Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Dow
Moodys
Mallinckrodt
McKinsey

Last Updated: October 21, 2019

DrugPatentWatch Database Preview

ACULAR LS Drug Profile

See Plans and Pricing

« Back to Dashboard

Which patents cover Acular Ls, and when can generic versions of Acular Ls launch?

Acular Ls is a drug marketed by Allergan and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in three countries.

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

Drug patent expirations by year for ACULAR LS
Drug Prices for ACULAR LS

See drug prices for ACULAR LS

Recent Clinical Trials for ACULAR LS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Arthroplasty Foundation, Inc.Phase 4
University of LouisvillePhase 4
Chang Gung Memorial HospitalPhase 4

See all ACULAR LS clinical trials

Recent Litigation for ACULAR LS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan, Inc. v. Lupin Ltd.2011-12-30
Roche Palo Alto LLC v. Apotex, Inc.
Syntex USA LLC v. Apotex Inc.

See all ACULAR LS litigation

Synonyms for ACULAR LS
(+-)-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 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
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 ACULAR LS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes   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
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes   Start Trial   Start Trial Y   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
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes   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   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for ACULAR LS
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.40% ➤ Subscribe   Start Trial

Supplementary Protection Certificates for ACULAR LS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 2015/071 Ireland   Start Trial 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 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 C 2015 055 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Harvard Business School
Johnson and Johnson
Colorcon
AstraZeneca

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.