Granisetron - Generic Drug Details

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

Granisetron is the generic ingredient in six branded drugs marketed by Cumberland, Heron Theraps Inc, 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-two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has fifty-eight patent family members in thirty-two countries.

There are twenty-six drug master file entries for granisetron. Two suppliers are listed for this compound.

Summary for granisetron

International Patents:	58
US Patents:	6
Tradenames:	6
Applicants:	31
NDAs:	52
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	125
Patent Applications:	7,564
Drug Prices:	Drug price trends for granisetron
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for granisetron
What excipients (inactive ingredients) are in granisetron?	granisetron excipients list
DailyMed Link:	granisetron at DailyMed

See drug prices for granisetron

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for granisetron

Generic Entry Date for granisetron^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: FILM, EXTENDED RELEASE;TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for granisetron

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 clinical trials

Pharmacology for granisetron

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

Medical Subject Heading (MeSH) Categories for granisetron

Antiemetics
Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for granisetron

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

Paragraph IV (Patent) Challenges for GRANISETRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCUSO	Transdermal System	granisetron	3.1 mg/24 hrs	022198	1	2015-10-09

US Patents and Regulatory Information for granisetron

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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
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-001	Mar 16, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	203454-002	Apr 4, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intra Sana Labs	GRANISOL	granisetron hydrochloride	SOLUTION;ORAL	078334-001	Feb 28, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare Corp	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078198-002	Jun 30, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078846-001	Feb 27, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	077913-001	Jun 26, 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for granisetron

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296 Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for granisetron

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Country	Patent Number	Title	Estimated Expiration
Ukraine	83362	ПЛАСТЫРЬ, СОДЕРЖАЩИЙ ГРАНИЗЕТРОН, ПРИМЕНЕНИЕ ГРАНИЗЕТРОНА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ;ПЛАСТИР, ЩО МІСТИТЬ ГРАНІЗЕТРОН, ЗАСТОСУВАННЯ ГРАНІЗЕТРОНУ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ (PLASTER, CONTAINING GRANISETRON, USE OF GRANISETRON (VARIANTS) AND METHOD FOR TREATMENT)	⤷ Sign Up
Mexico	PA05008343	GRANISETRON TRANSDERMICO. (TRANSDERMAL GRANISETRON.)	⤷ Sign Up
Spain	2529574		⤷ Sign Up
Poland	379027	Przezskórny granisetron (TRANSDERMAL GRANISETRON)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006037116		⤷ Sign Up
Ecuador	SP055953	GRANISETRON TRANSDERMICO	⤷ 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.