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Last Updated: December 6, 2019

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Ondansetron - Generic Drug Details

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What are the generic drug sources for ondansetron and what is the scope of patent protection?

Ondansetron is the generic ingredient in nine branded drugs marketed by Midatech Pharma Us, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Novartis, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), West-ward Pharms Int, Wockhardt, Emcure Pharms Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Ipca Labs Ltd, and Natco Pharma Ltd, and is included in eighty-four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ondansetron has eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-one suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for ondansetron

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Drug Sales Revenue Trends for ondansetron

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Recent Clinical Trials for ondansetron

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

SponsorPhase
Adial PharmaceuticalsPhase 3
University of Illinois at ChicagoPhase 4
Assiut UniversityN/A

See all ondansetron clinical trials

Recent Litigation for ondansetron

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 ondansetron litigation

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start Trial8MGTABLET, ORALLY DISINTEGRATING;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 ondansetron
Medical Subject Heading (MeSH) Categories for ondansetron
Synonyms for ondansetron
(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 (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
ZOFRAN IN PLASTIC CONTAINER
Zofran ODT
Zofran ODT (TN)
Zophren
Zudan
Zuplenz
Paragraph IV (Patent) Challenges for ONDANSETRON
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN ODT TABLET, ORALLY DISINTEGRATING;ORAL ondansetron 020781

US Patents and Regulatory Information for ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078050-001 Aug 13, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Nesher Pharms ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077717-001 Jun 25, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Emcure Pharms Ltd ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 078945-001 Jan 3, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 078539-003 Jul 31, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077306-002 Jun 25, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell Molecules ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077303-004 Jun 25, 2007 DISCN 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

Expired US Patents for ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.