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Boehringer Ingelheim
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Last Updated: December 9, 2021

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FASLODEX Drug Patent 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.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Faslodex

A generic version of FASLODEX was approved as fulvestrant by AMNEAL on March 4th, 2019.

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Drug patent expirations by year for FASLODEX
Drug Prices for FASLODEX

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Recent Clinical Trials for FASLODEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CelcuityPhase 2
Celcuity, Inc.Phase 2
Medical College of WisconsinPhase 1

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Paragraph IV (Patent) Challenges for FASLODEX
Tradename Dosage Ingredient NDA Submissiondate
FASLODEX INJECTABLE;INTRAMUSCULAR fulvestrant 021344 2009-10-01

US Patents and Regulatory Information for FASLODEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FASLODEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try it Free ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try it Free ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try it Free ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try it Free ⤷  Try it Free
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FASLODEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138504 91068 Luxembourg ⤷  Try it Free 91068, EXPIRES: 20091002
0138504 2004C/004 Belgium ⤷  Try it Free PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
0138504 300158 Netherlands ⤷  Try it Free 300158, 20041002, EXPIRES: 20091001
0138504 SPC/GB04/009 United Kingdom ⤷  Try it Free PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Merck
Boehringer Ingelheim
Moodys
McKinsey

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