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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Moodys
Dow
McKesson
US Department of Justice
Healthtrust
Teva
US Army
Cipla

Generated: December 15, 2017

DrugPatentWatch Database Preview

FASLODEX Drug Profile

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Which patents cover Faslodex, and what generic alternatives are available?

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

This drug has seventy-one patent family members in forty countries and two supplementary protection certificates in two countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AstrazenecaFASLODEXfulvestrantINJECTABLE;INTRAMUSCULAR021344-001Apr 25, 2002RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Denmark1250138► Subscribe
Estonia05421► Subscribe
MexicoPA02006698► Subscribe
China1394141► Subscribe
Slovenia1250138► Subscribe
European Patent Office1669073► Subscribe
Iceland6454► Subscribe
Spain2248272► Subscribe
Cyprus1116520► Subscribe
Norway20150741► 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
C/GB04/009United Kingdom► SubscribePRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
04C/004Belgium► SubscribePRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
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Serving leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Fuji
Boehringer Ingelheim
Healthtrust
Baxter
Cipla
Julphar
Novartis
Harvard Business School

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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