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ACULAR LS Drug Profile

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

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. Forty-nine suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

US ANDA Litigation and Generic Entry Outlook for Acular Ls

A generic version of ACULAR LS was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for ACULAR LS

International Patents:	4
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,063
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACULAR LS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACULAR LS
DailyMed Link:	ACULAR LS at DailyMed

See drug prices for ACULAR LS

Recent Clinical Trials for ACULAR LS

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

Sponsor	Phase
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	Phase 4
Chang Gung Memorial Hospital	Phase 4

See all ACULAR LS clinical trials

Recent Litigation for ACULAR LS

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Allergan, Inc. v. Lupin Ltd.	2011-12-30
Syntex USA LLC v. Apotex Inc.	2005-06-24
Roche Palo Alto LLC v. Apotex, Inc.	2005-05-24

See all ACULAR LS litigation

Pharmacology for ACULAR LS

Drug Class	Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors

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

5-(phenylcarbonyl)-2,3-dihydropyrrolizinecarboxylic acid, 2-amino-2-(hydroxyme thyl)propane-1,3-diol

74103-07-4

AB2000191

ABP001027

Acular

Acular (TN)

Acular PF

Acular Preservative Free

Acular;Ketorolac tris salt;Toradol

Acuvail

AKOS024386301

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

DB-055837

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 tris salt;Ketorolac Tromethamine

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-tromethamine-salt

KS-00000XLJ

Lixidol

Lopac0_000676

LP00676

LS-139095

MFCD00887595

MLS000069689

MLS001401455

MLS002222310

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

Q27107089

ROX-828

ROX-888

RS-37619

s5698

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 ACULAR LS

Tradename	Dosage	Ingredient	NDA	Submissiondate
ACULAR LS	SOLUTION/DROPS;OPHTHALMIC	ketorolac tromethamine	021528	2005-01-28

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
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes			Y
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes

Expired US Patents for ACULAR LS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003

International Patents for ACULAR LS

Country	Patent Number	Estimated Expiration
Japan	H0696542
South Africa	8806757
Australia	626798
Ireland	60717
Hungary	199072
Israel	87724

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	300784	Netherlands		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
1534313	92923	Luxembourg		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	C 2015 055	Romania		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
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	122015000111	Germany		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	CA 2015 00072	Denmark		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