIAL

RLDAP

3 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 24, 2011

#003 — 500MCG/VIAL

RLDAP

3 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 24, 2011