Granisetron hydrochloride - Generic Drug Details

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

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Norvium Bioscience, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Roche, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in fifty NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for granisetron hydrochloride. Seven suppliers are listed for this compound.

Summary for granisetron hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	29
NDAs:	50
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	125
Patent Applications:	3,186
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for granisetron hydrochloride
What excipients (inactive ingredients) are in granisetron hydrochloride?	granisetron hydrochloride excipients list
DailyMed Link:	granisetron hydrochloride at DailyMed

Recent Clinical Trials for granisetron hydrochloride

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Guangxi Medical University	Phase 3
Heron Therapeutics	Phase 4

See all granisetron hydrochloride clinical trials

Pharmacology for granisetron hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for granisetron hydrochloride

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

Paragraph IV (Patent) Challenges for GRANISETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYTRIL	Injection	granisetron hydrochloride	0.1 mg/mL, 1 mL single dose vial	020239	1	2007-03-08
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 4 mL multi-dose vials	020239	1	2004-07-19
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 1 mL vials	020239	1	2004-06-01

US Patents and Regulatory Information for granisetron 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
Dr Reddys	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078392-001	Dec 31, 2007	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yung Shin Pharm	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	202648-002	Jun 29, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yung Shin Pharm	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	202648-001	Jun 29, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078725-001	Jan 30, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078880-001	Jun 30, 2008	AP	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 granisetron hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-001	Mar 16, 1995	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-004	Mar 11, 1994	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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