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Last Updated: August 9, 2020

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Granisetron - Generic Drug Details

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What are the generic drug 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 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-one NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has fifty-seven 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
Fudan UniversityPhase 2
Assiut UniversityEarly Phase 1
University of Alabama at BirminghamPhase 2

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Pharmacology for granisetron
Medical Subject Heading (MeSH) Categories for granisetron
Paragraph IV (Patent) Challenges for GRANISETRON
Tradename Dosage Ingredient NDA Submissiondate
SANCUSO FILM, EXTENDED RELEASE;TRANSDERMAL granisetron 022198 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
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203453-001 Jan 31, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Dr Reddys GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077297-001 Jun 30, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091136-002 Apr 9, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-004 Mar 11, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091137-002 Apr 9, 2010 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

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Serving leading biopharmaceutical companies globally:

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