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Generated: December 12, 2018

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Diclofenac sodium - Generic Drug Details

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

Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Actavis Mid Atlantic, Amneal Pharms, Cipla, Glenmark Pharms Ltd, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Anda Repository, Apotex Inc, Bausch And Lomb, Falcon Pharms, Sandoz Inc, Novartis, Javelin Pharms Inc, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Hznp, Nuvo Pharms Inc, Actavis Elizabeth, Allied, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in fifty-four NDAs. There are twenty-one patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has forty-two patent family members in fifteen countries.

There are forty-seven drug master file entries for diclofenac sodium. Ninety-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Synonyms for diclofenac sodium
(o-(2,6-Dichloroanilino)phenyl)acetic acid monosodium salt
(o-(2,6-Dichloroanilino)phenyl)acetic acid sodium salt
1147187-62-9
15307-79-6
2-((2,6-Dichlorophenyl)amino)benzeneacetic acid monosodium salt
2-(2,6-DICHLOROANILINO)PHENYLACETIC ACID SODIUM SA
2-(2,6-Dichloroanilino)phenylacetic Acid Sodium Salt
2-[(2,6-Dichlorophenyl)amino]-benzeneacetic acid monosodium salt
2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium
2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt
2-[(2,6-Dichlorophenyl)amino]benzeneacetic Acid, Na
A809387
AB0013319
AB1009344
Abitren
AC-1487
AC1NMYU1
AC1Q1V6Y
Acetic acid, o-(2,6-dichloroanilino)phenyl-, monosodium salt
AKOS000310014
AKOS005267222
AKOS024278942
Allvoran
AN-14916
Anthraxiton
API0002325
ARONIS24305
Assaren
Ba 47210
Batafil
BBC/461
BC201631
BCP0726000303
BCP9000605
Benfofen
Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, monosodium salt
Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt
Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt [CAS]
Berifen
BG0165
BIM-0051341.0001
Blesin
C14H10Cl2NNaO2
CAS-15307-79-6
CCG-100765
CCG-39754
CCRIS 1909
CHEBI:4509
CHEMBL1034
CPD000058567
CPD000449318
CS-2355
D 6899
D00904
D2508
Delimon
Delphimix
DIC075V
Dichronic
Diclofenac (Sodium)
Diclofenac sod
Diclofenac sodium (JP17/USP)
Diclofenac sodium [USAN:JAN]
Diclofenac sodium [USAN:USP:JAN]
Diclofenac Sodium 1.0 mg/ml in Methanol (as free acid)
Diclofenac sodium injection
Diclofenac sodium salt
Diclofenac sodium topical gel
Diclofenac-D4 (Major)
Diclophenac sodium
DSSTox_CID_17208
DSSTox_GSID_37208
DSSTox_RID_79308
DTXSID3037208
Dyloject
EC 239-346-4
Ecofenac
EINECS 239-346-4
EU-0100441
Feloran
FT-0624732
GP 45840
GP-45840
GP9539
H867
HMS1569H10
HMS1920E16
HMS2051M05
HMS2091M06
HMS2096H10
HMS2235O06
HMS2236D03
HMS3261I04
HMS3369K11
HMS3371J05
HMS3393M05
HMS3650B13
HMS3655A22
HMS500N14
HY-15037
I06-0162
I06-162
IN1491
K-4848
KPHWPUGNDIVLNH-UHFFFAOYSA-M
Kriplex
KS-00000KCZ
KS-000048IF
KS-5038
KSC-322-017
KUC112363N
Lopac-D-6899
LP00441
LS-11576
MCULE-3279769301
MFCD00082251
MLS000028386
MLS000758255
MLS001148587
MLS001423970
MLS002222163
MLS003882590
MolPort-000-699-119
NC00015
NCGC00015361-01
NCGC00015361-02
NCGC00015361-03
NCGC00015361-04
NCGC00017082-01
NCGC00017082-02
NCGC00017082-03
NCGC00021125-03
NCGC00093858-01
NCGC00093858-02
NCGC00094648-01
NCGC00094648-02
NCGC00253928-01
NCGC00261126-01
Neriodin
Olfen
Opera_ID_564
OR067148
OR114393
OR224831
Orthophen
Ortofen
potassium diclofenac(1-)
Prophenatin
Q-200965
QTG126297Q
REGID_for_CID_5018304
RL01959
s1903
SAM001247057
SBB032269
SC-25991
SCHEMBL24009
SMR000058567
SMR000449318
Sodium (2-((2,6-dichlorophenyl)amino)phenyl)acetate
Sodium (o-((2,6-dichlorophenyl)amino)phenyl)acetate
Sodium (o-(2,6-dichloroanilino)phenyl) acetate
Sodium (o-(2,6-dichloroanilino)phenyl)acetate
sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate
sodium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate
sodium 2-(2,6-dichloroanilino)-phenylacetate
Sodium 2-(2,6-Dichloroanilino)phenylacetate
sodium 2-[(2,6-dichlorophenyl)-amino]-phenyl-acetate
sodium 2-[(2,6-dichlorophenyl)-amino]-phenylacetate
sodium 2-[(2,6-dichlorophenyl)-amino]phenylacetate
sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate
sodium 2-[2-(2,6-dichloroanilino)phenyl]acetate
Sodium 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate
sodium 2-[2-[[2,6-bis(chloranyl)phenyl]amino]phenyl]ethanoate
sodium 2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetate
SODIUM DICHLOFENAC
Sodium diclofenac
sodium diclofenac(1-)
sodium;2-[2-(2,6-dichloroanilino)phenyl]acetate
Solaraze
Solaraze (TN)
SPECTRUM1500237
ST024738
STK400073
STOCK1S-60350
TDS 943
Tox21_110770
Tox21_110770_1
Tox21_300265
Tox21_500441
Tsudohmin
UNII-QTG126297Q
Urigon
Valetan
Voltaren
Voltaren (TN)
Voltaren Gel
Voltaren ophthalmic
Voltaren-XR
Voltarene
Vonafec
Vurdon
ZX-AS004665
Tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL
➤ Sign Up➤ Sign Up2%SOLUTION;TOPICAL

US Patents and Regulatory Information for diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-001 May 9, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 206298-001 Apr 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novel Labs Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 205878-001 Dec 9, 2015 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hznp PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Unique Pharm Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066-001 Dec 1, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Elizabeth DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074514-001 Mar 26, 1996 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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 diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-001 Jul 28, 1988 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-002 Jul 28, 1988 ➤ Sign Up ➤ Sign Up
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 ➤ Sign Up ➤ Sign Up
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Queensland Health
Harvard Business School
Fuji
Argus Health
QuintilesIMS
AstraZeneca
Daiichi Sankyo

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.