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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

ZORVOLEX Drug Profile

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Which patents cover Zorvolex, and when can generic versions of Zorvolex launch?

Zorvolex is a drug marketed by Zyla and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in twenty-three countries.

The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diclofenac profile page.

Drug patent expirations by year for ZORVOLEX
Drug Prices for ZORVOLEX

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Drug Sales Revenue Trends for ZORVOLEX

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Generic Entry Opportunity Date for ZORVOLEX
Generic Entry Date for ZORVOLEX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZORVOLEX

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

SponsorPhase
Regeneron PharmaceuticalsPhase 2
Teva Pharmaceutical Industries, Ltd.Phase 2
Regeneron PharmaceuticalsPhase 3

See all ZORVOLEX clinical trials

Recent Litigation for ZORVOLEX

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 ZORVOLEX litigation

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

See all ZORVOLEX litigation

Pharmacology for ZORVOLEX
Synonyms for ZORVOLEX
[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
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 (TN)
Paragraph IV (Patent) Challenges for ZORVOLEX
Tradename Dosage Ingredient NDA Submissiondate
ZORVOLEX CAPSULE;ORAL diclofenac 204592 2014-06-06

US Patents and Regulatory Information for ZORVOLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No   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

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