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NDA

ARTICAINE HYDROCHLORIDE | N218643 | THEA PHARMA INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2026

2027

2028

2029

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2032

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2034

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2039

Today

11096922

Mar. 27, 2039

11826347

Mar. 27, 2039

12403126

Mar. 27, 2039

Aug. 15, 2028

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 Chain4 active DMFs1 inactive

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

SCI PHARMTECH INCARTICAINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 118771996

SIEGFRIED EVIONNAZ SAARTICAINE HYDROCHLORIDE

DMF 159192002

ORGAPHARM SASARTICAINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 164692003

ZENTIVA KSARTICAINE HYDROCHLORIDE

DMF 202872007

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveARTICAINE HYDROCHLORIDE

DMF 201182006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 18, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 8% BASE

RLD

3 patents1 exclusivity▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 15, 2025

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11096922	Mar 27, 2039	—	—	Yes	U-4423	—
11826347	Mar 27, 2039	—	—	Yes	U-4423	—
12403126	Mar 27, 2039	—	—	Yes	U-4422	—

Exclusivities (1)

Code	Date	Status
NP	Aug 15, 2028	Active