ACULAR LS Drug Patent Profile
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When do Acular Ls patents expire, and what generic alternatives are available?
Acular Ls is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has five patent family members in three countries.
The generic ingredient in ACULAR LS 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 Ls
A generic version of ACULAR LS was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
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Questions you can ask:
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Summary for ACULAR LS
International Patents: | 5 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 23 |
Patent Applications: | 4,893 |
Drug Prices: | Drug price information for ACULAR LS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACULAR LS |
What excipients (inactive ingredients) are in ACULAR LS? | ACULAR LS excipients list |
DailyMed Link: | ACULAR LS at DailyMed |
![ACULAR LS drug patent expirations Drug patent expirations by year for ACULAR LS](/p/graph/s/t/ACULAR_LS-patent-expirations.png)
![Drug Prices for ACULAR LS](/p/graph/drug-price/ACULAR+LS.png)
Recent Clinical Trials for ACULAR LS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Early Phase 1 |
Arthroplasty Foundation, Inc. | Phase 4 |
University of Louisville | Phase 4 |
Pharmacology for ACULAR LS
Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for ACULAR LS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACULAR LS | Ophthalmic Solution | ketorolac tromethamine | 0.4% | 021528 | 1 | 2005-01-28 |
US Patents and Regulatory Information for ACULAR LS
ACULAR LS is protected by four US patents.
Patents protecting ACULAR LS
Ketorolac tromethamine compositions for treating or preventing ocular pain
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
Patented Use: A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING
Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING OCULAR PAIN
Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING OCULAR PAIN AND/OR ENHANCING OCULAR COMFORT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | 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 | Y | ⤷ 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 | ||
>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 LS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACULAR LS
See the table below for patents covering ACULAR LS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2954642 | ⤷ Sign Up | |
Japan | H01104023 | PRESERVING SYSTEM FOR OPHTHALMIC MEDICINE | ⤷ Sign Up |
Canada | 1328614 | SYSTEME DE CONSERVATION DES COMPOSITIONS OPHTALMIQUES (PRESERVATIVE SYSTEM FOR OPHTHALMICS FORMULATIONS) | ⤷ Sign Up |
European Patent Office | 0306984 | PRESERVATIVE SYSTEM FOR OPHTALMIC FORMULATIONS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACULAR LS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | 76/2015 | Austria | ⤷ Sign Up | 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 | CA 2015 00072 | Denmark | ⤷ Sign Up | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |