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Johnson and Johnson
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QuintilesIMS
AstraZeneca
Queensland Health
Cantor Fitzgerald

Generated: May 24, 2019

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ACUVAIL Drug Profile

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When do Acuvail patents expire, and what generic alternatives are available?

Acuvail is a drug marketed by Allergan and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty patent family members in twenty-five countries.

The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Drug patent expirations by year for ACUVAIL
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
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
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 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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 Date
➤ Subscribe Opthalmic Solution 0.45% ➤ Subscribe ➤ Sign Up
➤ Subscribe Opthalmic Solution 0.45% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ACUVAIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 CR 2015 00072 Denmark ➤ Sign Up PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313 76/2015 Austria ➤ Sign Up 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 2015/071 Ireland ➤ Sign Up 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 ➤ Sign Up 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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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Deloitte
QuintilesIMS
Baxter
Mallinckrodt

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