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FASLODEX Drug Profile

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Faslodex is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in thirty-eight countries.

The generic ingredient in FASLODEX is fulvestrant. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fulvestrant profile page.

Summary for Tradename: FASLODEX

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: FASLODEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
FASLODEX
fulvestrant
INJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYes6,774,122*PED► subscribeY► subscribe
Astrazeneca
FASLODEX
fulvestrant
INJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYes8,466,139*PED► subscribeY► subscribe
Astrazeneca
FASLODEX
fulvestrant
INJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYes7,456,160*PED► subscribeY► subscribe
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Expired Patents for Tradename: FASLODEX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
FASLODEX
fulvestrant
INJECTABLE;INTRAMUSCULAR021344-001Apr 25, 20024,659,516► subscribe
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Paragraph IV activity for: FASLODEX

Drugname Dosage Strength RLD Submissiondate
fulvestrantInjection50 mg/mL, 2.5 mL and 5 mL syringeFaslodex10/1/2009

International Patent Family for Tradename: FASLODEX

Country Document Number Estimated Expiration
European Patent Office1669073► subscribe
Norway337329► subscribe
Norway336286► 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: FASLODEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
04C/004Belgium► subscribePRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
C/GB04/009United Kingdom► subscribePRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
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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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