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Generated: November 21, 2018

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Ketorolac tromethamine - Generic Drug Details

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What are the generic sources for ketorolac tromethamine and what is the scope of ketorolac tromethamine patent protection?

Ketorolac tromethamine is the generic ingredient in eight branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Cycle Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharma Global, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Egalet Us Inc, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in forty-eight NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for ketorolac tromethamine. Fifty-nine suppliers are listed for this compound.

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
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 (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 ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland Pharma Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 204216-002 Nov 1, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
West-ward Pharms Int KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075772-002 Jul 21, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 201155-001 Aug 4, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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
Akorn KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203376-001 Feb 10, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Expired US Patents for ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Egalet Us Inc SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ACULAR PRESERVATIVE FREE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 020811-001 Nov 3, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for ketorolac tromethamine

Supplementary Protection Certificates for ketorolac tromethamine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
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 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
923 Luxembourg ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
QuintilesIMS
Cerilliant
Dow
UBS
Teva
McKinsey
Cantor Fitzgerald

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