ENZALUTAMIDE - Generic Drug Details

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

Enzalutamide is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, Zydus Pharms, and Astellas, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Enzalutamide has one hundred and eighty-four patent family members in thirty-four countries.

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for ENZALUTAMIDE

International Patents:	184
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	342
Patent Applications:	3,887
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENZALUTAMIDE
What excipients (inactive ingredients) are in ENZALUTAMIDE?	ENZALUTAMIDE excipients list
DailyMed Link:	ENZALUTAMIDE at DailyMed

Recent Clinical Trials for ENZALUTAMIDE

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

Sponsor	Phase
University of Oklahoma	Phase 1
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

See all ENZALUTAMIDE clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL
		40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ENZALUTAMIDE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for ENZALUTAMIDE

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ENZALUTAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTANDI	Tablets	enzalutamide	40 mg and 80 mg	213674	1	2021-03-31
XTANDI	Capsules	enzalutamide	40 mg	203415	3	2016-08-31

US Patents and Regulatory Information for ENZALUTAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes			Y	Y
Zydus Pharms	ENZALUTAMIDE	enzalutamide	CAPSULE;ORAL	209667-001	Sep 26, 2024	AB	RX	No	No
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No			Y
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes

EU/EMA Drug Approvals for ENZALUTAMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Xtandi	enzalutamide	EMEA/H/C/002639 Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	Authorised	no	no	no	2013-06-21	2013-04-26

International Patents for ENZALUTAMIDE

Country	Patent Number	Title	Estimated Expiration
Norway	20170919	Diaryltiohydantoinforbindelser
Israel	187328	N-מתיל-2-פלואורו-{4-[3-(4-ציאנו-3-טריפלואורומתילפניל)-5,5-דימתיל-4-אוקסו-2-תיאוקסו-אימידאזולידינ-1-איל]}בנזאמיד, תכשירים רוקחים המכילים אותו ושימוש בו להכנת תרופות (N-methyl-2-fluoro-{4-[3-(4-cyano-3-trifluoromethylphenyl)-5,5-dimethyl-4-oxo-2-thioxo-imidazolidin-1-yl]}benzamide, pharmaceutical compositions comprising the same and uses thereof in the manufacture of medicaments)
South Africa	201201793	DIARYLHYDANTOIN COMPOUNDS
South Korea	20140041831	DIARYLHYDANTOIN COMPOUNDS
Ukraine	117353	ФОРМИ ДОЗУВАННЯ ЕНЗАЛУТАМІДУ (FORMULATIONS OF ENZALUTAMIDE)
Spain	2892029
Denmark	1893196

Supplementary Protection Certificates for ENZALUTAMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	92338	Luxembourg		PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196	2013/061	Ireland		PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	CR 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196	122013000155	Germany		PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	PA2013029	Lithuania		PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	2013C/074	Belgium		PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1893196	C20130036 00106	Estonia		PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013