Viewing data from:

LEVOXYL

NDA

LEVOTHYROXINE SODIUM | N021301 | KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC

12 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

76 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin NCT06373523	Early Phase 1	Active	Post Graduate Institute of Medical Education and Research, Chandigarh	50	2024-01-15 → 2026-12-31
Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism NCT07787585	Phase 4	Not Yet Recruiting	Spyridoula Maraka	138	2027-10 → 2031-09
T4/T3 Therapy in Hypothyroidism NCT07424183	Phase 2	Not Yet Recruiting	University of Pennsylvania	60	2026-11 → 2027-11
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients NCT03977207	N/A	Recruiting	University of California, Irvine	336	2020-07-20 → 2025-11-30
Levothyroxine Supplementation for Heart Transplant Recipients NCT06428097	Phase 1	Recruiting	University of California, San Francisco	97	2024-03-29 → 2027-03-01
Thyroid Hormone Replacement for Subclinical Hypothyroidism NCT01660126	Phase 4	Completed	NHS Greater Glasgow and Clyde	737	2014-05 → 2016-11-18
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants NCT04124705	Phase 2	Completed	Allergan	284	2019-10-11 → 2021-06-22
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors NCT03094416	Phase 4	Completed	IBSA Institut Biochimique SA	66	2018-07-30 → 2020-06-15
Bioequivalence of Two Levothyroxine Tablet Formulations in Healthy Indian Volunteers NCT01536678	Phase 4	Completed	GlaxoSmithKline	26	2012-01 → 2012-04
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg NCT00648700	Phase 1	Completed	Mylan Pharmaceuticals Inc	32	2005-08 → 2005-09

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 22 NDCs

Highest NADAC/Unit

$1.39

per ea

Lowest NADAC/Unit

$0.7526

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60793085910LEVOXYL 175 MCG TABLET	$1.39	EA	Brand	$0.0765	2026-08-19
60793085901LEVOXYL 175 MCG TABLET	$1.39	EA	Brand	$0.0765	2026-08-19
60793086001LEVOXYL 200 MCG TABLET	$1.35	EA	Brand	$0.0802	2026-08-19
60793086010LEVOXYL 200 MCG TABLET	$1.35	EA	Brand	$0.0802	2026-08-19
60793085810LEVOXYL 150 MCG TABLET	$1.17	EA	Brand	$0.0597	2026-08-19
60793085801LEVOXYL 150 MCG TABLET	$1.17	EA	Brand	$0.0597	2026-08-19

Showing 6 of 22 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 22 NDCs (22 FSS)

Lowest Price

$59.69

Highest Price

$1100.78

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60793-0850-01LEVOXYL 25MCG TAB	$59.69	FSS	Pfizer Inc.	06/30/2029
60793-0850-10LEVOXYL 25MCG TAB	$596.89	FSS	Pfizer Inc.	06/30/2029
60793-0851-01LEVOXYL 50MCG TAB	$67.76	FSS	Pfizer Inc.	06/30/2029
60793-0851-10LEVOXYL 50MCG TAB	$677.57	FSS	Pfizer Inc.	06/30/2029
60793-0852-01LEVOXYL 75MCG TAB	$74.87	FSS	Pfizer Inc.	06/30/2029
60793-0852-10LEVOXYL 75MCG TAB	$748.78	FSS	Pfizer Inc.	06/30/2029

Showing 6 of 22 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Levoxyl (2024)

Total Spending

$6.1M

Total Claims

157,517

Beneficiaries

39,693

Avg Cost/Unit

$0.52

Spending Trend

$5.7M(2019)→$6.2M(2020)→$6.3M(2021)→$5.4M(2022)→$4.8M(2023)→$6.1M(2024)

YoY Change:+20.8%

5yr CAGR:-2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

5 letters from Drugs@FDA

Date	Submission	Document
Jul 10, 2008	SUPPL -26	View Letter (PDF)
Mar 10, 2005	SUPPL -14	View Letter (PDF)
Aug 6, 2003	SUPPL -6	View Letter (PDF)
Jul 17, 2002	SUPPL -2	View Letter (PDF)
May 25, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (12)

Sort:

#001 — 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

RLDAB1,AB3

0 patents0 exclusivities▴