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Last Updated: May 2, 2024

ONDANSETRON - Generic Drug Details

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What are the generic sources for ondansetron and what is the scope of freedom to operate?

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Steriscience, Sun Pharm Inds (in), Wockhardt, Am Regent, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, and Natco Pharma Ltd, and is included in eighty-five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ondansetron has eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for ONDANSETRON

International Patents:	18
US Patents:	2
Tradenames:	9
Applicants:	43
NDAs:	85
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	610
Patent Applications:	7,384
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ONDANSETRON
Drug Sales Revenues:	Drug sales revenues for ONDANSETRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONDANSETRON
What excipients (inactive ingredients) are in ONDANSETRON?	ONDANSETRON excipients list
DailyMed Link:	ONDANSETRON at DailyMed

See drug prices for ONDANSETRON

Drug Sales Revenue Trends for ONDANSETRON

See drug sales revenues for ONDANSETRON

Recent Clinical Trials for ONDANSETRON

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Adwia Pharma, Egypt	Phase 3
Purdue University	Phase 4

See all ONDANSETRON clinical trials

Generic filers with tentative approvals for ONDANSETRON

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Try a Trial	⤷ Try a Trial	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Try a Trial	⤷ Try a Trial	4MG	TABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ONDANSETRON

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for ONDANSETRON

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ONDANSETRON

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ONDANSETRON

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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
Apotex	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077306-002	Jun 25, 2007	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	078288-001	Feb 22, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077851-001	Jun 25, 2007	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	079032-001	Nov 18, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-002	Jul 2, 2010		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Gland Pharma Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	090648-001	Jun 15, 2012	AP	RX	No	Yes	⤷ 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 ONDANSETRON

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ONDANSETRON

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0719840	FORMAS DE DOSAGEM DE PELÍCULAS NÃO-MUCOADESIVA	⤷ Try a Trial
Mexico	2009003372	FORMAS DE DOSIFICACION DE PELICULA NO MUCOADHESIVA. (NON-MUCOADHESIVE FILM DOSAGE FORMS.)	⤷ Try a Trial
Denmark	2248519		⤷ Try a Trial
European Patent Office	2248519	Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms)	⤷ Try a Trial
Spain	2652592		⤷ Try a Trial
Hungary	E038022		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.