Apalutamide - Generic Drug Details

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

Apalutamide is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apalutamide has two hundred and fifty-seven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for apalutamide

International Patents:	257
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	108
Patent Applications:	1,736
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apalutamide
What excipients (inactive ingredients) are in apalutamide?	apalutamide excipients list
DailyMed Link:	apalutamide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for apalutamide

Generic Entry Date for apalutamide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for apalutamide

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 2
Prostate Cancer Foundation	Phase 2
University of Cincinnati	Phase 2

See all apalutamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for apalutamide

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

Paragraph IV (Patent) Challenges for APALUTAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERLEADA	Tablets	apalutamide	60 mg	210951	5	2022-02-14

US Patents and Regulatory Information for apalutamide

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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
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		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 apalutamide

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Erleada	apalutamide	EMEA/H/C/004452 Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).	Authorised	no	no	no	2019-01-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for apalutamide

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Country	Patent Number	Title	Estimated Expiration
Japan	2020536965	非転移性去勢抵抗性前立腺癌の治療のための抗アンドロゲン剤	⤷ Try a Trial
Philippines	12018502569	ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER	⤷ Try a Trial
Poland	2656842		⤷ Try a Trial
Japan	7257692		⤷ Try a Trial
Canada	3079135	ANTI-ANDROGENES DESTINES AU TRAITEMENT DU CANCER DE LA PROSTATE RESISTANT A LA CASTRATION, NON METASTATIQUE (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER)	⤷ Try a Trial
Croatia	P20201387		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for apalutamide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368550	1990032-3	Sweden	⤷ Try a Trial	PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116
3533792	CA 2021 00041	Denmark	⤷ Try a Trial	PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550	2019/032	Ireland	⤷ Try a Trial	PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550	2019C/529	Belgium	⤷ Try a Trial	PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
3533792	C202130058	Spain	⤷ Try a Trial	PRODUCT NAME: APALUTAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
3533792	301144	Netherlands	⤷ Try a Trial	PRODUCT NAME: APALUTAMIDE; REGISTRATION NO/DATE: EU/1/18/1342 20190116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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