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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
Fish and Richardson
McKesson
Federal Trade Commission
Boehringer Ingelheim
Cerilliant
Cantor Fitzgerald
US Army

Generated: August 20, 2018

DrugPatentWatch Database Preview

Nepafenac - Generic Drug Details

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What are the generic sources for nepafenac and what is the scope of nepafenac patent protection?

Nepafenac is the generic ingredient in two branded drugs marketed by Novartis Pharms Corp and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nepafenac has one hundred and thirty-nine patent family members in twenty-six countries.

There are eight drug master file entries for nepafenac. One supplier is listed for this compound.

Pharmacology for nepafenac
Synonyms for nepafenac
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
Benzeneacetamide, 2-amino-3-benzoyl-
CAS-78281-72-8
CHEBI:75922
CHEMBL1021
CN0055
CS-0899
D02IHW
D05143
DB06802
DR000704
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 (JAN/USAN/INN)
Nepafenac [USAN]
Nepafenac, >=98% (HPLC)
nepafenaco
nepafenacum
Nevanac
Nevanac (TN)
OR341072
PubChem17348
QEFAQIPZVLVERP-UHFFFAOYSA-N
RL05033
s1255
SBB067082
SC-20092
SCHEMBL93835
SMR002529588
SR-01000931908
SR-01000931908-2
STL451069
TL8005351
Tox21_112985
Tox21_112985_1
UNII-0J9L7J6V8C
W-5364
X5012
ZINC5162311

US Patents and Regulatory Information for nepafenac

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 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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Expired US Patents for nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for nepafenac

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
7,709,012 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Sign Up
8,313,754 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Sign Up
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
6,583,124 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for nepafenac

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
301 Luxembourg ➤ Sign Up PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0716600/01 Switzerland ➤ Sign Up PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
2013000085 Germany ➤ Sign Up PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
2013 00055 Denmark ➤ Sign Up 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
00622 Netherlands ➤ Sign Up PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Accenture
Mallinckrodt
Merck
AstraZeneca
Moodys
Colorcon
Chinese Patent Office
Medtronic

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.