Ketotifen fumarate - Generic Drug Details

What are the generic drug sources for ketotifen fumarate and what is the scope of freedom to operate?

Ketotifen fumarate is the generic ingredient in five branded drugs marketed by Johnson Johnson Visn, Bausch And Lomb, Bausch And Lomb Inc, Apotex Inc, Bayshore Pharms Llc, Sentiss, Alcon Pharma, and Alcon Pharms Ltd, and is included in eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketotifen fumarate has forty-four patent family members in fifteen countries.

Eighteen suppliers are listed for this compound.

Summary for ketotifen fumarate

International Patents:	44
US Patents:	2
Tradenames:	5
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	12
Patent Applications:	1,527
Drug Prices:	Drug price trends for ketotifen fumarate
What excipients (inactive ingredients) are in ketotifen fumarate?	ketotifen fumarate excipients list
DailyMed Link:	ketotifen fumarate at DailyMed

See drug prices for ketotifen fumarate

Recent Clinical Trials for ketotifen fumarate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking University Third Hospital	Phase 4
Eton Pharmaceuticals, Inc.	Phase 3
Bausch & Lomb Incorporated	Phase 3

See all ketotifen fumarate clinical trials

Pharmacology for ketotifen fumarate

Drug Class	Histamine-1 Receptor Inhibitor
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for ketotifen fumarate

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ketotifen fumarate

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for KETOTIFEN FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZADITOR	Ophthalmic Solution	ketotifen fumarate	0.025%	021066	1	2004-12-23

US Patents and Regulatory Information for ketotifen fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentiss	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077958-001	Jul 26, 2007		OTC	No	No
Alcon Pharms Ltd	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077200-001	Sep 2, 2008		OTC	No	Yes
Bayshore Pharms Llc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	204059-001	Jun 1, 2020		OTC	No	No
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No			Y
Bausch And Lomb	CHILDREN'S ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996-002	Feb 11, 2015		OTC	Yes	No
Apotex Inc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077354-001	May 9, 2006		OTC	No	No

International Patents for ketotifen fumarate

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1132176	用於使氧化不穩定的組合物穩定的方法 (STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS)
Japan	5275214
China	101541303	Methods and ophthalmic devices used in the treatment of ocular allergies
European Patent Office	2471507	Dispositifs ophtalmiques utilisés dans le traitement d'allergies oculaires (Ophthalmic devices used in the treatment of ocular allergies)
Russian Federation	2462234	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ (METHODS OF STABILISATION OF OXIDATIVELY UNSATABLE COMPOSITIONS)
Hungary	E033597