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: December 14, 2019

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ZOFRAN Drug Profile

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Which patents cover Zofran, and what generic alternatives are available?

Zofran is a drug marketed by Novartis and Glaxosmithkline and is included in five NDAs.

The generic ingredient in ZOFRAN is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

US ANDA Litigation and Generic Entry Outlook for Zofran

A generic version of ZOFRAN was launched as ondansetron by BARR on December 14th, 2019.

Drug patent expirations by year for ZOFRAN
Drug Prices for ZOFRAN

See drug prices for ZOFRAN

Drug Sales Revenue Trends for ZOFRAN

See drug sales revenues for ZOFRAN

Recent Clinical Trials for ZOFRAN

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

SponsorPhase
Camille Ladanyi MDN/A
AMAG Pharmaceuticals, Inc.Phase 1
Children's Hospital Research Institute of ManitobaPhase 3

See all ZOFRAN clinical trials

Recent Litigation for ZOFRAN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.2015-12-04
HELSINN HEALTHCARE S.A. v. HOSPIRA, INC.2015-03-23
HELSINN HEALTHCARE S.A. v. DR. REDDY'S LABORATORIES, LTD.2011-07-08

See all ZOFRAN litigation

Pharmacology for ZOFRAN
Synonyms for ZOFRAN
(RS)-1,2,3,9-Tetrahydro-9-methyl-3-(2-methylimidazol-1-ylmethyl)carbazol-4-one
1,2,3,4-Tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-ylmethyl)carbazol-4-one
1,2,3,9-Tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-4H-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H- carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one
1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1yl)methyl]-4H-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazole-1 -yl)methyl]-4H-carbazol-4-one
1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazole-1-yl)methyl]-4H-carbazol-4-one
1,2,3,9,-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one
103639-04-9
103639-04-9 (mono-hydrochloride dihydrate)
108303-49-7
116002-70-1
39O049
4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-
9-Methyl-3- (2-methyl-imidazol-1ylmethyl)-1,2,3,9-tetrahydro-carbazol-4-one
9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one
9-Methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-2,3-dihydro-1H-carbazol-4(9H)-one
9-Methyl-3-(2-methyl-imidazol-1-ylmethyl)-1,2,3,9-tetrahydro-carbazol-4-one
9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one
9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1H-carbazol-4-one
9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one
9-methyl-3-[(2-methylimidazolyl)methyl]-1,2,3,9-tetrahydro-4aH-carbazol-4-one
99614-01-4
99614-01-4 (mono-hydrochloride)
99614-02-5
AB0013753
AB00373674
AB00373674_18
AB00373674_19
AB00373674-15
AB00373674-17
AB2000413
AC-28927
AC1L1IIM
ACN-049703
ACT02589
AKOS000599484
AKOS016340526
AN-6592
Apo-ondansetron
BAS 00717177
BBL010304
BC220610
BCP28911
BCP9001025
BDBM85330
BPBio1_001118
BR-29654
BRD-A19736161-001-01-8
BRD-A19736161-003-03-0
BRN 3622981
BSPBio_001016
C07325
C18H19N3O
CAS_68647
CAS-99614-02-5
CBDivE_008994
CHEBI:7773
CHEMBL46
CPD001307702
CS-2393
CTK8G2184
D00456
DB00904
DSSTox_CID_3393
DSSTox_GSID_23393
DSSTox_RID_77011
DTXSID8023393
FELGMEQIXOGIFQ-UHFFFAOYSA-N
FT-0631004
GR 38032
GR 38032X
GR-38032
GR-38032F
GR-38032F/GR-38032
GR38032
GR38032F
GTPL2290
HMS2090H16
HMS3259H08
HMS3371E18
HSDB 8304
HY-B0002B
I06-0687
I06-1329
I544
KB-308401
KS-00000JSZ
KS-5227
L000456
LS-172305
LS-51878
MCULE-9438746800
MLS006011928
MolPort-001-944-253
NC00706
NCGC00179341-02
NCGC00179341-04
NCGC00179341-07
NCI60_022780
Novo-ondansetron
NSC_68647
Odansetron [common misspelling of ondansetron]
ondansetron
Ondansetron (base and/or unspecified salts)
Ondansetron (JAN/USP/INN)
ondansetron (Zofran)
Ondansetron [USAN:INN:BAN]
Ondansetron [USP:INN:BAN]
ONDANSETRON HCl
Ondansetron Injection
Ondansetron, (+,-)-Isomer
Oprea1_435466
Oprea1_852372
PHL-ondansetron
PMS-ondansetron
Prestwick0_001058
Prestwick1_001058
Prestwick2_001058
Prestwick3_001058
QC-660
Ratio-ondansetron
S-2116
s1996
SAM002589958
Sandoz ondansetron
SBB066158
SC-07554
SCHEMBL4542
SMR001307702
SN-307
SPBio_002938
SR-01000763250
SR-01000763250-4
ST077669
ST2412612
STK370548
TimTec1_001750
TL8006071
Tox21_113048
Tox21_113048_1
VA11441
Z1741971217
ZOFRAN IN PLASTIC CONTAINER
Zofran ODT
Zofran ODT (TN)
Zophren
Zudan
Zuplenz
Paragraph IV (Patent) Challenges for ZOFRAN
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN SOLUTION;ORAL ondansetron hydrochloride 020605 2004-12-20
ZOFRAN INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN PRESERVATIVE FREE INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN TABLET;ORAL ondansetron hydrochloride 020103

US Patents and Regulatory Information for ZOFRAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 AB RX Yes 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

Expired US Patents for ZOFRAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School
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