Viewing data from:

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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-5491 · 7 docket documents 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	Granted	Lachman Consulting Services, Inc.

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

Clinical Trials

26 trials from ClinicalTrials.gov, 1 active, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of ARDS With Instilled T3 NCT04115514	Phase 2	Active	University of Minnesota	68	2020-03-30 → 2026-10-31
A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin NCT01182285	Phase 2	Completed	National Cancer Institute (NCI)	13	2010-09-24 → 2016-04-28
Effects of Liothyronine on Energy Expenditure and Cardiovascular Function NCT03098433	Phase 1/2	Completed	Virginia Commonwealth University	22	2017-10-20 → 2019-06-24
Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients NCT03053115	Phase 2/3	Completed	Azienda USL Modena	160	2017-03-14 → 2022-06-30
A Study of T3 Therapy in Patients With Hypothyroidism NCT01800617	Phase 2	Completed	Ipe, LLC	18	2013-03
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery NCT01153360	N/A	Completed	Yonsei University	100	2010-06 → 2011-09
Identification of Non-responders to Levothyroxine Therapy NCT03627611	Phase 2	Completed	Oslo University Hospital	69	2018-08-14 → 2020-06-22
Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study NCT02760056	Phase 1	Completed	Oregon Health and Science University	15	2016-06-06 → 2017-01-10
Thyroid and Glucose and Energy Metabolism NCT00106119	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	18	2005-03 → 2013-11
Study of Triostat in Infants During Heart Surgery NCT00027417	Phase 3	Completed	Michael Portman	195	2001-04 → 2007-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs (2 brand, 3 generic)

Highest NADAC/Unit

$0.5295

per ea

Lowest NADAC/Unit

$0.2283

per ea

Brand NDCs

Generic NDCs

Avg Brand: $0.4579

Avg Generic: $0.3030

34% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60793011601CYTOMEL 25 MCG TABLET	$0.5295	EA	Brand	$0.3191	2026-06-17
60793011501CYTOMEL 5 MCG TABLET	$0.3862	EA	Brand	$0.2283	2026-06-17
59762120801LIOTHYRONINE SOD 50 MCG TAB	$0.3615	EA	Generic	—	2026-06-17
59762120701LIOTHYRONINE SOD 25 MCG TAB	$0.3191	EA	Generic	—	2026-06-17
59762120601LIOTHYRONINE SOD 5 MCG TAB	$0.2283	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$13.12

Highest Price

$90.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60793-0116-01CYTOMEL 25MCG TAB	$53.95	FSS	Pfizer Inc.	06/30/2029
60793-0116-01CYTOMEL 25MCG TAB	$26.61	Big4	Pfizer Inc.	06/30/2029
60793-0117-01CYTOMEL 50MCG TAB	$90.66	FSS	Pfizer Inc.	06/30/2029
60793-0117-01CYTOMEL 50MCG TAB	$29.48	Big4	Pfizer Inc.	06/30/2029
59762-1207-01LIOTHYRONINE NA 25MCG TAB	$52.27	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-1207-01LIOTHYRONINE NA 25MCG TAB	$13.12	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cytomel (2024)

Total Spending

$414K

Total Claims

8,950

Beneficiaries

2,398

Avg Cost/Unit

$0.40

Spending Trend

$2.8M(2019)→$2.7M(2020)→$2.5M(2021)→$2.0M(2022)→$2.0M(2023)→$414K(2024)

YoY Change:-80.3%

5yr CAGR:-33.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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 PRIVATE LIMITEDLIOTHYRONINE 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