TRUSOPT Drug Patent Profile

When do Trusopt patents expire, and what generic alternatives are available?

Trusopt is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in TRUSOPT is dorzolamide hydrochloride. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trusopt

A generic version of TRUSOPT was approved as dorzolamide hydrochloride by RUBICON RESEARCH on October 28^th, 2008.

Summary for TRUSOPT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Drug Prices:	Drug price information for TRUSOPT
What excipients (inactive ingredients) are in TRUSOPT?	TRUSOPT excipients list
DailyMed Link:	TRUSOPT at DailyMed

See drug prices for TRUSOPT

See drug sales revenues for TRUSOPT

Recent Clinical Trials for TRUSOPT

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

Sponsor	Phase
University of Miami	Phase 3
National Eye Institute (NEI)	Phase 3
National Eye Institute (NEI)	Phase 1/Phase 2

See all TRUSOPT clinical trials

Paragraph IV (Patent) Challenges for TRUSOPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUSOPT	Ophthalmic Solution	dorzolamide hydrochloride	2%	020408	1	2005-10-11

US Patents and Regulatory Information for TRUSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994		DISCN	Yes	No

International Patents for TRUSOPT

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

Country	Patent Number	Title	Estimated Expiration
Austria	13632
Belgium	899314
Canada	1192560	2-TRIFLUORO-(OU TRICHLORO-)-ACETYLIMINO-3-METHYL- D.SUP.2-1,3,4-THIADIAZOLINE-5-SULFONAMIDES UTILISES POUR REDUIRE LA PRESSION INTRAOCULAIRE (2-TRIFLUORO-(OR TRICHLORO-)-ACETYLIMINO-3-METHYL- D.SUP.2-1,3,4-THIADIAZOLINE-5-SULFONAMIDES USED FOR REDUCING INTRAOCULAR PRESSURE)
Canada	1193546	PROCESSUS POUR REDUIRE LA PRESSION INTRAOCULAIRE (PROCESS FOR REDUCING INTRAOCULAR PRESSURE)
Switzerland	659585	ZUSAMMENSETZUNG ZUR VERRINGERUNG DES AUGENINNENDRUCKES.
Germany	3170818
Germany	3411104

Supplementary Protection Certificates for TRUSOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296879	96C0003	Belgium		PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219
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