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ACUVAIL Drug Profile

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

Acuvail is a drug marketed by Allergan and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acuvail

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

Summary for ACUVAIL

International Patents:	63
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	9
Patent Applications:	4,331
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACUVAIL
What excipients (inactive ingredients) are in ACUVAIL?	ACUVAIL excipients list
DailyMed Link:	ACUVAIL at DailyMed

See drug prices for ACUVAIL

Recent Clinical Trials for ACUVAIL

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

Sponsor	Phase
Allergan	Phase 1
Stephen J. Kim, MD	Phase 1
Emory University	Early Phase 1

See all ACUVAIL clinical trials

Pharmacology for ACUVAIL

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

ATC Classes for ACUVAIL

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

Paragraph IV (Patent) Challenges for ACUVAIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
ACUVAIL	SOLUTION/DROPS;OPHTHALMIC	ketorolac tromethamine	022427	2011-08-24

US Patents and Regulatory Information for ACUVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y	Y
Allergan	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y
Allergan	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y

International Patents for ACUVAIL

Country	Patent Number	Estimated Expiration
European Patent Office	2113246
Denmark	1654002
Croatia	P20180178

Supplementary Protection Certificates for ACUVAIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	300784	Netherlands		PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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	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