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TIROSINT

NDA

LEVOTHYROXINE SODIUM | N021924 | IBSA INSTITUT BIOCHIMIQUE SA

15 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

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Today

12564565

Sep. 26, 2044

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
IBSA Institut Biochimique SA et al v. Teva Pharmaceutical USA, Inc. 1:2019cv02115	D. Del.	2019-11-08	Terminated 2020-01-03	—
IBSA Institut Biochimique, S.A. et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv00555	D. Del.	2018-04-13	Terminated 2019-09-10	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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.

VA Federal Supply Schedule

Government-negotiated contract prices | 27 NDCs (27 FSS)

Lowest Price

$50.83

Highest Price

$106.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71858-0005-04TIROSINT 0.013MG CAP	$103.60	FSS	IBSA Pharma Inc.	06/30/2026
71858-0010-04TIROSINT 0.025MG CAP	$103.35	FSS	IBSA Pharma Inc.	06/30/2026
71858-0012-04TIROSINT 37.5MCG CAP	$106.14	FSS	IBSA Pharma Inc.	06/30/2026
71858-0013-04TIROSINT 44MCG CAP	$105.64	FSS	IBSA Pharma Inc.	06/30/2026
82347-0015-04LEVOTHYROXINE NA 50MCG CAP	$50.83	FSS	Yaral Pharma, Inc.	04/30/2028
82347-0005-04LEVOTHYROXINE NA 13MCG CAP	$51.18	FSS	Yaral Pharma, Inc.	04/30/2028

Showing 6 of 27 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Tirosint (2024)

Total Spending

$16.6M

Total Claims

63,867

Beneficiaries

14,554

Avg Cost/Unit

$4.48

Spending Trend

$12.7M(2019)→$15.5M(2020)→$14.1M(2021)→$14.3M(2022)→$15.4M(2023)→$16.6M(2024)

YoY Change:-2.5%

5yr CAGR:+0.4%

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

4 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2022	SUPPL -21	View Letter (PDF)
Mar 12, 2012	SUPPL -6	View Letter (PDF)
Jan 9, 2008	SUPPL -2	View Letter (PDF)
Oct 23, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (15)

Sort:

#002 — 0.025MG

RLD

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