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Express Scripts
Boehringer Ingelheim

Last Updated: August 6, 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 patent protection?

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

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

Fudan UniversityPhase 2
Assiut UniversityEarly Phase 1
Heron TherapeuticsPhase 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

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
Wockhardt Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078566-001 Feb 29, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 079078-001 Sep 14, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride TABLET;ORAL 020305-001 Mar 16, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Taro GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 090817-001 May 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078863-001 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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