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Granisetron hydrochloride - Generic Drug Details

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

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by 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-seven NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Granisetron hydrochloride 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:2
Applicants:27
NDAs:47
Drug Master File Entries: see list26
Suppliers / Packagers: see list18
Bulk Api Vendors: see list62
Clinical Trials: see list1,021
Patent Applications: see list2,379
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:granisetron hydrochloride at DailyMed

Pharmacology for Ingredient: granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION078534-001Apr 30, 2009RXNoNo► Subscribe► Subscribe
Cipla Ltd
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION078258-001Jun 30, 2008RXNoNo► Subscribe► Subscribe
Sagent Strides
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION091136-002Apr 9, 2010RXNoNo► Subscribe► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-001Dec 29, 1993DISCNYesNo5,952,340► Subscribe ► Subscribe
Hikma Farmaceutica
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
INJECTABLE;INJECTION078629-002Dec 23, 2009RXNoNo► 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
TABLET;ORAL020305-001Mar 16, 19954,886,808► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-002Mar 11, 19945,952,340► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-004Mar 11, 19945,952,340► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-002Mar 11, 19944,886,808► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-001Dec 29, 19935,952,340► Subscribe
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International Patent Family for Ingredient: granisetron hydrochloride

Country Document Number Estimated Expiration
Australia676032► Subscribe
Hungary9502692► Subscribe
Singapore46724► Subscribe
Australia6377494► Subscribe
Canada2158354► 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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