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SKLICE

NDA

IVERMECTIN | N202736 | ARBOR PHARMACEUTICALS LLC

1 strength0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Arbor Pharmaceuticals, LLC v. Teva Pharmaceuticals USA, Inc. 1:2019cv00053 2 patentsANDA 212485ivermectin lotion	D. Del.	2019-01-09	Terminated 2019-09-10	—
Arbor Pharmaceuticals, LLC v. Taro Pharmaceuticals U.S.A., Inc. et al 1:2017cv09846 2 patentsANDA 210720ivermectin lotion	S.D.N.Y.	2017-12-15	Terminated 2020-02-06	—

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

Citizen Petitions

8 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Argenta FDA-2025-P-7371 · 5 docket documents Argenta filed a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Animal Drug Application (ANADA) for a generic ivermectin 1.0% oral liquid for horses. The proposed product differs from the reference listed n	Suitability	2025-12-29	Denied	Argenta
Citizen Petition from America's Frontline Doctors FDA-2025-P-1981 · 3 docket documents Dr. Simone Gold on behalf of America's Frontline Doctors filed this citizen petition under 21 C.F.R. § 10.30 and 21 U.S.C. § 353(b)(3) requesting that the FDA initiate rulemaking to switch ivermectin oral tablets from prescription-only to over-the-counter status for its FDA-approved indications of i	Other	2025-06-27	Open	America's Frontline Doctors
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-0048 · 10 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Ivermectin Tablets at 9 mg and 12 mg strengths, which would provide convenient higher-dose al	Suitability	2025-01-07	Granted	Senores Pharmaceuticals, Inc.
Attachment 1 Heartgard Plus (ivermectin/pyrantel) Chewable Labeling Informati... FDA-1998-P-0118 · 4 docket documents Phoenix Scientific Inc. filed a petition requesting that the FDA find Heartgard Plus chewable tablets suitable for approval, with the petition addressing labeling information for this combination product containing ivermectin and pyrantel. The submission pertains to regulatory approval pathways for	Suitability	2017-01-17	Granted	Phoenix Scientific Inc.
Citizen Petition from SmartVet Holdings Inc FDA-2016-P-1963 · 3 docket documents SmartVet Holdings, Inc., through its consultant Schafer Veterinary Consultants, LLC, filed a suitability petition requesting permission to submit an Abbreviated New Animal Drug Application for a different strength formulation of ivermectin pour-on, specifically 15 mg/mL instead of the 5 mg/mL concen	Other	2016-07-11	Open	SmartVet Holdings Inc
PetaStrip LLC - Citizen Petition FDA-2013-P-1512 · 3 docket documents PetaStrip, LLC submitted a suitability 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 soluble film dosage form of ivermectin for canines, with the same active ingredient amount, dosag	Other	2013-12-11	Denied	—
PetaStrip LLC - Citizen Petition FDA-2013-P-1511 · 3 docket documents PetaStrip, LLC filed a Suitability Petition under section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application for a soluble film formulation of ivermectin for cats, a different dosage form than the pioneer product Heartguard®	Other	2013-12-11	Denied	—
Con Vet GmbH & Co. KG (Veterinary Consulting Group) - Citizen Peition FDA-2012-P-0313 · 3 docket documents ConVet GmbH & Co. KG submitted a suitability petition under Section 512(n)(3) requesting FDA approval to file an abbreviated new animal drug application (ANADA) for a generic oral ivermectin product for horses in a flavored dissolvable thin film delivery strip form, which differs from the reference	Other	2012-04-24	Denied	—

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

Clinical Trials

89 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 73 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Analysis of the Microbiome in Rosacea NCT04108897	Early Phase 1	Active	Johns Hopkins University	150	2019-09-17 → 2027-09
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis NCT03876262	Phase 3	Active	Medicines Development for Global Health	323	2021-05-03 → 2026-01-01
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment NCT04351347	Phase 2/3	Recruiting	Tanta University	300	2020-06-16 → 2030-12-01
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination NCT01586169	N/A	Completed	Centre d'Appui à la lutte contre la Maladie	3,000	2010-02 → 2010-02
Lymphatic Filariasis (LF) in Ivory Coast NCT02974049	N/A	Completed	University Hospitals Cleveland Medical Center	189	2015-01 → 2018-09-25
Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis NCT01570504	Phase 3	Completed	Centro per le Malattie Tropicali	312	2013-03 → 2018-06-08
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study NCT02511353	Phase 2	Completed	Liverpool School of Tropical Medicine	141	2015-07 → 2016-07
Twice Yearly Treatment for the Control of LF NCT03036059	Phase 4	Completed	Noguchi Memorial Institute for Medical Research	1,462	2017-05-19 → 2019-12-08
Ivermectin Solution Bioequivalence Study - With Food (Repeat)NCT00921219	Phase 1	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	34	2005-09 → 2005-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.2873

per gm

Lowest NADAC/Unit

$0.2873

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24338018504SKLICE 0.5% LOTION	$0.2873	GM	Brand	$1.28	2026-06-17

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

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

HOVIONE PHARMASCIENCE LTDIVERMECTIN USP

DMF 213952008

ZHEJIANG HISUN PHARMACEUTICAL CO LTDIVERMECTIN USP

DMF 216242008

INDUSTRIALE CHIMICA SRLIVERMECTIN PH. FUR.

DMF 364942021

HEBEI MEIHE PHARMACEUTICAL CO LTDIVERMECTIN

DMF 385532023

HAIMEN PHARMACEUTICAL FACTORYInactiveIVERMECTIN, NON-STERILE BULK DRUG

DMF 127551997

SHANGHAI TONGREN PHARMACEUTICAL CO LTDInactiveIVERMECTIN

DMF 130371998

DELTA TECH LTDInactiveIVERMECTIN

DMF 176732004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2021	SUPPL -9	View Letter (PDF)
Oct 27, 2020	SUPPL -6	View Letter (PDF)
Jun 19, 2017	SUPPL -3	View Letter (PDF)
Feb 10, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLD

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Feb 7, 2012

No patent or exclusivity listings for this strength.