ONDANSETRON HYDROCHLORIDE - Generic Drug Details

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

Ondansetron hydrochloride is the generic ingredient in six branded drugs marketed by 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, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, Sun Pharm Inds Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for ondansetron hydrochloride. Sixty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ONDANSETRON HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	38
NDAs:	72
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	615
Patent Applications:	2,135
What excipients (inactive ingredients) are in ONDANSETRON HYDROCHLORIDE?	ONDANSETRON HYDROCHLORIDE excipients list
DailyMed Link:	ONDANSETRON HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 2MG BASE/ML	INJECTABLE;INJECTION
		EQ 2MG BASE/ML	INJECTABLE;INJECTION

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 HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ONDANSETRON HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE

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 ONDANSETRON HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	202253-001	Jul 19, 2013	AP	RX	No	No
Dr Reddys Labs Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076183-003	Dec 26, 2006	AB	RX	No	No
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997		DISCN	Yes	No
Ipca Labs Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	203761-002	Jan 23, 2014	AB	RX	No	No
Wockhardt	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	077716-001	Dec 26, 2006	AP	RX	No	No
Steriscience Speclts	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	078257-001	Apr 23, 2008		DISCN	No	No
Aurobindo Pharma	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	078539-003	Jul 31, 2007		DISCN	No	No

Expired US Patents for ONDANSETRON HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999