Viewing data from:

SOOLANTRA

NDA

IVERMECTIN | N206255 | GALDERMA LABORATORIES LP

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

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Today

Mar. 13, 2034

Mar. 13, 2034

Mar. 13, 2034

Mar. 13, 2034

Mar. 13, 2034

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
Galderma Laboratories LP et al. v. Teva Pharmaceuticals USA, Inc. 1:2017cv01783 5 patentsANDA 210019ivermectin	D. Del.	2017-12-11	Terminated 2020-03-12	—
Galderma Laboratories LP et al v. Actavis Laboratories UT Inc et al 3:2017cv01076 6 patentsANDA 210019ivermectin	TXND	2017-04-21	Terminated 2017-12-11	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Soolantra (2023)

Total Spending

$2.0M

Total Claims

2,721

Beneficiaries

1,267

Avg Cost/Unit

$15.21

Spending Trend

$11.0M(2019)→$7.5M(2020)→$7.5M(2021)→$3.2M(2022)→$2.0M(2023)

YoY Change:+5.7%

5yr CAGR:+4.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs2 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

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
Oct 17, 2022	SUPPL -5	View Letter (PDF)
Oct 17, 2022	SUPPL -9	View Letter (PDF)
Apr 23, 2018	SUPPL -4	View Letter (PDF)
Dec 24, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

5 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 19, 2014

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9089587	Mar 13, 2034	—	—	—	—
9233117	Mar 13, 2034	—	—	—	—
9233118	Mar 13, 2034	—	—	—	—
9782425	Mar 13, 2034	—	—	—	—
10206939	Mar 13, 2034	—	—	—	—