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KYTRIL Drug Profile

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Kytril is a drug marketed by Roche and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Summary for Tradename: KYTRIL

Patents:1
Applicants:1
NDAs:3
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche
KYTRIL
granisetron hydrochloride
TABLET;ORAL020305-001Mar 16, 1995DISCNNo► subscribe► subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-002Mar 11, 1994DISCNNo5,952,340► subscribe ► subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-003Sep 17, 2004DISCNNo► subscribe► subscribe
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Expired Patents for Tradename: KYTRIL

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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Paragraph IV activity for: KYTRIL

Drugname Dosage Strength RLD Submissiondate
granisetron hydrochlorideInjection0.1 mg/mL, 1 mL single dose vialKytril3/8/2007
granisetron hydrochlorideInjection1 mg/mL, 4 mL multi-dose vialsKytril7/19/2004
granisetron hydrochlorideInjection1 mg/mL, 1 mL vialsKytril6/1/2004

International Patent Family for Tradename: KYTRIL

Country Document Number Estimated Expiration
HungaryT73502► subscribe
South Africa9401844► subscribe
United Kingdom9305593► 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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