ISTALOL Drug Patent Profile

When do Istalol patents expire, and when can generic versions of Istalol launch?

Istalol is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ISTALOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Istalol

A generic version of ISTALOL was approved as timolol maleate by MYLAN on June 8^th, 1990.

Summary for ISTALOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	4,318
Drug Prices:	Drug price information for ISTALOL
What excipients (inactive ingredients) are in ISTALOL?	ISTALOL excipients list
DailyMed Link:	ISTALOL at DailyMed

See drug prices for ISTALOL

See drug sales revenues for ISTALOL

Recent Clinical Trials for ISTALOL

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

Sponsor	Phase
Bp Consulting, Inc	Phase 4

See all ISTALOL clinical trials

Pharmacology for ISTALOL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for ISTALOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTALOL	Ophthalmic Solution	timolol maleate	0.5%	021516	1	2012-10-19

US Patents and Regulatory Information for ISTALOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	AT2	RX	Yes	Yes

Expired US Patents for ISTALOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004

International Patents for ISTALOL

See the table below for patents covering ISTALOL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4377052
China	1278162
World Intellectual Property Organization (WIPO)	9922715

Supplementary Protection Certificates for ISTALOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	2000C/001	Belgium		PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
0509752	C990041	Netherlands		PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752	SPC/GB99/043	United Kingdom		PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804