ACULAR Drug Patent Profile
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When do Acular patents expire, and what generic alternatives are available?
Acular is a drug marketed by Abbvie and Allergan and is included in three NDAs. There are eight patents protecting this drug.
The generic ingredient in ACULAR 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 Acular
A generic version of ACULAR was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
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Summary for ACULAR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Clinical Trials: | 23 |
| Patent Applications: | 4,893 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACULAR |
| What excipients (inactive ingredients) are in ACULAR? | ACULAR excipients list |
| DailyMed Link: | ACULAR at DailyMed |
Recent Clinical Trials for ACULAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Early Phase 1 |
| University of Louisville | Phase 4 |
| Arthroplasty Foundation, Inc. | Phase 4 |
Pharmacology for ACULAR
| Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for ACULAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ACULAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACULAR
See the table below for patents covering ACULAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | 1117313 | DERIVATI DELL'ACIDO PIRROL-1-CARBOSSILICO E PROCEDIMENTO PER LA LORO PREPARAZIONE | ⤷ Sign Up |
| Norway | 175404 | ⤷ Sign Up | |
| Finland | 884160 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACULAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 122015000111 | Germany | ⤷ Sign Up | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | 92923 | Luxembourg | ⤷ Sign Up | 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 | ⤷ 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
ISSN: 2162-2639
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