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Last Updated: March 29, 2024

GRANISETRON HYDROCHLORIDE Drug Patent Profile


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Which patents cover Granisetron Hydrochloride, and what generic alternatives are available?

Granisetron Hydrochloride is a drug marketed by 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, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms. and is included in forty-six NDAs.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Granisetron Hydrochloride

A generic version of GRANISETRON HYDROCHLORIDE was approved as granisetron hydrochloride by AMNEAL on December 31st, 2007.

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Drug patent expirations by year for GRANISETRON HYDROCHLORIDE
Recent Clinical Trials for GRANISETRON HYDROCHLORIDE

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

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Pharmacology for GRANISETRON HYDROCHLORIDE
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yung Shin Pharm GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 202647-001 Mar 6, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078808-001 Apr 29, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078260-001 Dec 31, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078725-001 Jan 30, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 077842-001 Dec 31, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 078863-002 Jun 30, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203453-001 Jan 31, 2017 DISCN 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

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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.