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Last Updated: April 29, 2024

Elacestrant dihydrochloride - Generic Drug Details

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What are the generic 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 five patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for elacestrant dihydrochloride

International Patents:	105
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

Generic Entry Date for elacestrant dihydrochloride^: ⤷ Try a Trial* 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
Menarini Group	Phase 3
Breast International Group	Phase 3
European Organisation for Research and Treatment of Cancer - EORTC	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

Anatomical Therapeutic Chemical (ATC) Classes for elacestrant dihydrochloride

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for elacestrant dihydrochloride

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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
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	⤷ 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

International Patents for elacestrant dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
Japan	2018514593	癌を治療するための方法	⤷ Try a Trial
Israel	255189	צירוף של rad1901 ומעכב cdk4/6 לשימוש בטיפול בסרטן (A combination of rad1901 and a cdk4/6 inhibitor for use in treating cancer)	⤷ Try a Trial
Israel	310069	שיטות לטיפול בסרטן (Methods of treating cancer)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for elacestrant dihydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3122426	LUC00331	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	PA2024504	Lithuania	⤷ Try a Trial	PRODUCT NAME: ELACESTRANTAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1757 20230915
3122426	2024C/505	Belgium	⤷ Try a Trial	PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
>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.