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Last Updated: October 25, 2021

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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, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hikma Pharms, Mylan Asi, Mylan Labs Ltd, Puniska, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Roche, Intra Sana Labs, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, 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-eight 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

SponsorPhase
PPDPhase 1
Kyowa Kirin, Inc.Phase 1
Fudan UniversityPhase 3

See all granisetron clinical trials

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
Hikma Farmaceutica GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078629-002 Dec 23, 2009 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Orchid Hlthcare GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078678-001 Feb 13, 2008 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Baxter Hlthcare Corp GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078197-001 Dec 31, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Puniska GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078258-001 Jun 30, 2008 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 ⤷  Try it Free ⤷  Try it Free
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Mallinckrodt
McKinsey
Johnson and Johnson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.