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Generated: September 26, 2017
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.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 104 |
| Clinical Trials: see list | 7 |
| Patent Applications: see list | 4,641 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ACUVAIL at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| 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 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | |
Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ketorolac tromethamine | Opthalmic Solution | 0.45% | Acuvail | 8/24/2011 |
| ketorolac tromethamine | Opthalmic Solution | 0.45% | Acuvail | 8/23/2011 |
| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mexico | 2010009763 | ► Subscribe | |||||||||||||
| Brazil | PI0909100 | ► Subscribe | |||||||||||||
| Australia | 2009222016 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 2011127196 | ► Subscribe | |||||||||||||
| Austria | 538775 | ► Subscribe | |||||||||||||
| Israel | 207925 | ► Subscribe | |||||||||||||
| Australia | 2011237646 | ► Subscribe | |||||||||||||
| Japan | 2013523829 | ► Subscribe | |||||||||||||
| Denmark | 2446878 | ► Subscribe | |||||||||||||
| Canada | 2772622 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2015 | Austria | ► Subscribe | 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 | ||||||||||||
| 2015000111 | Germany | ► Subscribe | PRODUCT 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 | ||||||||||||
| 2015 00072 | Denmark | ► Subscribe | 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 | ||||||||||||
| C0090 | France | ► Subscribe | 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 | ||||||||||||
| 923 | Luxembourg | ► Subscribe | 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 | ||||||||||||
| 0784 | Netherlands | ► Subscribe | 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 | ||||||||||||
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Export unavailable in trial.
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Serving 500+ biopharmaceutical companies globally:
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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