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Generated: September 17, 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 ondansetron hydrochloride patent protection?

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 Pharms Corp, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pd Partners, 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. Eighty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

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
Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 2MG BASE/MLINJECTABLE;INJECTION
➤ Sign Up➤ Sign UpEQ 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.

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
Wockhardt ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 077577-001 Dec 26, 2006 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Baxter Hlthcare Corp ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 078288-001 Feb 22, 2013 AP RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Natco Pharma Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851-002 Jun 25, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202600-001 Dec 21, 2012 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Luitpold ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 077582-001 Dec 26, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 076978-001 Feb 26, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
>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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Expired US Patents for ondansetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Chinese Patent Office
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