Ketotifen fumarate - Generic Drug Details

✉ Email this page to a colleague

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
Bausch & Lomb Incorporated	Phase 3
ORA, Inc.	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharma	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021066-002	Oct 19, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sentiss	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077958-001	Jul 26, 2007		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	CHILDREN'S ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996-002	Feb 11, 2015		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayshore Pharms Llc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	204059-001	Jun 1, 2020		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
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)	⤷ Sign Up
Singapore	177934	METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES	⤷ Sign Up
China	101420934	Methods for stabilizing oxidatively unstable compositions	⤷ Sign Up
Hong Kong	1210274	用於治療眼變態反應性的方法和眼科裝置 (METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.