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TIMOPTIC Drug Patent Profile

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Which patents cover Timoptic, and when can generic versions of Timoptic launch?

Timoptic is a drug marketed by Valeant Pharms Intl and Valeant Pharms Llc and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Timoptic

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

Summary for TIMOPTIC

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	17
Patent Applications:	6,377
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIMOPTIC
Drug Sales Revenues:	Drug sales revenues for TIMOPTIC
What excipients (inactive ingredients) are in TIMOPTIC?	TIMOPTIC excipients list
DailyMed Link:	TIMOPTIC at DailyMed

See drug prices for TIMOPTIC

Recent Clinical Trials for TIMOPTIC

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

Sponsor	Phase
Bausch & Lomb Incorporated	N/A
University of California, San Diego	N/A
Inotek Pharmaceuticals Corporation	Phase 3

See all TIMOPTIC clinical trials

Pharmacology for TIMOPTIC

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

Anatomical Therapeutic Chemical (ATC) Classes for TIMOPTIC

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TIMOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms Intl	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	No
Valeant Pharms Intl	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	AT3	RX	Yes	Yes
Valeant Pharms Intl	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	AT1	RX	Yes	No

Expired US Patents for TIMOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982
Valeant Pharms Intl	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982
Valeant Pharms Intl	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982

International Patents for TIMOPTIC

Country	Patent Number	Estimated Expiration
Yugoslavia	125469
France	2070067
Finland	55507

Supplementary Protection Certificates for TIMOPTIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0227494	95C0013	Belgium		PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
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	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