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Last Updated: March 29, 2024

ZOFRAN Drug Patent Profile


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

Zofran is a drug marketed by Sandoz and Glaxosmithkline and is included in five NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Zofran

A generic version of ZOFRAN was approved as ondansetron by CHARTWELL MOLECULES on December 26th, 2006.

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Drug patent expirations by year for ZOFRAN
Drug Prices for ZOFRAN

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Drug Sales Revenue Trends for ZOFRAN

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Recent Clinical Trials for ZOFRAN

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SponsorPhase
Tanta UniversityPhase 3
Tanta UniversityPhase 2/Phase 3
Emory UniversityPhase 2

See all ZOFRAN clinical trials

Paragraph IV (Patent) Challenges for ZOFRAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOFRAN Oral Solution ondansetron hydrochloride 4 mg/5 mL 020605 1 2004-12-20

US Patents and Regulatory Information for ZOFRAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZOFRAN

See the table below for patents covering ZOFRAN around the world.

Country Patent Number Title Estimated Expiration
Germany 19375046 ⤷  Try a Trial
France 2561244 COMPOSES HETEROCYCLIQUES DU TYPE TETRAHYDROCARBAZOLONE, PROCEDE POUR LEUR PREPARATION ET COMPOSITION PHARMACEUTIQUE LES COMPRENANT ⤷  Try a Trial
Czech Republic 9701548 ⤷  Try a Trial
Mexico 9703734 COMPOSICIONES ORALES QUE CONTIENEN ONDANSETRON. (ORAL COMPOSITIONS CONTAINING ONDANSETRON.) ⤷  Try a Trial
Denmark 35785 ⤷  Try a Trial
European Patent Office 0415522 Procédé pour la diminution de la taille des cristaux d'ondansetron hydrochlorure dihydrate. (Process for reducing the crystal size of ondansetron hydrochloride dihydrate.) ⤷  Try a Trial
Canada 1296637 COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES TROUBLES GASTROINTESTINAUX (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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