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ADQUEY

NDA

DIFAMILAST | N219474 | ACROTECH BIOPHARMA INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

RE46792

Mar. 1, 2028

10588893

Dec. 31, 2036

NCE

Feb. 12, 2031

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

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

HEFEI TIANRUI PHARMACEUTICAL CHEMICAL CO LTDDIFAMILAST

DMF 421682025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

2 patents1 exclusivity▴

OINTMENT;TOPICAL | Approved: Feb 12, 2026

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46792	Mar 1, 2028	—	Yes	Yes		—
10588893	Dec 31, 2036	—	Yes	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	Feb 12, 2031	Active