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LEVOTHYROXINE SODIUM

NDA

LEVOTHYROXINE SODIUM | N210632 | FRESENIUS KABI USA LLC

3 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

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2035

2036

2037

Today

9782376

Dec. 1, 2036

10398669

Dec. 1, 2036

11135190

Dec. 1, 2036

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

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. ENDO OPERATIONS LIMITED et al 2:2025cv02861 3 patentslevothyroxine sodium	D.N.J.	2025-04-18	Terminated 2025-07-15	—
Fresenius Kabi USA, LLC v. Custopharm, Inc. 1:2020cv03254 2 patentslevothyroxine sodium	COD	2020-10-30	Terminated 2021-02-19	—

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

1 letter from Drugs@FDA

Date	Submission	Document
Apr 12, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MCG/5ML (20MCG/ML)

RLD

3 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 11, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9782376	Dec 1, 2036	—	—	Yes	—	—
10398669	Dec 1, 2036	—	—	Yes	—	—
11135190	Dec 1, 2036	—	—	Yes	—	—

#002 — 200MCG/5ML (40MCG/ML)

RLD

3 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 11, 2019

#003 — 500MCG/5ML (100MCG/ML)

RLD

3 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 11, 2019