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Last Updated: October 23, 2020

DrugPatentWatch Database Preview

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 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-two 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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Universiti Sains MalaysiaPhase 2
Fudan UniversityPhase 2
Assiut UniversityEarly Phase 1

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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

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
Pediatrx GRANISOL granisetron hydrochloride SOLUTION;ORAL 078334-001 Feb 28, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 078096-001 Jun 30, 2008 AP RX No 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 Y   Start Trial
Bionpharma Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078880-001 Jun 30, 2008 AP RX 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
>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:

Boehringer Ingelheim
Johnson and Johnson

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