ELACESTRANT DIHYDROCHLORIDE - Generic Drug Details

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

Elacestrant dihydrochloride is the generic ingredient in one branded drug marketed by Stemline Therap and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elacestrant dihydrochloride has one hundred and six patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for ELACESTRANT DIHYDROCHLORIDE

International Patents:	106
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	11
Patent Applications:	37
DailyMed Link:	ELACESTRANT DIHYDROCHLORIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 ELACESTRANT DIHYDROCHLORIDE

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

Sponsor	Phase
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3
Menarini Group	Phase 3
Breast International Group	Phase 3

See all ELACESTRANT DIHYDROCHLORIDE clinical trials

Pharmacology for ELACESTRANT DIHYDROCHLORIDE

Drug Class	Estrogen Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Estrogen Receptor Antagonists P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ELACESTRANT DIHYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No			Y	Y
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes

International Patents for ELACESTRANT DIHYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3288382	PROCÉDÉS DE TRAITEMENT DU CANCER (METHODS FOR TREATING CANCER)
South Korea	20180043202	암을 치료하는 방법
Finland	3122426
Israel	307983	שיטות לטיפול בסרטן (Methods of treating cancer)
Russian Federation	2747228	СПОСОБЫ ЛЕЧЕНИЯ РАКА (METHODS FOR TREATING CANCER)
Japan	2018518529	癌を治療するための方法

Supplementary Protection Certificates for ELACESTRANT DIHYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3122426	2024C/505	Belgium		PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	PA2024504	Lithuania		PRODUCT NAME: ELACESTRANTAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1757 20230915
3122426	301263	Netherlands		PRODUCT NAME: ELACESTRANT OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1757 20230918
3122426	LUC00331	Luxembourg		PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	CA 2024 00007	Denmark		PRODUCT NAME: ELACESTRANT OR A SALT THEREOF; REG. NO/DATE: EU/1/23/1757 20230918