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THYRO-TABS

NDA

LEVOTHYROXINE SODIUM | N021116 | ALVOGEN 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

5 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	DeniedDecision letter not yet read	—
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	WithdrawnUnverified summary	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.
Citizen Petition Request from LACHMAN CONSULTANT SERVICES INC FDA-2015-P-0403 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Lloyd's LEVOTHROID (levothyroxine sodium) Tablets in twelve dosage strengths, approved under NDA 021116, were voluntarily withdrawn for safety or effectiveness reasons, and i	505(q)	2015-02-06	GrantedUnverified summary	—
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	GrantedUnverified summary	—

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

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 | 23 NDCs

Highest NADAC/Unit

$0.0999

per ea

Lowest NADAC/Unit

$0.0357

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47781067190LEVOTHYROXINE 300 MCG TABLET	$0.0999	EA	Generic	—	2026-08-19
47781066890LEVOTHYROXINE 200 MCG TABLET	$0.0802	EA	Generic	—	2026-08-19
47781066810LEVOTHYROXINE 200 MCG TABLET	$0.0802	EA	Generic	—	2026-08-19
47781066590LEVOTHYROXINE 175 MCG TABLET	$0.0765	EA	Generic	—	2026-08-19
47781066510LEVOTHYROXINE 175 MCG TABLET	$0.0765	EA	Generic	—	2026-08-19
47781065910LEVOTHYROXINE 137 MCG TABLET	$0.0627	EA	Generic	—	2026-08-19

Showing 6 of 23 NDCs.

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

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

8 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2023	SUPPL -27	View Letter (PDF)
Apr 15, 2022	SUPPL -23	View Letter (PDF)
Dec 16, 2021	SUPPL -21	View Letter (PDF)
Apr 26, 2019	SUPPL -17	View Letter (PDF)
Sep 1, 2017	SUPPL -13	View Letter (PDF)
May 24, 2016	SUPPL -16	View Letter (PDF)
Mar 23, 2006	SUPPL -6	View Letter (PDF)
Oct 24, 2002	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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB1,AB2,AB3,AB4

0 patents0 exclusivities▴