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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

ZOFRAN ODT Drug Profile

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

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

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

US ANDA Litigation and Generic Entry Outlook for Zofran Odt

A generic version of ZOFRAN ODT was approved as ondansetron by MYLAN on June 25th, 2007.

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Drug patent expirations by year for ZOFRAN ODT
Drug Prices for ZOFRAN ODT

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Recent Clinical Trials for ZOFRAN ODT

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SponsorPhase
State University of New York at BuffaloPhase 3
Camille Ladanyi MDN/A
The Hospital for Sick ChildrenN/A

See all ZOFRAN ODT clinical trials

Paragraph IV (Patent) Challenges for ZOFRAN ODT
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN ODT TABLET, ORALLY DISINTEGRATING;ORAL ondansetron 020781

US Patents and Regulatory Information for ZOFRAN ODT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 AB RX Yes Yes   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 ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Moodys
Colorcon
Baxter
Medtronic

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