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 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, Sun Pharm Inds (in), Wockhardt, 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-five 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:	35
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	610
Patent Applications:	6,982
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

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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
⤷ Sign Up	⤷ Sign Up	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	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
Sun Pharm Inds (in)	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077050-001	Jun 25, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	078180-001	Mar 26, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-001	Jul 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Apotex Inc	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	077368-001	Dec 26, 2006		DISCN	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	020781-002	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
>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	2248519	Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms)	⤷ Sign Up
China	105168186	Non-mucoadhesive film dosage forms	⤷ Sign Up
South Korea	101448050		⤷ Sign Up
China	101626756	Non-mucoadhesive film dosage forms	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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