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Last Updated: February 16, 2020

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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 freedom to operate?

Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Actavis Mid Atlantic, Amneal Pharms, Cipla, Glenmark Pharms Ltd, Hi Tech, Mylan, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Novartis, Mylan Labs Ltd, Javelin Pharms Inc, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Zydus Pharms, Hznp, Nuvo Pharms Inc, Actavis Elizabeth, Allied, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in fifty-eight 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. Seventy-five suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for diclofenac sodium

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Drug Sales Revenue Trends for diclofenac sodium

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Recent Clinical Trials for diclofenac sodium

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

SponsorPhase
Cukurova UniversityPhase 4
Taha U├žarPhase 4
Winston Parris, MDPhase 1

See all diclofenac sodium clinical trials

Recent Litigation for diclofenac sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
HORIZON PHARMA IRELAND LIMITED v. LUPIN LTD.2016-08-18
Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited2016-04-04
HORIZON PHARMA IRELAND LIMITED v. ACTAVIS LABORATORIES UT, INC.2015-10-27

See all diclofenac sodium litigation

Generic filers with tentative approvals for DICLOFENAC SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5% W/WSOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
B1457
Ba 47210
Batafil
BBC/461
BC201631
BCP02915
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
D-181
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 sodium, 98%
Diclofenac Sodium,(S)
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
HMS3713H10
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
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-(2,6-dichlorophenylamino)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
sodium;2-[2-(2,6-dichloroanilino)phenyl]acetate.
Solaraze
Solaraze (TN)
SPECTRUM1500237
ST024738
STK400073
SW196404-3
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
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM
Tradename Dosage Ingredient NDA Submissiondate
DYLOJECT SOLUTION;INTRAVENOUS diclofenac sodium 022396 2015-12-15
PENNSAID SOLUTION;TOPICAL diclofenac sodium 204623 2014-06-03
PENNSAID SOLUTION;TOPICAL diclofenac sodium 020947 2012-07-11
SOLARAZE GEL;TOPICAL diclofenac sodium 021005 2009-12-16

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
Casi Pharms Inc DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074394-001 Nov 30, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 077600-001 Nov 13, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Unique Pharm Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 077863-003 Jun 8, 2007 AB RX No Yes   Start Trial   Start Trial   Start Trial
Hznp PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
Javelin Pharms Inc DYLOJECT diclofenac sodium SOLUTION;INTRAVENOUS 022396-001 Dec 23, 2014   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium TABLET, DELAYED RELEASE;ORAL 019201-003 Jul 28, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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