Ondansetron hydrochloride - Generic Drug Details

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What are the generic drug 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-seven 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:	67
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
⤷ Sign Up	⤷ Sign Up	EQ 2MG BASE/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	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

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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
Gland Pharma Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	090648-001	Jun 15, 2012	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077535-003	Jun 25, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	077551-001	Jun 27, 2007	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
Hospira	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	077548-001	Dec 26, 2006	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecular	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	091342-001	Jan 27, 2011	AA	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 hydrochloride

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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	SOLUTION;ORAL	020605-001	Jan 24, 1997	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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