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ACUVUE THERAVISION WITH KETOTIFEN

NDA

KETOTIFEN FUMARATE | N022388 | JOHNSON AND JOHNSON VISION CARE INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

Today

Mar. 27, 2028

Jun. 27, 2030

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 Chain0 active DMFs1 inactive

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

SIFAVITOR SRLInactiveKETOTIFEN

DMF 216872008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2022	ORIG -1	View Letter (PDF)
Feb 28, 2022	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 19MCG BASE

RLD

2 patents0 exclusivities▴

DRUG-ELUTING CONTACT LENS;OPHTHALMIC | Approved: Feb 25, 2022

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9474746	Mar 27, 2028	—	—	Yes	—	—
9962376	Jun 27, 2030	—	—	Yes	—	—