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CYTOMEL

NDA

LIOTHYRONINE SODIUM | N010379 | KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC

3 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-5491 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Liothyronine Sodium Tablets in 10 mcg, 15 mcg, and 20 mcg strengths suitable for submission as an Abbreviated New Drug Application,	Suitability	2025-10-20	Open	Lachman Consulting Services

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Cytomel (2023)

Total Spending

$2.0M

Total Claims

8,907

Beneficiaries

2,302

Avg Cost/Unit

$2.03

Spending Trend

$2.8M(2019)→$2.7M(2020)→$2.5M(2021)→$2.0M(2022)→$2.0M(2023)

YoY Change:-7.4%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs1 inactive

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

PEPTIDO GMBHLIOTHYRONINE SODIUM

DMF 194672006

AZICO BIOPHORE INDIA PVT LTDLIOTHYRONINE SODIUM

DMF 309422016

VALARY LAB LTDLIOTHYRONINE SODIUM

DMF 389032023

MACLEODS PHARMACEUTICALS LTDLIOTHYRONINE SODIUM USP

DMF 424012025

SANDOZ GMBHInactiveLIOTHYRONINE SODIUM

DMF 71101987

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 15, 2020	SUPPL -57	View Letter (PDF)
Dec 31, 2018	SUPPL -54	View Letter (PDF)
May 17, 2002	SUPPL -47	View Letter (PDF)
Sep 13, 2001	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.005MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 0.025MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 0.05MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982