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Last Updated: November 20, 2019

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KETOROLAC TROMETHAMINE - Generic Drug Details

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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-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.

Drug Prices for KETOROLAC TROMETHAMINE

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Drug Sales Revenue Trends for KETOROLAC TROMETHAMINE

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Recent Clinical Trials for KETOROLAC TROMETHAMINE

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SponsorPhase
The University of Texas Medical Branch, GalvestonPhase 2
Beth Israel Deaconess Medical CenterPhase 4
Society for Obstetric Anesthesia and PerinatologyPhase 4

See all KETOROLAC TROMETHAMINE clinical trials

Recent Litigation for KETOROLAC TROMETHAMINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan, Inc. v. Lupin Ltd.2011-12-30
Allergan Inc. v. Apotex Inc.2007-05-21
Allergan Inc. v. Alcon Inc.2004-08-24

See all KETOROLAC TROMETHAMINE litigation

Pharmacology for KETOROLAC TROMETHAMINE
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 INJECTABLE;INJECTION ketorolac tromethamine 019698
TORADOL TABLET;ORAL ketorolac tromethamine 019645

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
Hospira KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 074993-001 Jan 27, 1999 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 074802-002 Jun 5, 1997 AP RX No Yes   Start Trial   Start Trial   Start Trial
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Apothecon KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075348-001 Nov 28, 2000 DISCN No No   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
>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 PRESERVATIVE FREE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 020811-001 Nov 3, 1997   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
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

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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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