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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 Inc, 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-seven patent family members in twenty-five countries.
There are eighteen drug master file entries for ketorolac tromethamine. Forty-seven suppliers are listed for this compound.
Summary for ketorolac tromethamine
| International Patents: | 67 |
| US Patents: | 19 |
| Tradenames: | 9 |
| Applicants: | 28 |
| NDAs: | 51 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 47 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 65 |
| Patent Applications: | 6,556 |
| 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 |
| Society for Obstetric Anesthesia and Perinatology | Phase 4 |
| Beth Israel Deaconess Medical Center | 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 |
| Syntex USA LLC v. Apotex Inc. | 2005-06-24 |
Pharmacology for ketorolac tromethamine
| 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 |
Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SPRIX | SPRAY, METERED;NASAL | ketorolac tromethamine | 022382 | 2012-03-12 |
| ACUVAIL | SOLUTION/DROPS;OPHTHALMIC | ketorolac tromethamine | 022427 | 2011-08-24 |
| ACULAR LS | SOLUTION/DROPS;OPHTHALMIC | ketorolac tromethamine | 021528 | 2005-01-28 |
| TORADOL | TABLET;ORAL | ketorolac tromethamine | 019645 | |
| TORADOL | INJECTABLE;INJECTION | ketorolac tromethamine | 019698 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 078299-002 | Jul 16, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | ACULAR PRESERVATIVE FREE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 020811-001 | Nov 3, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Apothecon | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075348-001 | Nov 28, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 074761-001 | May 16, 1997 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | 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 ketorolac tromethamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | Start Trial | Start Trial |
| Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | Start Trial | Start Trial |
| Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | Start Trial | Start Trial |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | Start Trial | Start Trial |
| Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ketorolac tromethamine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2010289618 | Start Trial |
| Japan | 6114182 | Start Trial |
| Japan | 5705552 | Start Trial |
| Poland | 2446878 | Start Trial |
| Poland | 2555770 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ketorolac tromethamine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 122015000111 | Germany | Start 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 |
| 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 | CR 2015 00072 | Denmark | Start Trial | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| 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 | 300784 | Netherlands | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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