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 and Astellas, and is included in three NDAs. There are three 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 thirty-three patent family members in twenty-eight countries.

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

Summary for enzalutamide

International Patents:	133
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	310
Patent Applications:	5,423
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
Nuvation Bio Inc.	Phase 1/Phase 2
Fudan University	Phase 2
Curium US LLC	Phase 3

See all enzalutamide clinical trials

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	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Actavis Labs Fl Inc	ENZALUTAMIDE	enzalutamide	CAPSULE;ORAL	209614-001	May 14, 2021		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for enzalutamide

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	92338		See Plans and Pricing
Serbia	52274	JEDINJENJE DIARILHIDANTOINA (DIARZLHZDANTOIN COMPOUND)	See Plans and Pricing
Japan	2017031224	ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)	See Plans and Pricing
Hong Kong	1177691	二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)	See Plans and Pricing
>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	PA2013029,C1893196	Lithuania	See Plans and Pricing	PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	92338	Luxembourg	See Plans and Pricing	PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196	PA2013029	Lithuania	See Plans and Pricing	PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	70/2013	Austria	See Plans and Pricing	PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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