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 twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for acoramidis hydrochloride

International Patents:	103
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
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:

TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS(ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR DEATH AND CARDIOVASCULAR-RELATED HOSPITALIZATION

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
Eidos Therapeutics, a BridgeBio company	PHASE3
Celerion	Phase 1
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			Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes			Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes				Y
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			Y

International Patents for acoramidis hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2019239291
Brazil	112020026493
Eurasian Patent Organization	201991921
Mexico	2019009764
New Zealand	768103	Methods of treating ttr amyloidosis using ag10
European Patent Office	2566333	IDENTIFICATION DE STABILISANTS DE PROTÉINES MULTIMÉRIQUES (IDENTIFICATION OF STABILIZERS OF MULTIMERIC PROTEINS)

Supplementary Protection Certificates for acoramidis hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2934514	PA2025512	Lithuania		PRODUCT NAME: AKORAMIDIS IR/ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPACAKORAMIDZIO HIDROCHLORIDAS; REGISTRATION NO/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	14/2025	Austria		PRODUCT NAME: ACORAMIDIS UND/ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ACORAMIDISHYDROCHLORID; REGISTRATION NO/DATE: EU/1/24/1906 (MITTEILUNG) 20250211
2934514	2025C/515	Belgium		PRODUCT NAME: ACORAMIDIS EN/OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, MET NAME ACORAMIDISHYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250211
2934514	2590011-9	Sweden		PRODUCT NAME: ACORAMIDIS, AND/OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY ACORAMIDIS HYDROCHLORIDE; REG. 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

Market Dynamics and Financial Trajectory for Acoramidis Hydrochloride

Last updated: July 29, 2025

Introduction

Acoramidis Hydrochloride, a promising investigational drug targeting transthyretin amyloidosis (ATTR), is poised to reshape the therapeutic landscape for this rare but debilitating condition. Its unique mechanism of stabilizing transthyretin (TTR) protein to prevent amyloid fibril formation offers a targeted approach, aligning with the burgeoning trend toward precision medicine in neurodegenerative and systemic amyloid diseases. Understanding the evolving market dynamics and projected financial trajectory of acoramidis is crucial for stakeholders, including pharmaceutical developers, investors, and healthcare providers.

Market Background and Disease Burden

Transthyretin amyloidosis is a rare, progressive disorder characterized by abnormal buildup of amyloid fibrils derived from misfolded TTR proteins. The disease manifests primarily as hereditary familial amyloid polyneuropathy (FAP) and wild-type amyloid cardiomyopathy (ATTR-CM). According to the Amyloidosis Research Consortium, the global prevalence of ATTR is estimated at approximately 50,000 to 100,000 patients, with underdiagnosis being a significant barrier (1). As diagnostic techniques improve, notably via advanced imaging and genetic testing, market penetration for TTR stabilizers like acoramidis is expected to increase.

The high unmet need, coupled with the lack of curative therapies—existing options being limited and often palliative—positions acoramidis as a potentially transformative agent. The current market primarily revolves around its competitors, notably patisiran and inotersen, which target TTR through gene silencing rather than stabilization.

Clinical Development and Regulatory Pathway

Acoramidis (formerly AG10) has demonstrated promising Phase 2 and Phase 3 clinical trial results, indicating significant stabilization of TTR and potential improvement in disease symptoms (2). The ATTRibute-CM Phase 3 trial, completed recently, showed durable cardiac function stabilization in patients with ATTR-CM, paving the way for regulatory submission.

The FDA and EMA approvals, anticipated within the next 12-18 months, are critical inflection points influencing market entry, reimbursement, and commercial success. Given the rare-disease status and orphan drug designations, acoramidis could benefit from expedited review pathways, market exclusivity, and pricing premiums.

Market Dynamics

Competitive Landscape

A prominent feature shaping acoramidis’s market trajectory is its competition with existing therapies. Patisiran (ALN-TTR02) and inotersen target TTR gene expression via RNA interference and antisense oligonucleotides, respectively, demonstrating efficacy but with notable side effects such as hepatotoxicity and thrombocytopenia (3). Conversely, acoramidis's stabilization approach could offer a safety profile advantage, fostering acceptance among clinicians.

Emerging therapies, including gene-editing candidates, are also on the horizon, although these are early-stage and less likely to impact the market within the immediate timeframe.

Pricing and Reimbursement

Pricing strategies for acoramidis will crucially influence market penetration. Orphan drugs typically command premium pricing, justified by high development costs and limited patient populations. Based on comparable agents, annual treatment costs could range from $150,000 to $300,000 per patient (4). Reimbursement negotiations, healthcare system adoption, and patient access programs will substantially affect revenue realization.

Market Adoption Factors

Physician familiarity, diagnostic advancements, and early intervention are critical to market penetration. Continued education about the benefits of molecular stabilization over gene silencing, along with robust clinical data, will enhance clinician confidence and adoption rates.

Geographic Expansion

Initially launching in North America and Europe—with well-established healthcare systems—Acoramidis is likely to expand into Asian markets, such as Japan, where amyloidosis prevalence is significant but underdiagnosed. The strategic approach to geographic expansion will influence revenue streams substantially.

Financial Trajectory

Revenue Forecast

Assuming successful regulatory approval by Q2 2024, early commercialization could generate revenues in the range of $50-100 million in the first year, based on initial diagnosed patient volumes and conservative market penetration estimates (5). With increasing diagnostic capacity and expanding clinical adoption, revenues could escalate to over $1 billion annually within five years, contingent upon marketing effectiveness and payer acceptance.

Cost Structure and Investment

Development costs for acoramidis, including clinical trials, regulatory submissions, and commercialization, are estimated at approximately $300-500 million cumulatively (6). Ongoing investments into post-marketing studies, pharmacovigilance, and market expansion are expected.

Profitability Outlook

Given the high unmet need and premium pricing potential, profitability hinges on achieving scalable market penetration and managing manufacturing costs. Margins are projected to improve as production scales and as the competitive landscape stabilizes.

Investment and Market Valuation

Investors view acoramidis as a high-growth asset with substantial upside potential. The valuation of the developing company could reach several billion dollars pre-commercialization, driven by the drug’s likelihood of regulatory approval and market exclusivity.

Challenges and Risks

• Regulatory Delays or Rejection: Any issues in trial data interpretation or regulatory review could delay market entry.
• Market Penetration Barriers: Underdiagnosis of ATTR may limit immediate uptake.
• Pricing and Reimbursement: Healthcare payer restrictions can impact revenue.
• Competitive Pressure: Emergence of alternative therapies might erode market share.

Conclusion

Acoramidis hydrochloride's market dynamics are characterized by high unmet medical need, promising clinical data, and a strategic regulatory pathway that support a favorable financial trajectory. Its potential to become a first-in-class TTR stabilizer, coupled with strategic differentiation, positions acoramidis for substantial market capture and financial success, provided that clinical efficacy, regulatory approval, and payer acceptance are achieved.

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Key Takeaways

• Strong Market Potential: Targeting a rare, underserved disease with high unmet need enhances acoramidis's commercial prospects.
• Regulatory Milestones are Crucial: Successful approval within the next 12-18 months is expected to significantly impact revenue projections.
• Pricing Strategy Drives Revenue: Premium pricing aligned with orphan drug status and reimbursement negotiations will influence market penetration.
• Clinical Differentiation: Its TTR stabilization mechanism may offer safety and efficacy advantages over competitors, supporting adoption.
• Global Expansion Opportunities: European and Asian markets represent significant expansion avenues, improving long-term financial outlook.

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FAQs

1. When is acoramidis expected to receive regulatory approval?
Acoramidis is anticipated to submit for regulatory approval by mid-2023, with approvals projected within 12-18 months post-submission, contingent on clinical trial data review.

2. How does acoramidis differ from existing TTR therapies?
Unlike gene-silencing agents such as patisiran and inotersen, acoramidis stabilizes TTR protein directly, potentially offering a better safety profile and requiring less frequent dosing.

3. What is the projected market size for acoramidis?
Initially targeting approximately 10,000 diagnosed ATTR patients in North America and Europe, with potential growth as diagnostics improve, expanding market size significantly over the next decade.

4. How will pricing impact acoramidis’s financial success?
Premium pricing, typical for orphan drugs (around $150,000–$300,000 annually), combined with favorable reimbursement strategies, will drive revenue, but may face payer resistance depending on demonstrated value.

5. What are the primary risks associated with acoramidis’s market trajectory?
Regulatory delays, unforeseen safety issues, slow adoption due to diagnostic challenges, and competitive therapies emerging are key risks impacting its financial outlook.