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Granisetron hydrochloride - Generic Drug Details

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Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Roche, Sandoz Inc, Eurohlth Intl Sarl, Taro, Akorn Inc, Barr, Fresenius Kabi Usa, Mylan, Hikma Farmaceutica, Sandoz, Pediatrx, Sagent Strides, Sagent Agila, Cipla Ltd, Aurobindo Pharma Ltd, Roxane, Apotex Inc, Dr Reddys Labs Ltd, Corepharma, Bionpharma Inc, Teva Pharms Usa, Wockhardt Usa, Natco Pharma, Luitpold, Orchid Hlthcare, Teva Pharms, and Claris, and is included in forty-six NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-five patent family members in nineteen countries.

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

Summary for Generic Name: granisetron hydrochloride

Tradenames:4
Patents:1
Applicants:27
NDAs:46
Drug Master File Entries: see list26
Suppliers / Packaging: see list18
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eurohlth Intl Sarl
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION077186-001Jun 30, 2008RXNo► subscribe► subscribe
Akorn Inc
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION079119-001Sep 10, 2009RXNo► subscribe► subscribe
Aurobindo Pharma Ltd
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION204238-002Jul 6, 2016RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-001Dec 29, 19934,886,808► subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-003Sep 17, 20044,886,808► subscribe
Roche
KYTRIL
granisetron hydrochloride
TABLET;ORAL020305-002Jun 15, 19984,886,808► subscribe
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International Patent Family for Ingredient: granisetron hydrochloride

Country Document Number Estimated Expiration
Denmark0689437► subscribe
China1085079► subscribe
Taiwan312622► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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