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-six 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 26^th, 2006.

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Summary for ZOFRAN

US Patents:	0
Applicants:	2
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	161
Patent Applications:	4,048
Drug Prices:	Drug price information for ZOFRAN
Drug Sales Revenues:	Drug sales revenues for ZOFRAN
What excipients (inactive ingredients) are in ZOFRAN?	ZOFRAN excipients list
DailyMed Link:	ZOFRAN at DailyMed

Drug patent expirations by year for ZOFRAN

Recent Clinical Trials for ZOFRAN

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

Sponsor	Phase
Tanta University	Phase 3
Tanta University	Phase 2/Phase 3
Emory University	Phase 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992		DISCN	Yes	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

Expired US Patents for ZOFRAN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	2200046	PHARMACEUTICAL COMPOSITIONS FOR TREATING GASTRIC DISORDERS	⤷ Sign Up
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.)	⤷ Sign Up
South Korea	920003064		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ZOFRAN

Recent Clinical Trials for ZOFRAN

Paragraph IV (Patent) Challenges for ZOFRAN

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