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Last Updated: January 21, 2020

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ZOFRAN PRESERVATIVE FREE Drug Profile

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When do Zofran Preservative Free patents expire, and what generic alternatives are available?

Zofran Preservative Free is a drug marketed by Novartis and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Zofran Preservative Free

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A generic version of ZOFRAN PRESERVATIVE FREE was approved as ondansetron hydrochloride by TEVA on January 21st, 2020.

Summary for ZOFRAN PRESERVATIVE FREE
Drug patent expirations by year for ZOFRAN PRESERVATIVE FREE
Synonyms for ZOFRAN PRESERVATIVE FREE
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
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
Paragraph IV (Patent) Challenges for ZOFRAN PRESERVATIVE FREE
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN PRESERVATIVE FREE INJECTABLE;INJECTION ondansetron hydrochloride 020007

US Patents and Regulatory Information for ZOFRAN PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 DISCN 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 PRESERVATIVE FREE

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 PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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