ACUVAIL Drug Patent Profile
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When do Acuvail patents expire, 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-six 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 16th, 1997.
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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: | 4,765 |
Drug Prices: | Drug price information for ACUVAIL |
What excipients (inactive ingredients) are in ACUVAIL? | ACUVAIL excipients list |
DailyMed Link: | ACUVAIL at DailyMed |
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 |
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.
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 | 8,992,952 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Abbvie | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | Yes | 9,192,571 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Abbvie | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | Yes | 8,512,717 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | 8,992,952 | ⤷ Subscribe |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103976943 | Ketorolac tromethamine compositions for treating or preventing ocular pain | ⤷ Subscribe |
Spain | 2566162 | ⤷ Subscribe | |
Poland | 1654002 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACUVAIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | 76/2015 | 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 |
1534313 | 92923 | 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 |
1534313 | 15C0090 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
ACUVAIL Market Analysis and Financial Projection Experimental
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