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Last Updated: August 11, 2020

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Granisetron hydrochloride - Generic Drug Details

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

Granisetron hydrochloride is the generic ingredient in four branded drugs 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, Roche, Pediatrx, 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 fifty NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for granisetron hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityEarly Phase 1
Heron TherapeuticsPhase 2
University of Alabama at BirminghamPhase 2

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
Dr Reddys GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077297-001 Jun 30, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
Natco Pharma GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078969-001 Jun 22, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078198-002 Jun 30, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078531-001 Apr 30, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078564-001 Jun 30, 2008 AP RX 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

Expired US Patents for granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride SOLUTION;ORAL 021238-001 Jun 27, 2001   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-004 Mar 11, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Merck
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Baxter
Express Scripts

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