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Generated: November 23, 2017

DrugPatentWatch Database Preview

ACUVAIL Drug Profile

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What is the patent landscape for Acuvail, and what generic Acuvail alternatives are available?

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

This drug has fifty-five patent family members in twenty-one countries and six supplementary protection certificates in six countries.

The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
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;OPHTHALMIC022427-001Jul 22, 2009RXYesYes► Subscribe► SubscribeYY ► Subscribe
Allergan
ACUVAIL
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC022427-001Jul 22, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Allergan
ACUVAIL
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC022427-001Jul 22, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Allergan
ACUVAIL
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC022427-001Jul 22, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for ACUVAIL

Drugname Dosage Strength RLD Submissiondate
ketorolac tromethamineOpthalmic Solution0.45%Acuvail8/24/2011
ketorolac tromethamineOpthalmic Solution0.45%Acuvail8/23/2011

International Patent Family for Tradename: ACUVAIL

Country Document Number Estimated Expiration
Canada2772622► Subscribe
New Zealand588367► Subscribe
Japan5735968► Subscribe
New Zealand602445► Subscribe
Spain2566162► Subscribe
Spain2382509► Subscribe
Colombia6321226► Subscribe
China103976943► Subscribe
Hong Kong1149212► Subscribe
China102014869► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ACUVAIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0784Netherlands► SubscribePRODUCT 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
/2015Austria► SubscribePRODUCT 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
923Luxembourg► SubscribePRODUCT 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
C0090France► SubscribePRODUCT 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
2015 00072Denmark► SubscribePRODUCT 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
2015000111Germany► SubscribePRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cipla
Julphar
AstraZeneca
Citi
Moodys
Johnson and Johnson
Medtronic
Fuji
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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