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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
Fuji
Mallinckrodt
Cipla
Harvard Business School
Boehringer Ingelheim
Chinese Patent Office
US Army

Generated: July 17, 2018

DrugPatentWatch Database Preview

ACULAR LS Drug Profile

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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-seven suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Drug patent expirations by year for ACULAR LS
Medical Subject Heading (MeSH) Categories for ACULAR LS
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
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
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 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT 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 ACULAR LS
Drugname Dosage Strength RLD Date
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Supplementary Protection Certificates for ACULAR LS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
923 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
2015000111 Germany ➤ Sign Up 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
/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
2015 00072 Denmark ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Baxter
UBS
Farmers Insurance
Merck
Argus Health
AstraZeneca
Dow
Covington

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.