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. 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 4^th, 2019.

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Summary for FASLODEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	165
Patent Applications:	3,851
Drug Prices:	Drug price information for FASLODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FASLODEX
What excipients (inactive ingredients) are in FASLODEX?	FASLODEX excipients list
DailyMed Link:	FASLODEX at DailyMed

Drug patent expirations by year for FASLODEX

Recent Clinical Trials for FASLODEX

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
University of Washington	Phase 2
Carrick Therapeutics Limited	Phase 2

See all FASLODEX clinical trials

Pharmacology for FASLODEX

Drug Class	Estrogen Receptor Antagonist
Mechanism of Action	Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	AO	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FASLODEX

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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

International Patents for FASLODEX

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

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Country	Patent Number	Title	Estimated Expiration
Slovakia	9842002	Fulvestrant formulation	⤷ Sign Up
Bulgaria	106833		⤷ Sign Up
Italy	TO20010005		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FASLODEX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138504	91068	Luxembourg	⤷ Sign Up	91068, EXPIRES: 20091002
0138504	300158	Netherlands	⤷ Sign Up	300158, 20041002, EXPIRES: 20091001
0138504	2004C/004	Belgium	⤷ Sign Up	PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description