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ALAWAY

NDA

KETOTIFEN FUMARATE | N021996 | BAUSCH AND LOMB INC

2 strengths0 unique patents0 unique exclusivities

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Molino Mazzochi Siwik, LLP FDA-2006-P-0388 · 3 docket documents Rakoczy Molino Mazzochi Siwik LLP filed this citizen petition on behalf of an unnamed client requesting that the FDA deny any application to switch ketotifen fumarate ophthalmic solution 0.025% from prescription to over-the-counter status, arguing that the condition cannot be properly self-diagnosed	Other	2009-02-17	Open	Molino Mazzochi Siwik, LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

25 trials from ClinicalTrials.gov — 1 recruiting, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia NCT02484248	Phase 3	Recruiting	Craig A. Friesen, MD	40	2015-08 → 2027-04-01
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.NCT00770133	Phase 3	Completed	Bausch & Lomb Incorporated	141	2010-02 → 2010-06
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis NCT00432757	Phase 3	Completed	Vistakon Pharmaceuticals	120	2007-01 → 2007-03
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis NCT00133627	Phase 4	Completed	Novartis	229	2005-04 → 2005-10
Chronic Widespread Pain and White Blood Cell Activation NCT02984397	Phase 3	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	44	2016-12 → 2020-01
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis NCT00445874	Phase 3	Completed	Vistakon Pharmaceuticals	120	2007-02 → 2007-05
Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study NCT01553318	Phase 3	Completed	Indiana University	51	2012-03 → 2012-12
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)NCT00446056	Phase 4	Completed	Organon and Co	188	2003-09-25 → 2004-06-16
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis NCT00639587	Phase 3	Completed	UCB Pharma	149	2002-08 → 2003-03
Safety and Comfort of AL-4943A Ophthalmic Solution NCT01326858	Phase 1	Completed	Alcon Research	50	2011-04 → 2011-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$1.34

per ml

Lowest NADAC/Unit

$1.34

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00536125240EYE ITCH RELIEF 0.025% DROPS	$1.34	ML	Generic	—	2026-06-17
70000052201EYE ITCH RELIEF 0.025% DROPS	$1.34	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$6.07

Highest Price

$6.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00536-1252-40KETOTIFEN 0.025% SOLN,OPH	$6.07	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

4 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2021	SUPPL -17	View Letter (PDF)
Feb 12, 2015	SUPPL -8	View Letter (PDF)
Apr 25, 2007	SUPPL -1	View Letter (PDF)
Dec 28, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.025% BASE

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 1, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 0.025% BASE

RLD

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Feb 11, 2015