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Granisetron - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for granisetron?

Granisetron is the generic ingredient in six branded drugs marketed by Heron Theraps Inc, Kyowa Kirin, Roche, Sandoz Inc, West-ward Pharms Int, Taro, Akorn Inc, Barr, Fresenius Kabi Usa, Mylan, Hikma Farmaceutica, Sandoz, Pediatrx, Sagent Strides, Sagent Agila, Cipla Ltd, Aurobindo Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Mylan Labs Ltd, Corepharma, Bionpharma Inc, Teva Pharms Usa, Wockhardt Usa, Natco Pharma, Luitpold, Orchid Hlthcare, Teva Pharms, and Claris, and is included in forty-nine 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-three patent family members in thirty-two countries.

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

Summary for Generic Name: granisetron

Tradenames:6
Patents:8
Applicants:29
NDAs:49
Drug Master File Entries: see list26
Suppliers / Packagers: see list3
Bulk Api Vendors: see list53
Clinical Trials: see list35
Patent Applications: see list8,020
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:granisetron at DailyMed

Pharmacology for Ingredient: granisetron

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
TABLET;ORAL078221-001Dec 31, 2007DISCNNoNo► Subscribe► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-004Mar 11, 1994DISCNYesNo5,952,340► Subscribe ► Subscribe
Sandoz
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION078531-001Apr 30, 2009RXNoNo► Subscribe► Subscribe
Sagent Agila
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION091137-002Apr 9, 2010RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION077913-001Jun 26, 2008RXNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: granisetron

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,861,068 Pharmaceutical compositions using semi-solid delivery vehicle► Subscribe
8,252,306Process for preparing a semi-solid delivery vehicle comprising granisetron► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: granisetron

Country Document Number Estimated Expiration
Japan2017008113► Subscribe
World Intellectual Property Organization (WIPO)2006037116► Subscribe
Slovenia1589956► Subscribe
Japan2008514646► Subscribe
Japan2008514646► 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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