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Last Updated: August 11, 2020

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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, Amneal, Chia Tai Tianqing, Glenmark Pharms Inc, Hbt Labs Inc, Mylan Institutional, Sagent Pharms Inc, Sandoz Inc, Fresenius Kabi Usa, and Teva Pharms Usa Inc, and is included in ten NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fulvestrant has seventy-one patent family members in forty countries.

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

Drug Prices for fulvestrant

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Recent Clinical Trials for fulvestrant

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SponsorPhase
BayerPhase 1
Fundacion CRIS de Investigación para Vencer el CáncerPhase 1
Apices Soluciones S.L.Phase 1

See all fulvestrant clinical trials

Paragraph IV (Patent) Challenges for FULVESTRANT
Tradename Dosage Ingredient NDA Submissiondate
FASLODEX INJECTABLE;INTRAMUSCULAR fulvestrant 021344 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
Fresenius Kabi Usa FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210326-001 May 20, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
Hbt Labs Inc FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 209714-001 Nov 21, 2019 AO RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210326-001 May 20, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for fulvestrant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138504 2004C/004 Belgium   Start Trial PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
0138504 SPC/GB04/009 United Kingdom   Start 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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Dow
Moodys
Harvard Business School
Express Scripts

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