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Last Updated: April 18, 2021

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GRANISETRON HYDROCHLORIDE Drug Profile

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

Granisetron Hydrochloride is a drug marketed by Akorn Inc, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, Puniska, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Yung Shin Pharm, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma, Mylan, Natco Pharma, Orchid Hlthcare, 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. Twelve 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 DR REDDYS 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
Universiti Sains MalaysiaPhase 2
Fudan UniversityPhase 2
Assiut UniversityEarly Phase 1

See all GRANISETRON HYDROCHLORIDE clinical trials

Pharmacology for GRANISETRON HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GRANISETRON HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2007-03-08
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2004-07-19
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 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   Start Trial   Start Trial   Start Trial
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078835-002 Jun 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 077842-001 Dec 31, 2007 AB RX No Yes   Start Trial   Start Trial   Start Trial
Barr GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078221-001 Dec 31, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078725-001 Jan 30, 2008 DISCN No No   Start Trial   Start Trial   Start 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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