acuvail Drug Patent Profile

✉ Email this page to a colleague

Which patents cover Acuvail, and what generic alternatives are available?

Acuvail is a drug marketed by Abbvie 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. 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 Acuvail

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

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for acuvail?
What are the global sales for acuvail?
What is Average Wholesale Price for acuvail?

Summary for acuvail

International Patents:	63
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	11
Patent Applications:	4,893
Drug Prices:	Drug price information for acuvail
What excipients (inactive ingredients) are in acuvail?	acuvail excipients list
DailyMed Link:	acuvail at DailyMed

Drug patent expirations by year 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
National Eye Institute (NEI)	Phase 1

See all acuvail clinical trials

Pharmacology for acuvail

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

Paragraph IV (Patent) Challenges for ACUVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACUVAIL	Ophthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24

US Patents and Regulatory Information for acuvail

acuvail is protected by four US patents.

Patents protecting acuvail

Ketorolac tromethamine compositions for treating ocular pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions for delivery of therapeutics into the eyes and methods for making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for acuvail

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for acuvail

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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Poland	2446878		⤷ Sign Up
South Korea	20100130989	KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN	⤷ Sign Up
Spain	2332049		⤷ Sign Up
Australia	2011237646	Ketorolac compositions for corneal wound healing	⤷ Sign Up
China	102497856	Ketorolac tromethamine compositions for treating or preventing ocular pain	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acuvail

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland	⤷ Sign Up	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	15C0090	France	⤷ Sign Up	PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	C 2015 055	Romania	⤷ Sign Up	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	122015000111	Germany	⤷ Sign Up	PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	CR 2015 00072	Denmark	⤷ Sign Up	PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description