Acoramidis hydrochloride - Generic Drug Details

What are the generic drug sources for acoramidis hydrochloride and what is the scope of patent protection?

Acoramidis hydrochloride is the generic ingredient in one branded drug marketed by Bridgebio Pharma and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acoramidis hydrochloride has one hundred and twenty patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for acoramidis hydrochloride

International Patents:	120
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acoramidis hydrochloride
What excipients (inactive ingredients) are in acoramidis hydrochloride?	acoramidis hydrochloride excipients list
DailyMed Link:	acoramidis hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

11,260,047

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 acoramidis hydrochloride

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

Sponsor	Phase
Bayer	PHASE4
Eidos Therapeutics, a BridgeBio company	PHASE3
Alexion Pharmaceuticals	Phase 1

See all acoramidis hydrochloride clinical trials

Pharmacology for acoramidis hydrochloride

Drug Class	Transthyretin Stabilizer
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Transthyretin Stabilizers

Anatomical Therapeutic Chemical (ATC) Classes for acoramidis hydrochloride

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for acoramidis hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	10,842,777
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	8,877,795		Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	12,070,449
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	9,169,214		Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	11,058,668

International Patents for acoramidis hydrochloride

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120543
Cyprus	2025010
Denmark	2934514
European Patent Office	2934514	STABILISANTS DE TRANSTHYRÉTINE ET LEUR UTILISATION POUR INHIBER L'AMYLOSE DE LA TRANSTHYRÉTINE ET LES INTERACTIONS PROTÉINE-PROTÉINE (TRANSTHYRETIN STABILIZERS AND THEIR USE FOR INHIBITING TRANSTHYRETIN AMYLOIDOSIS AND PROTEIN-PROTEIN INTERACTIONS)
Spain	2683994
Finland	C20250016
France	25C1011

Supplementary Protection Certificates for acoramidis hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2934514	PA2025512,C2934514	Lithuania		PRODUCT NAME: AKORAMIDIS IR/ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPACAKORAMIDZIO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/24/1906 20250210
2934514	PA2025512	Lithuania		PRODUCT NAME: AKORAMIDIS IR/ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPACAKORAMIDZIO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/24/1906 20250210
2934514	25C1011	France		PRODUCT NAME: ACORAMIDIS; REGISTRATION NO/DATE: EU/1/24/1906 20250211
2934514	LUC50002	Luxembourg		PRODUCT NAME: ACORAMIDIS, ET/OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE CHLORHYDRATE D'ACORAMIDIS; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250210
2934514	301323	Netherlands		PRODUCT NAME: ACORAMIDIS EN/OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ACORAMIDISHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1906 20250211
2934514	CA 2025 00013	Denmark		PRODUCT NAME: ACORAMIDIS, AND/OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY ACORAMIDIS HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1906 20250211
2934514	C202530015	Spain		PRODUCT NAME: ACORAMIDIS Y/O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, ESPECIALMENTEHIDROCLORURO DE ACORAMIDIS; NATIONAL AUTHORISATION NUMBER: EU/1/24/1906; DATE OF AUTHORISATION: 20250210; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1906; DATE OF FIRST AUTHORISATION IN EEA: 20250210