You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: February 29, 2024

FASLODEX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Twenty 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.

  Try a Trial

Drug patent expirations by year for FASLODEX
Drug Prices for FASLODEX

See drug prices for FASLODEX

Recent Clinical Trials for FASLODEX

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

SponsorPhase
Relay Therapeutics, Inc.Phase 1
Adrienne G. WaksPhase 1/Phase 2
Scorpion Therapeutics, Inc.Phase 1/Phase 2

See all FASLODEX clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca FASLODEX fulvestrant SOLUTION;INTRAMUSCULAR 021344-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
>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 Pharmaceuticals Limited 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

Supplementary Protection Certificates for FASLODEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138504 300158 Netherlands ⤷  Try a Trial 300158, 20041002, EXPIRES: 20091001
0138504 2004C/004 Belgium ⤷  Try a Trial PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
0138504 91068 Luxembourg ⤷  Try a Trial 91068, EXPIRES: 20091002
0138504 SPC/GB04/009 United Kingdom ⤷  Try a Trial 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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.