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ILEVRO Drug Profile

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When do Ilevro patents expire, and when can generic versions of Ilevro launch?

Ilevro is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-eight patent family members in twenty-six countries.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.

Summary for ILEVRO

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	4
Patent Applications:	1,001
Drug Prices:	Drug price information for ILEVRO
Drug Sales Revenues:	Drug sales revenues for ILEVRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILEVRO
Prior Art and Litigation Support	Order Prior Art and Litigation support for ILEVRO
DailyMed Link:	ILEVRO at DailyMed

Pharmacology for ILEVRO

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

Synonyms for ILEVRO

0J9L7J6V8C

2-(2-Amino-3-benzoyl-phenyl)-acetamide

2-(2-amino-3-benzoyl-phenyl)acetamide

2-(2-Amino-3-benzoylphenyl)acetamide

2-[2-amino-3-(benzoyl)phenyl]acetamide

2-[2-amino-3-(phenylcarbonyl)phenyl]acetamide

2-amino-3-benzoyl-benzeneacetamide

2-Amino-3-benzoyl-phenylacetamide

2-Amino-3-benzoylbenzeneacetamide

281N728

78281-72-8

A26218

AB0031799

AB01274763_02

AB01274763-01

AB1008448

AC-6949

AC1L45MC

AC1Q4ZKX

ACT02914

AHR 9434

AHR-9434

AK323236

AKOS005146108

AL 6515

AL-6515

Amfenac amide

AN-606

API0003541

AS-19176

BC677673

BCP21333

BDBM50228731

Benzeneacetamide, 2-amino-3-benzoyl-

BRD-K04112579-001-02-1

CAS-78281-72-8

CHEBI:75922

CHEMBL1021

CN0055

CS-0899

D05143

DB06802

DSSTox_CID_28564

DSSTox_GSID_48638

DSSTox_RID_82836

DTXSID0048638

EX-A1350

FT-0080494

FT-0603701

GTPL7564

HMS3654P07

HY-17357

I14-1056

J-507774

KB-58126

KS-000011BS

LS-186492

LS-187354

MFCD08067732

MLS003915618

MLS004774140

MLS006010644

MolPort-003-987-236

N0932

NCGC00185741-01

NCGC00185741-02

Nepafena

Nepafenac

Nepafenac (JAN/USAN/INN)

Nepafenac [USAN:INN:BAN:JAN]

Nepafenac [USAN]

Nepafenac, >=98% (HPLC)

nepafenaco

nepafenacum

Nevanac

Nevanac (TN)

PubChem17348

QEFAQIPZVLVERP-UHFFFAOYSA-N

RL05033

s1255

SC-20092

SCHEMBL93835

SMR002529588

SR-01000931908

SR-01000931908-2

STL451069

SW219197-1

TL8005351

Tox21_112985

Tox21_112985_1

UNII-0J9L7J6V8C

W-5364

X5012

ZINC5162311

US Patents and Regulatory Information for ILEVRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Novartis Pharms Corp	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Novartis Pharms Corp	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y

Expired US Patents for ILEVRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Novartis Pharms Corp	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012

Paragraph IV (Patent) Challenges for ILEVRO

Drugname	Dosage	Strength	RLD	Date
	Ophthalmic Suspension	0.3%

International Patents for ILEVRO

Country	Patent Number	Estimated Expiration
Slovenia	2116227
Poland	2965749
Hong Kong	1217091
Canada	2839928
Brazil	112012013503
South Korea	101809484

Supplementary Protection Certificates for ILEVRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0999825	CA 2013 00055	Denmark		PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825	92301	Luxembourg		PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503