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Last Updated: April 27, 2024

Ketotifen fumarate - Generic Drug Details

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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.

Seventeen 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:	17
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	12
Patent Applications:	1,545
Formulation / Manufacturing:	see details
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
ORA, Inc.	Phase 3
EyeMax, LLC	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077354-001	May 9, 2006		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sentiss	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077958-001	Jul 26, 2007		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alcon Pharma	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021066-002	Oct 19, 2006		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bayshore Pharms Llc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	204059-001	Jun 1, 2020		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996-001	Dec 1, 2006		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ketotifen fumarate

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Country	Patent Number	Title	Estimated Expiration
China	101541303	Methods and ophthalmic devices used in the treatment of ocular allergies	⤷ Try a Trial
Russian Federation	2012125612	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ	⤷ Try a Trial
Canada	2908828	COMPOSITIONS OPHTALMIQUES STABILISEES COMPRENANT DES COMPOSANTS INSTABLES SUR LE PLAN OXYDATIF (METHODS FOR STABILIZING OXIDATIVELY UNSTABLE COMPOSITIONS)	⤷ Try a Trial
South Korea	20140083056	STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS	⤷ Try a Trial
Taiwan	200808355	Methods for stabilizing oxidatively unstable compositions	⤷ Try a Trial
European Patent Office	3210594	PROCÉDÉS ET DISPOSITIFS OPHTALMIQUES UTILISÉS DANS LE TRAITEMENT D'ALLERGIES OCULAIRES (METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES)	⤷ Try a Trial
Taiwan	I424844		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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