FULVESTRANT - Generic Drug Details

What are the generic sources for fulvestrant and what is the scope of freedom to operate?

Fulvestrant is the generic ingredient in two branded drugs marketed by Astrazeneca, Accord Hlthcare, Alembic, 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, Teva Pharms Usa Inc, Xiromed, and Zydus Pharms, and is included in eighteen 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. Twenty suppliers are listed for this compound.

Summary for FULVESTRANT

US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	398
Patent Applications:	6,820
Drug Prices:	Drug price trends for FULVESTRANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FULVESTRANT
What excipients (inactive ingredients) are in FULVESTRANT?	FULVESTRANT excipients list
DailyMed Link:	FULVESTRANT at DailyMed

See drug prices for FULVESTRANT

Recent Clinical Trials for FULVESTRANT

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

Sponsor	Phase
University of Washington	Phase 2
Merck Sharp & Dohme LLC	Phase 1/Phase 2
Nanjing Chia-tai Tianqing Pharmaceutical	Phase 1

See all FULVESTRANT clinical trials

Pharmacology for FULVESTRANT

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

Anatomical Therapeutic Chemical (ATC) Classes for FULVESTRANT

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

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
Eugia Pharma	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215169-001	Jun 30, 2023	AO	RX	No	No
Eugia Pharma	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	208811-001	Jul 23, 2019	AO	RX	No	No
Apotex	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	211730-001	Jun 11, 2021		DISCN	No	No

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
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002

EU/EMA Drug Approvals for FULVESTRANT

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