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Ketorolac tromethamine - Generic Drug Details

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What are the generic drug sources for ketorolac tromethamine and what is the scope of ketorolac tromethamine freedom to operate?

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-seven NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has seventy-two patent family members in twenty-five countries.

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

Summary for ketorolac tromethamine

International Patents:	72
US Patents:	20
Tradenames:	8
Applicants:	25
NDAs:	47
Drug Master File Entries:	18
Suppliers / Packagers:	57
Bulk Api Vendors:	56
Clinical Trials:	55
Patent Applications:	5,960
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ketorolac tromethamine
DailyMed Link:	ketorolac tromethamine at DailyMed

Pharmacology for ketorolac tromethamine

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

Medical Subject Heading (MeSH) Categories for ketorolac tromethamine

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

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
Sandoz Inc	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	076271-001	Oct 6, 2004		DISCN	No	No
Amphastar Pharm	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	076209-002	Jul 21, 2004	AP	RX	No	No
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes
Gland Pharma Ltd	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	076722-002	Jul 27, 2004		DISCN	No	No

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Expired US Patents for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003

Non-Orange Book US Patents for ketorolac tromethamine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,267,827	Therapeutic compositions for intranasal administration which include KETOROLAC
7,476,689	Therapeutic compositions for intranasal administration which include KETOROLAC

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International Patents for ketorolac tromethamine

Country	Document Number	Estimated Expiration
European Patent Office	2257275
Germany	69206345
Canada	2534484
Australia	2010289618

Supplementary Protection Certificates for ketorolac tromethamine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
923	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
/2015	Austria		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		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		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