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Last Updated: January 27, 2023

FASLODEX Drug Patent Profile


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When do Faslodex patents expire, and what generic alternatives are available?

Faslodex is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in FASLODEX is fulvestrant. There are twelve drug master file entries for this compound. Nineteen 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

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SponsorPhase
Adrienne G. WaksPhase 1/Phase 2
Verastem OncologyPhase 1/Phase 2
Eli Lilly and CompanyPhase 1/Phase 2

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Paragraph IV (Patent) Challenges for FASLODEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FASLODEX Injection fulvestrant 50 mg/mL, 2.5 mL and 5 mL syringe 021344 1 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 SOLUTION;INTRAMUSCULAR 021344-002 Apr 25, 2002 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 See Plans and Pricing See Plans and Pricing
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 See Plans and Pricing See Plans and Pricing
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 See Plans and Pricing See Plans and Pricing
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 See Plans and Pricing See Plans and Pricing
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for FASLODEX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan S.A.S Fulvestrant Mylan fulvestrant EMEA/H/C/004649
Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.
Authorised yes no no 2018-01-08
AstraZeneca AB Faslodex fulvestrant EMEA/H/C/000540
Faslodex is indicated, , , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy., , , in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy., , , In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.,
Authorised no no no 2004-03-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FASLODEX

See the table below for patents covering FASLODEX around the world.

Country Patent Number Title Estimated Expiration
Colombia 5280206 FORMULACION FARMACEUTICA DE LIBERACION SOSTENIDA ADAPTADA PARA ADMINISTRACION POR INYECCION See Plans and Pricing
United Kingdom 0100407 See Plans and Pricing
Taiwan I259086 See Plans and Pricing
Spain 2186517 FORMULACION FARMACEUTICA QUE CONTIENE FULVESTRANT. See Plans and Pricing
United Kingdom 0000313 See Plans and Pricing
Netherlands 300158 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FASLODEX

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

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