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ENSACOVE

NDA

ENSARTINIB HYDROCHLORIDE | N218171 | XCOVERY HOLDINGS INC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Feb. 9, 2029

Nov. 29, 2031

Jun. 18, 2029

Jun. 1, 2037

NCE

Dec. 18, 2029

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2026	SUPPL -3	View Letter (PDF)
Jan 9, 2026	SUPPL -2	View Letter (PDF)
Dec 19, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

4 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Dec 18, 2024

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8551995	Feb 9, 2029	—	Yes	—	—	—
9126947	Nov 29, 2031	—	Yes	—	—	—
9296724	Jun 18, 2029	—	Yes	—		—
10899744	Jun 1, 2037	—	Yes	—		—

Exclusivities (1)

Code	Date	Status
NCE	Dec 18, 2029	Active

#002 — EQ 100MG BASE

RLD

4 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Dec 18, 2024