Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 16, 2019

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Diclofenac - Generic Drug Details

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What are the generic sources for diclofenac and what is the scope of freedom to operate?

Diclofenac is the generic ingredient in fifteen branded drugs marketed by Zyla, Inst Biochem, Ibsa Inst Bio, Bionpharma Inc, Assertio, Par Form, Novartis, Amici, Casi Pharms Inc, Mylan, Sandoz, Sun Pharm Industries, Teva, Watson Labs Teva, Actavis Mid Atlantic, Amneal Pharms, Cipla, Glenmark Pharms Ltd, Hi Tech, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, 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, Mylan Pharms Inc, Pliva, Roxane, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, and Exela Holdings, and is included in seventy-three NDAs. There are forty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has forty-three patent family members in twenty-three countries.

There are forty-seven drug master file entries for diclofenac. Two suppliers are listed for this compound. There are seven tentative approvals for this compound.

Drug Prices for diclofenac

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Drug Sales Revenue Trends for diclofenac

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Recent Clinical Trials for diclofenac

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

SponsorPhase
National Institutes of Health (NIH)Phase 2
University of Alabama at BirminghamPhase 2
Avanos MedicalPhase 4

See all diclofenac clinical trials

Recent Litigation for diclofenac

Identify potential future generic entrants

District Court Litigation
Case NameDate
iCeutica Pty Ltd. v. Apotex, Inc.2017-10-31
iCeutica Pty Ltd. v. Lupin Limited

See all diclofenac litigation

PTAB Litigation
PetitionerDate
Lupin Pharmaceuticals, Inc.2015-12-28

See all diclofenac litigation

Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5% W/WSOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL
  Start Trial  Start Trial35MGCAPSULE;ORAL

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

Pharmacology for diclofenac
Medical Subject Heading (MeSH) Categories for diclofenac
Synonyms for diclofenac
[2-(2,6-dichloro-phenylamino)-phenyl]-acetic acid
[2-(2,6-Dichloroanilino)phenyl]-acetic acid; 2-[2-(2,6-Dichlorophenyl)aminophenyl]ethanoic acid
[2-(2,6-Dichloroanilino)phenyl]acetic acid
[2-(2,6-Dichloroanilino)phenyl]acetic acid #
[o-(2,6-dichloro-anilino)-phenyl]-acetic acid
{2-[(2,6-dichlorophenyl)amino]phenyl}acetic acid
056D694
144O8QL0L1
15307-81-0 (mono-potassium salt)
15307-86-5
2-((2,6-Dichlorophenyl)amino)benzeneacetic acid
2-(2-((2,6-Dichlorophenyl)amino)phenyl)acetic acid
2-(2-(2,6-dichlorophenylamino)phenyl)acetic acid
2-(2,6-Dichloroanilino)phenylacetic Acid
2-[(2,6-dichlorophenyl)-amino]-benzeneacetic acid
2-[(2,6-dichlorophenyl)-amino]-phenyl-acetic acid
2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid
2-[(2,6-dichlorophenyl)amino]-phenyl-acetic acid
2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid
2-[(2,6-dichlorophenyl)amino]phenylacetic acid
2-[2-(2,6-dichloroanilino)phenyl]acetic acid
2-[2-(2,6-dichloroanilino)phenyl]acetic acid.
2-[2-(2,6-dichlorophenyl)aminophenyl]ethanoic acid
2-[2-(2,6-dichlorophenylamino)-phenyl]-acetic acid
2-[2-(2,6-dichlorophenylamino)phenyl]-acetic acid
2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetic acid
2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)
2-[2,6-DICHLOROPHENYL)AMINO]BENZENEACETIC ACID
2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetic acid
2b17
AB01275502_02
AB01275502-01
AB1009343
AC-27673
AC1L1F0T
ACETIC ACID, (o-(2,6-DICHLOROANILINO)PHENYL)-
ACMC-209d8r
AJ-07992
AK-75694
AKOS001579542
ANW-21433
Apo-Diclo
Assaren
BC208012
BCP09087
BCP13860
BDBM13066
Benfofen
Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-
Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)- (9CI)
Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-
BIDD:GT0380
BPBio1_000516
BRD-K08252256-236-05-6
BRD-K08252256-236-17-1
BRN 2146636
BSPBio_000468
BSPBio_002169
C01690
Cataflam
CGP-45840B
CHEBI:47381
CHEMBL139
cMAP_000014
CS-2862
CTK8B0851
D07816
D30801
D3748
DB00586
DCOPUUMXTXDBNB-UHFFFAOYSA-N
dichlofenac
Dichlofenal
Diclo-Phlogont
Diclo-Puren
Diclobenin
Diclofenac (USAN/INN)
Diclofenac [INN:BAN]
Diclofenac [USAN:INN:BAN]
Diclofenac acid
Diclofenac resinate
Diclofenaco
Diclofenaco [INN-Spanish]
Diclofenacum
Diclofenacum [INN-Latin]
Diclofenamic acid
Diclonate P
Diclophenac
Diclord
Dicloreum
Dicrofenac
DIF
DivK1c_000272
DivK1c_000402
Dolobasan
DTXSID6022923
Duravolten
Dyloject
EBD50236
EC 239-348-5
Ecofenac
Effekton
EINECS 239-348-5
Epitope ID:116873
F0722-0745
FT-0624731
GP-45,840
GP-45840
GTPL2714
HMS2090C10
HMS501E04
HSDB 7234
HY-15036
I14-7739
IDI1_000272
IDI1_000402
ISV-205
KBio1_000272
KBio1_000402
KBio2_001410
KBio2_002306
KBio2_003978
KBio2_004874
KBio2_006546
KBio2_007442
KBio3_001389
KBio3_002786
KBioGR_001051
KBioGR_002306
KBioSS_001410
KBioSS_002308
KS-000001OB
KS-1258
Lopac0_000441
LS-11575
M-7482
MCULE-1824024270
MLS006011795
MolPort-000-003-072
NCGC00021125-01
NCGC00021125-02
NINDS_000272
NINDS_000402
Novapirina
Novo-Difenac
Novo-Difenac SR
Nu-Diclo
o-(2,6-dichloroanilino)phenylacetic acid
Olfen
Oprea1_011155
Pennsaid
Prestwick0_000594
Prestwick1_000594
Prestwick2_000594
Prestwick3_000594
Primofenac
ProSorb-D
Rhumalgan
SBI-0051341.P003
SC-16284
SCHEMBL2799
SMR001550371
Solaraze
Solaraze (TN)
Solaraze T
SPBio_001081
SPBio_002687
Spectrum_000930
Spectrum2_000991
Spectrum3_000385
Spectrum4_000506
Spectrum5_000867
SR-01000003041-3
SR-38
ST51039044
STK984493
TC-110178
UNII-144O8QL0L1
UNM000001216103
Voldal
Voltaren
Voltaren Ophtha
Voltaren Rapide
Voltaren SR
Voltaren-XR
Voltarol
Xenid
Z57664869
ZINC1281
Zorovolex
Zorvolex
Zorvolex (TN)
Paragraph IV (Patent) Challenges for DICLOFENAC
Tradename Dosage Ingredient NDA Submissiondate
ZORVOLEX CAPSULE;ORAL diclofenac 204592 2014-06-06

US Patents and Regulatory Information for diclofenac

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077-001 Mar 18, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Perrigo Uk Finco DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 211253-001 May 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Roxane DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074391-001 Jun 29, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo Uk Finco DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 210893-001 Jul 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Dow
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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.