DrugPatentWatch Database Preview
ACULAR LS Drug Profile
When do Acular Ls patents expire, and what generic alternatives are available?
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-nine 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: | 60 |
| Clinical Trials: | 20 |
| Patent Applications: | 3,670 |
| 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 |
Pharmacology for ACULAR LS
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for ACULAR LS
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 |
| AK323643 |
| AKOS024386301 |
| AN-37166 |
| API0003085 |
| AS-15193 |
| 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 |
| CL23725 |
| CPD000058461 |
| CS-1933 |
| CTK8G0438 |
| D00813 |
| DivK1c_000836 |
| Dolac |
| DR002107 |
| Droal |
| EU-0100676 |
| F0001-2390 |
| FT-0630829 |
| Godek |
| HMS1570J20 |
| HMS1922K22 |
| HMS2051P06 |
| HMS2093M05 |
| HMS2097J20 |
| HMS2235N13 |
| HMS3262G13 |
| HMS3373M06 |
| HMS3393P06 |
| HMS3655E15 |
| 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; traceable to USP and PhEur |
| 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 |
| SAM001246596 |
| SCHEMBL5036 |
| SMR000058461 |
| SPBio_001596 |
| SPBio_003017 |
| Spectrum_001578 |
| SPECTRUM1503925 |
| Spectrum2_001598 |
| Spectrum3_001975 |
| Spectrum4_000215 |
| Spectrum5_001273 |
| SPRIX |
| SR-01000946595 |
| SR-01000946595-1 |
| ST51037313 |
| Syntex |
| Tora-Dol |
| Toradol |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 | ➤ Try a Free Trial | ➤ Try a Free 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 | ➤ Try a Free Trial |
International Patents for ACULAR LS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3217937 | ➤ Try a Free Trial |
| Canada | 2468664 | ➤ Try a Free Trial |
| Canada | 2967362 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ACULAR LS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0784 | Netherlands | ➤ Try a Free Trial | 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 |
| 2015 00072 | Denmark | ➤ Try a Free 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 |
| C0090 | France | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
