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Famciclovir - Generic Drug Details

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Famciclovir is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Macleods Pharms Ltd, Roxane, Mylan, Hetero Labs Ltd V, Novartis, Cipla Ltd, Apotex, and Teva Pharms, and is included in nine NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-eight patent family members in twenty-eight countries.

There are eight drug master file entries for famciclovir. Nineteen suppliers are listed for this compound.

Summary for Generic Name: famciclovir

Tradenames:2
Patents:2
Applicants:9
NDAs:9
Drug Master File Entries: see list8
Suppliers / Packaging: see list19
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex
FAMCICLOVIR
famciclovir
TABLET;ORAL091480-002Jul 22, 2011RXNo► subscribe► subscribe
Macleods Pharms Ltd
FAMCICLOVIR
famciclovir
TABLET;ORAL201022-003Jan 12, 2012RXNo► subscribe► subscribe
Aurobindo Pharma Ltd
FAMCICLOVIR
famciclovir
TABLET;ORAL091114-002Mar 21, 2011RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: famciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-003Dec 11, 19956,124,304*PED► subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-003Dec 11, 19955,916,893*PED► subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-002Jun 29, 19945,246,937*PED► subscribe
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International Patent Family for Ingredient: famciclovir

Country Document Number Estimated Expiration
Hungary222835► subscribe
New Zealand297424► subscribe
Bulgaria101608► 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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Supplementary Protection Certificates for Tradename: FAMCICLOVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036Belgium► subscribePRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
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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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