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Last Updated: January 27, 2023

Fulvestrant - Generic Drug Details


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What are the generic sources for fulvestrant and what is the scope of patent protection?

Fulvestrant is the generic ingredient in two branded drugs marketed by Astrazeneca, Accord Hlthcare, Amneal, Apotex, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa Inc, Xiromed, and Zydus Pharms, and is included in sixteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for fulvestrant. Nineteen suppliers are listed for this compound.

Drug Prices for fulvestrant

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Recent Clinical Trials for fulvestrant

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

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

See all fulvestrant clinical trials

Paragraph IV (Patent) Challenges for FULVESTRANT
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 fulvestrant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Inc FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 207754-001 Aug 22, 2019 AO RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chia Tai Tianqing FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 211422-001 Feb 7, 2020 AO RX No 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
Sagent Pharms Inc FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 205871-001 Aug 22, 2019 AO RX No No 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 fulvestrant

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for fulvestrant

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

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