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Ketorolac tromethamine - Generic Drug Details
What are the generic drug sources for ketorolac tromethamine and what is the scope of freedom to operate?
Ketorolac tromethamine
is the generic ingredient in nine branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Aurobindo Pharma Ltd, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, Lupin Ltd, and Omeros, and is included in fifty-one NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ketorolac tromethamine has sixty-four patent family members in twenty-five countries.
There are eighteen drug master file entries for ketorolac tromethamine. Fifty-one suppliers are listed for this compound.
Summary for ketorolac tromethamine
| International Patents: | 64 |
| US Patents: | 19 |
| Tradenames: | 9 |
| Applicants: | 28 |
| NDAs: | 51 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 51 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 64 |
| Patent Applications: | 6,478 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for ketorolac tromethamine |
| Drug Sales Revenues: | Drug sales revenues for ketorolac tromethamine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ketorolac tromethamine |
| DailyMed Link: | ketorolac tromethamine at DailyMed |
Recent Clinical Trials for ketorolac tromethamine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Medical Branch, Galveston | Phase 2 |
| Beth Israel Deaconess Medical Center | Phase 4 |
| Society for Obstetric Anesthesia and Perinatology | Phase 4 |
Recent Litigation for ketorolac tromethamine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan, Inc. v. Lupin Ltd. | 2011-12-30 |
| Allergan Inc. v. Apotex Inc. | 2007-05-21 |
| Allergan Inc. v. Alcon Inc. | 2004-08-24 |
Pharmacology for ketorolac tromethamine
| 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 ketorolac tromethamine
Synonyms for ketorolac tromethamine
| (+-)-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 |
| 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 (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 ketorolac tromethamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075631-001 | Jun 29, 2001 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| West-ward Pharms Int | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075299-001 | Nov 3, 1999 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| Mylan Labs Ltd | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 201155-002 | Aug 4, 2014 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| Gland Pharma Ltd | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076722-001 | Jul 27, 2004 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| >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 ketorolac tromethamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche Palo | TORADOL | ketorolac tromethamine | TABLET;ORAL | 019645-001 | Dec 20, 1991 | See Pricing | See Pricing |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | See Pricing | See Pricing |
| Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | See Pricing | See Pricing |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ketorolac tromethamine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2011513416 | See Pricing |
| Spain | 2382509 | See Pricing |
| China | 102497856 | See Pricing |
| Spain | 2657845 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ketorolac tromethamine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | C 2015 055 | Romania | See Pricing | 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 |
| 1534313 | 2015/071 | Ireland | See Pricing | 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 | 92923 | Luxembourg | See Pricing | 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 | See Pricing | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Major Patent Expirations 2019 - 2020
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ISSN: 2162-2639
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DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.