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Last Updated: April 24, 2024

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, Mylan Labs Ltd, 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.

Drug Prices for granisetron

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for granisetron
Generic Entry Dates for granisetron*:
Constraining patent/regulatory exclusivity:
Dosage:
FILM, EXTENDED RELEASE;TRANSDERMAL
Generic Entry Dates for granisetron*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTION, EXTENDED RELEASE;SUBCUTANEOUS

*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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Guangxi Medical UniversityPhase 3
Heron TherapeuticsPhase 4

See all granisetron clinical trials

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
Dr Reddys GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 077165-001 Dec 31, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091137-002 Apr 9, 2010 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077177-001 Dec 31, 2007 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078198-002 Jun 30, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091274-001 Sep 22, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078835-002 Jun 30, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 ⤷  Try a Trial ⤷  Try a Trial
>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 2006516601 ⤷  Try a Trial
Australia 2004210181 Transdermal granisetron ⤷  Try a Trial
Spain 2529574 ⤷  Try a Trial
Iceland 7997 Granisetron lyfjaplástur ⤷  Try a Trial
Hong Kong 1213477 半固體遞送載體和藥物組合物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Taiwan 200616650 Semi-solid delivery vehicle and pharmaceutical compositions ⤷  Try a Trial
>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.