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UNITHROID

NDA

LEVOTHYROXINE SODIUM | N021210 | JEROME STEVENS PHARMACEUTICALS INC

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

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

Citizen Petitions

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from VRT Pharma Consulting, LLC FDA-2023-P-5654 · 14 docket documents VRT Pharma Consulting LLC, on behalf of Neuheit Pharma Technologies Private Ltd, filed an amendment to a suitability petition seeking FDA permission to submit an ANDA for levothyroxine sodium sublingual tablets in 12 strengths ranging from 25 mcg to 300 mcg as a change in route of administration fro	Suitability	2024-02-02	Denied	—
Attachment 2 - Labeling for SYNTHROID (Levothyroxine sodium) tablets RE Suita... FDA-2023-P-1988 · 10 docket documents Neuheit Pharma Technologies Pvt Ltd filed a suitability petition regarding labeling for SYNTHROID (levothyroxine sodium) tablets, seeking FDA review and approval of proposed labeling changes for this levothyroxine sodium product.	Suitability	2023-05-17	Withdrawn	Neuheit Pharma Technologies Pvt Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2021-P-1175 · 4 docket documents Felix Pharmaceuticals Pvt. Ltd. submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new animal drug application (ANADA) for a generic levothyroxine sodium oral solution for dogs, which would differ from the approved	Suitability	2021-10-28	Open	Felix Pharmaceuticals Pvt. Ltd.
Mason, Taylor & Colicchio - Citizen Petition (CP1) FDA-1997-N-0041 · 30 docket documents Mason, Taylor & Colicchio, a law firm representing a pharmaceutical manufacturer, filed this citizen petition requesting that the FDA rescind its August 14, 1997 determination that oral levothyroxine sodium products are "new drugs" requiring NDA approval under Federal Food, Drug, and Cosmetic Act se	Other	2009-01-24	Granted	—

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

Clinical Trials

70 trials from ClinicalTrials.gov — 1 recruiting, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Thyroid Hormone Replacement for Subclinical Hypothyroidism NCT01660126	Phase 4	Completed	NHS Greater Glasgow and Clyde	737	2014-05 → 2016-11-18
The TRUST Study - CardioVascular Imaging IMT NCT02832934	Phase 4	Completed	Insel Gruppe AG, University Hospital Bern	184	2016-06 → 2016-12
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg NCT00648557	Phase 1	Completed	Mylan Pharmaceuticals Inc	32	2003-01 → 2003-03
Thyroid Hormone Dose Adjustment in Pregnancy NCT00230802	N/A	Completed	Brigham and Women's Hospital	48	2005-07 → 2010-07
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism NCT00535561	Phase 1	Completed	Duzce University	—	2007-06 → 2007-09
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism NCT04288115	Phase 4	Completed	VA Office of Research and Development	52	2021-03-24 → 2022-12-31
Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics NCT03102177	Early Phase 1	Completed	Georgetown University	41	2011-05-31 → 2016-07-26
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome NCT01832753	N/A	Completed	Children's Hospital of Philadelphia	12	2013-01 → 2017-10-18
Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy NCT03115515	N/A	Completed	Medstar Health Research Institute	60	2011-08 → 2018-02

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 34 NDCs (11 brand, 23 generic)

Highest NADAC/Unit

$4.24

per ea

Lowest NADAC/Unit

$0.0362

per ea

Brand NDCs

Generic NDCs

Avg Brand: $4.21

Avg Generic: $0.0604

99% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60846081101UNITHROID 200 MCG TABLET	$4.24	EA	Brand	$0.0806	2026-06-17
60846081001UNITHROID 175 MCG TABLET	$4.23	EA	Brand	$0.0800	2026-06-17
60846080801UNITHROID 137 MCG TABLET	$4.23	EA	Brand	$0.0630	2026-06-17
60846080901UNITHROID 150 MCG TABLET	$4.22	EA	Brand	$0.0635	2026-06-17
60846080701UNITHROID 125 MCG TABLET	$4.22	EA	Brand	$0.0584	2026-06-17
60846080601UNITHROID 112 MCG TABLET	$4.21	EA	Brand	$0.0616	2026-06-17

Showing 6 of 34 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 24 NDCs (12 FSS, 12 Big4)

Lowest Price

$322.33

Highest Price

$398.56

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60846-0801-01UNITHROID 25MCG TAB	$392.77	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
60846-0801-01UNITHROID 25MCG TAB	$322.33	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
60846-0804-01UNITHROID 88MCG TAB	$394.34	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
60846-0804-01UNITHROID 88MCG TAB	$324.66	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
60846-0802-01UNITHROID 50MCG TAB	$393.03	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
60846-0802-01UNITHROID 50MCG TAB	$323.31	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027

Showing 6 of 24 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Unithroid (2024)

Total Spending

$4.1M

Total Claims

94,138

Beneficiaries

26,303

Avg Cost/Unit

$0.58

Spending Trend

$1.5M(2019)→$1.7M(2020)→$2.0M(2021)→$2.2M(2022)→$2.8M(2023)→$4.1M(2024)

YoY Change:+26.8%

5yr CAGR:+2.6%

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 LIMITEDLEVOTHYROXINE 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
Dec 20, 2018	SUPPL -8	View Letter (PDF)
Feb 14, 2008	SUPPL -4	View Letter (PDF)
Dec 22, 2004	SUPPL -3	View Letter (PDF)
Jun 24, 2004	SUPPL -2	View Letter (PDF)
Aug 21, 2000	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,AB2,AB3

0 patents0 exclusivities▴