Ondansetron - Generic Drug Details

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What are the generic drug 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 Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Am Regent, 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 Speclts, Sun Pharm Inds (in), Wockhardt, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, 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-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	615
Patent Applications:	7,423
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
Yongtao Sun	Phase 4
King Saud Medical City	Phase 3
Ain Shams University	N/A

See all ondansetron clinical trials

Generic filers with tentative approvals for ONDANSETRON

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	8MG	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
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecules	ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	077406-004	Dec 26, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro Pharms Ireland	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	078014-001	Mar 21, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Farmaceutica	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	076781-001	Dec 26, 2006	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076252-003	Jun 25, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077306-002	Jun 25, 2007	AB	RX	No	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 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	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	2076251	FORMES PHARMACEUTIQUES À BASE DE FILM NON MUCO-ADHÉSIF (NON-MUCOADHESIVE FILM DOSAGE FORMS)	⤷ Sign Up
Denmark	2248519		⤷ Sign Up
China	101626756	Non-mucoadhesive film dosage forms	⤷ Sign Up
Germany	202007019476		⤷ Sign Up
South Korea	101448050		⤷ Sign Up
New Zealand	575900	NON-MUCOADHESIVE FILM DOSAGE FORMS	⤷ Sign Up
>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.