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Last Updated: November 15, 2019

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ONDANSETRON HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for ondansetron hydrochloride and what is the scope of freedom to operate?

Ondansetron hydrochloride is the generic ingredient in six branded drugs marketed by 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), Teva, West-ward Pharms Int, Wockhardt, Emcure Pharms Ltd, Sun Pharm Inds Ltd, Taro Pharms Ireland, Novartis, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for ondansetron hydrochloride. Seventy-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE

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

SponsorPhase
Tanta UniversityPhase 4
Assiut UniversityN/A
Mohamed Elsayed AfandyPhase 4

See all ONDANSETRON HYDROCHLORIDE clinical trials

Recent Litigation for ONDANSETRON HYDROCHLORIDE

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 HYDROCHLORIDE litigation

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION

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 HYDROCHLORIDE
Synonyms for ONDANSETRON HYDROCHLORIDE
103639-04-9
110204-46-1
110707-92-1
4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-, monohydrochloride
9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride
9-METHYL-3-((2-METHYL-1H-IMIDAZOL-1-YL)METHYL)-2,3-DIHYDRO-1H-CARBAZOL-4(9H)-ONE HYDROCHLORIDE
9-Methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-4H-carbazol-4-one monohydrochloride
9-methyl-3-[(2-methyl-1-imidazolyl)methyl]-2,3-dihydro-1H-carbazol-4-one hydrochloride
9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4h-carbazol-4-onhydrochlorid
9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1H-carbazol-4-one hydrochloride
9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one hydrochloride
99614-01-4
99614-02-5 (Parent)
A800774
AB0016622
AB07046
AB2000081
AC-12464
AC1L2A5S
AC1Q3ERO
AKOS015889292
API0003688
BC204680
BG0279
C18H19N3O.HCl
CCG-100852
CCG-221058
CHEMBL1201111
CPD000469179
CS-1715
CTK8F0270
Emeset
Emetron
GR 38032
GR-38032F
GS-3597
H39O049
HMS1571C18
HY-B0002
I01-1935
I06-0131
I06-131
LS-51879
MKBLHFILKIKSQM-UHFFFAOYSA-N
MLS001304076
MLS001401397
MLS002222312
MolPort-003-983-448
NC00102
NSC 665799
NSC-665799
NSC665799
O0407
O739
Ondansetron (Hydrochloride)
ONDANSETRON HCl
Ondansetron hydrochloride (Zofran)
Ondansetron hydrochloride and dextrose in plastic container
Ondansetron hydrochloride and sodium chloride in plastic container
Ondansetron hydrochloride preservative free
Ondemet
Ondemet;Emeset;Emetron;Zofran
PubChem17490
Q-201515
REGID_for_CID_68647
RT-014862
s1390
SAM001246631
SCHEMBL41455
SMR000469179
SN 307
SR-01000763250
SR-01000763250-5
SW100810-5
TL8000158
VU0424014-2
Zofran
Zofran and dextrose in plastic container
ZOFRAN PRESERVATIVE FREE
Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN SOLUTION;ORAL ondansetron hydrochloride 020605 2004-12-20
ZOFRAN TABLET;ORAL ondansetron hydrochloride 020103
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER INJECTABLE;INJECTION ondansetron hydrochloride 020403
ZOFRAN INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN PRESERVATIVE FREE INJECTABLE;INJECTION ondansetron hydrochloride 020007

US Patents and Regulatory Information for ONDANSETRON HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 076978-001 Feb 26, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077535-003 Jun 25, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Qilu Pharm Co Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 203711-001 Sep 8, 2014 AP 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

Expired US Patents for ONDANSETRON HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Boehringer Ingelheim
McKinsey
Dow
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Colorcon

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