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XEGLYZE

NDA

ABAMETAPIR | N206966 | LNHC INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

7812163

Oct. 28, 2026

10292389

Dec. 17, 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation NCT02062060	Phase 3	Completed	Dr. Reddy's Laboratories Limited	325	2014-02 → 2014-08
A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation NCT02060903	Phase 3	Completed	Dr. Reddy's Laboratories Limited	379	2014-02 → 2014-08
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation NCT02097485	Phase 2	Completed	Dr. Reddy's Laboratories Limited	50	2014-05 → 2014-10

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

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MYLAN LABORATORIES LTDInactiveABAMETAPIR

DMF 343052019

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 21, 2022	SUPPL -2	View Letter (PDF)
Jul 27, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.74%

RLD

2 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Jul 24, 2020

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7812163	Oct 28, 2026	—	—	Yes		—
10292389	Dec 17, 2034	—	—	Yes		—