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Last Updated: January 30, 2023

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 Kyowa Kirin, Heron Theraps Inc, Akorn, Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma Inc, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Roche, Intra Sana Labs, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, 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.

Drug Prices for granisetron

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Recent Clinical Trials for granisetron

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SponsorPhase
Heron TherapeuticsPhase 4
Baskent UniversityPhase 4
Assiut UniversityN/A

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Pharmacology for granisetron
Medical Subject Heading (MeSH) Categories for granisetron
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bionpharma Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078880-001 Jun 30, 2008 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077186-001 Jun 30, 2008 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078258-002 Jun 30, 2008 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091136-002 Apr 9, 2010 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203454-001 Apr 4, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078565-001 Jun 30, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 See Plans and Pricing See Plans and Pricing
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for granisetron

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

Country Patent Number Title Estimated Expiration
Japan 2017008113 半固体送達賦形剤および薬学的組成物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
Australia 2004210181 Transdermal granisetron See Plans and Pricing
Spain 2529574 See Plans and Pricing
China 102416009 Transdermal granisetron See Plans and Pricing
China 102526043 Transdermal granisetron See Plans and Pricing
Hong Kong 1082199 Transdermal granisetron See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Mallinckrodt
McKinsey
Johnson and Johnson
Moodys

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.