ACULAR PRESERVATIVE FREE Drug Patent Profile

When do Acular Preservative Free patents expire, and what generic alternatives are available?

Acular Preservative Free is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in ACULAR PRESERVATIVE FREE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acular Preservative Free

A generic version of ACULAR PRESERVATIVE FREE was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for ACULAR PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	4,765
DailyMed Link:	ACULAR PRESERVATIVE FREE at DailyMed

Recent Clinical Trials for ACULAR PRESERVATIVE FREE

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

Sponsor	Phase
Fundação Altino Ventura	Phase 2/Phase 3

See all ACULAR PRESERVATIVE FREE clinical trials

US Patents and Regulatory Information for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No

Expired US Patents for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997

International Patents for ACULAR PRESERVATIVE FREE

See the table below for patents covering ACULAR PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H047324
Italy	1162842	COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE
Italy	8367315
Australia	568072
New Zealand	203639	TOPICAL OPHTHALMIC COMPOSITIONS CONTAINING CERTAIN 5-AROYL-1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROL-1-YLCARBOXYLIC ACID DERIVATIVES
Japan	S58172314	USE OF PYRROLOPYROLE FOR EYE DISEASE TREATMENT
Germany	3310079

Supplementary Protection Certificates for ACULAR PRESERVATIVE FREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730