Elacestrant Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as STEMLINE THERAP. It is marketed under 1 brand name, including ORSERDU. Available in 2 different strengths, such as EQ 86MG BASE, EQ 345MG BASE, and administered through 1 route including TABLET;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength	Route of Administration	Companies	Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

	Patent Number	Publication Date	Legal Status	Patent Expiry Date
{"application_id":"111345","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"c58f5061372a4f16bd94","publication_number":"US8399520B2","cleaned_patent_number":"8399520","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-25","publication_date":"2013-03-19","legal_status":"Expired"}	US8399520B2 Molecular Formulation	19 Mar, 2013	Expired	25 Dec, 2025
{"application_id":"112302","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"c58f5061372a4f16bd94","publication_number":"US7612114B2","cleaned_patent_number":"7612114","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-08-18","publication_date":"2009-11-03","legal_status":"Patented case"}	US7612114B2 Molecular Formulation	03 Nov, 2009	Patented case	18 Aug, 2026
{"application_id":"111344","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"907444d5a949422395c1","publication_number":"US10071066B2","cleaned_patent_number":"10071066","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2018-09-11","legal_status":"Granted"}	US10071066B2	11 Sep, 2018	Granted	10 Oct, 2034
{"application_id":"112362","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"a59fa71518d948e09005","publication_number":"US11779552B2","cleaned_patent_number":"11779552","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2023-10-10","legal_status":"Granted"}	US11779552B2	10 Oct, 2023	Granted	10 Oct, 2034
{"application_id":"112349","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"907444d5a949422395c1","publication_number":"US10420734B2","cleaned_patent_number":"10420734","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2019-09-24","legal_status":"Granted"}	US10420734B2	24 Sep, 2019	Granted	10 Oct, 2034
{"application_id":"112226","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"f8c5c1244f314ab2b0bf","publication_number":"US11819480B2","cleaned_patent_number":"11819480","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-29","publication_date":"2023-11-21","legal_status":"Granted"}	US11819480B2	21 Nov, 2023	Granted	29 Nov, 2036
{"application_id":"111343","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"ffd01f862b2343f4bafb","publication_number":"US10745343B2","cleaned_patent_number":"10745343","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-05","publication_date":"2020-08-18","legal_status":"Granted"}	US10745343B2	18 Aug, 2020	Granted	05 Jan, 2038
{"application_id":"112257","ingredient":"ELACESTRANT HYDROCHLORIDE","trade_name":"ORSERDU","family_id":"ffd01f862b2343f4bafb","publication_number":"US10385008B2","cleaned_patent_number":"10385008","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-05","publication_date":"2019-08-20","legal_status":"Granted"}	US10385008B2 Molecular Formulation	20 Aug, 2019	Granted	05 Jan, 2038

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID	Title	Status	Phase	Conditions	Start Date	Completion Date

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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.