Apalutamide - Generic Drug Details

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

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

Apalutamide has two hundred and eighty-seven patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for apalutamide

International Patents:	287
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	111
Patent Applications:	1,411
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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,481,663 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
Prostate Cancer Foundation	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Xian-Janssen Pharmaceutical Ltd.	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	No	RE49353	⤷ Subscribe				⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	10,849,888	⤷ Subscribe				⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	10,702,508	⤷ Subscribe				⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	8,445,507	⤷ Subscribe	Y	Y		⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	9,987,261	⤷ Subscribe	Y			⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	8,802,689	⤷ Subscribe				⤷ Subscribe
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	11,963,952	⤷ Subscribe				⤷ Subscribe
>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
Peru	20150631	FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO	⤷ Subscribe
Poland	2858985		⤷ Subscribe
Eurasian Patent Organization	202190820	АНТИАНДРОГЕНЫ ДЛЯ ЛЕЧЕНИЯ НЕМЕТАСТАТИЧЕСКОГО КАСТРАЦИОННО-РЕЗИСТЕНТНОГО РАКА ПРОСТАТЫ	⤷ Subscribe
Lithuania	C2368550		⤷ Subscribe
Australia	2007243651	Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases	⤷ Subscribe
Australia	2024204555		⤷ Subscribe
Taiwan	201916878		⤷ Subscribe
>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	35/2019	Austria	⤷ Subscribe	PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
2368550	1990032-3	Sweden	⤷ Subscribe	PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116
2368550	PA2019512	Lithuania	⤷ Subscribe	PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550	CR 2019 00029	Denmark	⤷ Subscribe	PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550	132019000000084	Italy	⤷ Subscribe	PRODUCT NAME: APALUTAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116
2368550	LUC00123	Luxembourg	⤷ Subscribe	PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
3533792	2021046	Norway	⤷ Subscribe	PRODUCT NAME: APALUTAMIDE; NAT. REG. NO/DATE: 18/02193 20190123; FIRST REG. NO/DATE: 1/18/1342 20190116
>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.