DrugPatentWatch Database Preview
ACULAR LS Drug Profile
Which patents cover Acular Ls, and when can generic versions of Acular Ls launch?
Acular Ls is a drug marketed by Allergan and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has four 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. Fifty-one suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for ACULAR LS
| International Patents: | 4 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 20 |
| Patent Applications: | 4,000 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACULAR LS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACULAR LS |
| DailyMed Link: | ACULAR LS at DailyMed |
Recent Clinical Trials for ACULAR LS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Arthroplasty Foundation, Inc. | Phase 4 |
| University of Louisville | Phase 4 |
| Chang Gung Memorial Hospital | Phase 4 |
Recent Litigation for ACULAR LS
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan, Inc. v. Lupin Ltd. | 2011-12-30 |
| Roche Palo Alto LLC v. Apotex, Inc. | |
| Syntex USA LLC v. Apotex Inc. |
Pharmacology for ACULAR LS
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Synonyms for ACULAR LS
| (+-)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) |
| (+/-)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid tris salt |
| (+/-)-Ketorolac Tromethamine Salt |
| 103K074 |
| 1H-Pyrrolizine-1-carboxylic acid, 5-benzoyl-2,3-dihydro, (+-)-, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) |
| 1H-Pyrrolizine-1-carboxylic acid, 5-benzoyl-2,3-dihydro, (+/-)-, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol(1:1) |
| 2-amino-2-(hydroxymethyl)propane-1,3-diol 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylate |
| 2-amino-2-(hydroxymethyl)propane-1,3-diol; 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid |
| 2-amino-2-(hydroxymethyl)propane-1,3-diol;5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid |
| 5-(phenylcarbonyl)-2,3-dihydropyrrolizinecarboxylic acid, 2-amino-2-(hydroxyme thyl)propane-1,3-diol |
| 74103-07-4 |
| AB2000191 |
| ABP001027 |
| AC1L36LM |
| Acular |
| Acular (TN) |
| Acular PF |
| Acular Preservative Free |
| Acular;Ketorolac tris salt;Toradol |
| Acuvail |
| AKOS024386301 |
| AN-37166 |
| API0003085 |
| AS-15193 |
| BCP02917 |
| BCP0726000301 |
| BCP9000811 |
| BG0547 |
| BPBio1_000922 |
| BPPC |
| BSPBio_000838 |
| BSPBio_003575 |
| BWHLPLXXIDYSNW-UHFFFAOYSA-N |
| C-21261 |
| C15H13NO3.C4H11NO3 |
| C19H24N2O6 |
| CCG-101006 |
| CCG-39376 |
| CHEBI:6130 |
| CHEMBL1201124 |
| CK0012 |
| CPD000058461 |
| CS-1933 |
| CTK8G0438 |
| D00813 |
| DivK1c_000836 |
| Dolac |
| Droal |
| EU-0100676 |
| F0001-2390 |
| FT-0630829 |
| Godek |
| HMS1570J20 |
| HMS1922K22 |
| HMS2051P06 |
| HMS2093M05 |
| HMS2097J20 |
| HMS2235N13 |
| HMS3262G13 |
| HMS3373M06 |
| HMS3393P06 |
| HMS3655E15 |
| HMS3714J20 |
| HMS502J18 |
| HY-B0138 |
| IDI1_000836 |
| K 1136 |
| K0053 |
| KBio1_000836 |
| KBio2_002058 |
| KBio2_004626 |
| KBio2_007194 |
| KBio3_002953 |
| KBioGR_000849 |
| KBioSS_002058 |
| Ketorolac (Toradol) |
| Ketorolac (tromethamine salt) |
| Ketorolac Rinse |
| Ketorolac tris salt |
| Ketorolac tris salt, >=99%, crystalline |
| Ketorolac trometamol |
| Ketorolac Trometamol 1.0 mg/ml in Methanol (as free acid) |
| Ketorolac trometamol for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Ketorolac trometamol, European Pharmacopoeia (EP) Reference Standard |
| Ketorolac tromethamine |
| Ketorolac tromethamine (USP) |
| Ketorolac tromethamine [USAN:USP] |
| Ketorolac tromethamine [USAN] |
| Ketorolac tromethamine ophthalmic solution |
| Ketorolac tromethamine salt |
| Ketorolac Tromethamine, Pharmaceutical Secondary Standard; Certified Reference Material |
| Ketorolac Tromethamine, United States Pharmacopeia (USP) Reference Standard |
| ketorolac; tris buffer |
| KS-00000XLJ |
| Lixidol |
| Lopac0_000676 |
| LP00676 |
| LS-139095 |
| MFCD00887595 |
| MLS000069689 |
| MLS001401455 |
| MLS002222310 |
| MolPort-003-666-507 |
| NC00256 |
| NCGC00016159-02 |
| NCGC00016159-03 |
| NCGC00016159-04 |
| NCGC00094036-01 |
| NCGC00094036-02 |
| NCGC00094036-03 |
| NCGC00261361-01 |
| NINDS_000836 |
| NSC-758637 |
| NSC758637 |
| O440 |
| Pharmakon1600-01503925 |
| Prestwick0_000929 |
| Prestwick1_000929 |
| Prestwick2_000929 |
| Prestwick3_000929 |
| Q-201269 |
| RL04801 |
| ROX-828 |
| ROX-888 |
| RS-37619 |
| SAM001246596 |
| SCHEMBL5036 |
| SMR000058461 |
| SPBio_001596 |
| SPBio_003017 |
| Spectrum_001578 |
| SPECTRUM1503925 |
| Spectrum2_001598 |
| Spectrum3_001975 |
| Spectrum4_000215 |
| Spectrum5_001273 |
| SPRIX |
| SR-01000075948 |
| SR-01000075948-1 |
| SR-01000075948-6 |
| SR-01000075948-8 |
| SR-01000946595 |
| SR-01000946595-1 |
| ST51037313 |
| SW197293-4 |
| Syntex |
| Tora-Dol |
| Toradol |
| Toradol (TN) |
| Toratex |
| Tox21_500676 |
| Tromethamine ketorolac |
US Patents and Regulatory Information for ACULAR LS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ACULAR LS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Ophthalmic Solution | 0.40% | ➤ Subscribe | Start Trial |
International Patents for ACULAR LS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2967362 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016077726 | Start Trial |
| Canada | 2468664 | Start Trial |
| European Patent Office | 3217937 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ACULAR LS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 15C0090 | France | Start Trial | 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 | 92923 | Luxembourg | Start Trial | 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 | 76/2015 | Austria | Start Trial | 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 | 2015/071 | Ireland | Start Trial | PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | CA 2015 00072 | Denmark | Start Trial | 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 | C 2015 055 | Romania | Start Trial | PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
