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ACUVAIL Drug Profile
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When do Acuvail patents expire, and what generic alternatives are available?
This drug has fifty-eight patent family members in twenty-three countries.
The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for ACUVAIL
| International Patents: | 58 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,608 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ACUVAIL at DailyMed |
Pharmacology for ACUVAIL
| 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 ACUVAIL
Synonyms for ACUVAIL
| (+-)-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 LS |
| Acular PF |
| Acular Preservative Free |
| Acular;Ketorolac tris salt;Toradol |
| 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 ACUVAIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | 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 |
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Paragraph IV (Patent) Challenges for ACUVAIL
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Opthalmic Solution | 0.45% | ➤ Subscribe | 2011-08-24 |
| ➤ Subscribe | Opthalmic Solution | 0.45% | ➤ Subscribe | 2011-08-23 |
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International Patents for ACUVAIL
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 101560429 | ➤ Try a Free Trial |
| China | 103976943 | ➤ Try a Free Trial |
| Japan | 2013523829 | ➤ Try a Free Trial |
| Brazil | PI0909100 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ACUVAIL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| 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 |
| /2015 | Austria | ➤ Try a Free 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 |
| 2015000111 | Germany | ➤ Try a Free Trial | PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
