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Last Updated: October 22, 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, Dr Reddys, 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 eleven 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. Fourteen 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
Criterium, Inc.Phase 2
QED Therapeutics, Inc.Phase 1
Stanford UniversityPhase 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
Chia Tai Tianqing FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 211422-001 Feb 7, 2020 AO RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Institutional FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 208811-001 Jul 23, 2019 AO RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 209246-001 Aug 7, 2020 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
Teva Pharms Usa Inc FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210063-001 Aug 19, 2019 RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial   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:

Baxter
McKinsey
Mallinckrodt
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Merck
AstraZeneca

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