ACULAR Drug Patent Profile

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

Acular is a drug marketed by Abbvie and Allergan and is included in three NDAs. There are eight patents protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acular

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

Summary for ACULAR

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	23
Patent Applications:	3,821
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACULAR
What excipients (inactive ingredients) are in ACULAR?	ACULAR excipients list
DailyMed Link:	ACULAR at DailyMed

See drug prices for ACULAR

See drug sales revenues for ACULAR

Recent Clinical Trials for ACULAR

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

Sponsor	Phase
Emory University	Early Phase 1
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	Phase 4

See all ACULAR clinical trials

Pharmacology for ACULAR

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ACULAR

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	AT	RX	Yes	Yes
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y

Expired US Patents for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992

International Patents for ACULAR

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

Country	Patent Number	Title	Estimated Expiration
Norway	884020
Denmark	174702
U.S.S.R.	946403	PROCESS FOR PRODUCING ESTERS OR SALTS OF 5-AROYL-1,2-DIHYDRO-3H-PYRROLO-(1,2-A)-PYRROL-1-CARBOXYLIC ACID
Japan	H01104023	PRESERVING SYSTEM FOR OPHTHALMIC MEDICINE
Denmark	307577
Japan	H0696542
Switzerland	641461	5-Aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acid derivatives

Supplementary Protection Certificates for ACULAR

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	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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 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	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
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