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Last Updated: April 25, 2024

Enzalutamide - Generic Drug Details

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What are the generic drug sources for enzalutamide and what is the scope of patent protection?

Enzalutamide is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, and Astellas, and is included in four 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 is one tentative approval for this compound.

Summary for enzalutamide

International Patents:	184
US Patents:	4
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	334
Patent Applications:	4,862
Formulation / Manufacturing:	see details
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
Lifespan	Phase 1
Legorreta Cancer Center at Brown University	Phase 1
Brown University	Phase 1

See all enzalutamide clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	80MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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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
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for enzalutamide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for enzalutamide

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Country	Patent Number	Title	Estimated Expiration
Portugal	3725778		⤷ Try a Trial
Russian Federation	2007146462	ДИАРИЛГИДАНТОИНЫ	⤷ Try a Trial
Singapore	10201408699T	DIARYLTHIOHYDANTOIN COMPOUNDS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for enzalutamide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	SPC/GB13/079	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196	122013000155	Germany	⤷ Try a Trial	PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	C20130036 00106	Estonia	⤷ Try a Trial	PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.