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 five patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for acoramidis hydrochloride

International Patents:	105
US Patents:	12
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:

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
Bayer	PHASE4
Eidos Therapeutics, a BridgeBio company	PHASE3
Celerion	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	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	11,260,047		Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	10,513,497			Y

International Patents for acoramidis hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	202092272	СПОСОБЫ ЛЕЧЕНИЯ ТРАНСТИРЕТИНОВОГО АМИЛОИДОЗА С ПРИМЕНЕНИЕМ AG10
Portugal	2934514
Mexico	388841
European Patent Office	3768841	MÉTHODES DE TRAITEMENT DE L'AMYLOSE TTR À L'AIDE D'AG10 (METHODS OF TREATING TTR AMYLOIDOSIS USING AG10)
Finland	C20250016

Supplementary Protection Certificates for acoramidis hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	C20250016	Finland
2934514	CR 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: February 15, 2026

Acoramidis hydrochloride, a next-generation transthyretin stabilizer developed for ATTR amyloidosis treatment, is progressing through clinical and regulatory pathways that influence its market potential. Its unique mechanism, targeting transthyretin stabilization, positions it in a niche with unmet medical needs. The following analysis assesses its current state, competitive landscape, regulatory environment, and financial prospects.

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Clinical Development and Regulatory Pathway

Acoramidis (AG10) is an oral small-molecule stabilized transthyretin (TTR) amyloid inhibitor. Its developer, Eidos Therapeutics (a Pfizer subsidiary), has advanced it through Phase 3 trials. Phase 3 ATTR-ACT trial results demonstrated improvement in disease progression and quality of life for transthyretin amyloid cardiomyopathy (ATTR-CM).

In November 2022, Eidos submitted a New Drug Application (NDA) to the FDA for acoramidis. Regulatory reviews are ongoing, with a PDUFA date set for January 2024. European submission follow-up is expected in H1 2024, pending EMA review.

Market Size and Segmentation

The ATTR amyloidosis market is segmented into hereditary ("hATTR") and wild-type ("wtATTR") forms, with the latter representing the majority of diagnosed cases. Estimates predict:

• Global ATTR amyloidosis prevalence: approximately 50,000 to 70,000 patients.
• ATTR-CM prevalence: around 40,000 patients worldwide.
• Diagnosed vs. undiagnosed: Underdiagnosis remains significant; only 10-15% of eligible patients are diagnosed due to lack of awareness and detection challenges.

Pricing and reimbursement strategies will significantly influence revenue potential.

Competitive Landscape

Current standard treatments include:

• Tafamidis (Vyndaqel/Vyndamax): Approved for ATTR-CM in multiple regions, with peak sales exceeding $1 billion annually. It functions as a transthyretin stabilizer similar to acoramidis but has shown limited efficacy in advanced disease stages.
• Patisiran and Inotersen: RNA interference therapies approved for hATTR polyneuropathy, with limited applicability in cardiomyopathy.

Acoramidis distinguishes itself with higher potency in stabilizing TTR and improved pharmacokinetics. Early data suggest better efficacy in slowing disease progression.

Market Entry Timing and Revenue Projections

If approved by early 2024, commercial launch could begin in the US and Europe within 6-12 months. Adoption depends on:

• Pricing strategy: Estimated at $150,000–$200,000 per year.
• Market penetration: Initial targeting of diagnosed patients, with expansion as awareness increases.

Based on competitive pricing and adoption rates, revenue projections are:

Year	Estimated Patients Treated	Assumed Market Share	Revenue (USD millions)
2024	2,000	10%	$300–$400
2025	6,000	30%	$900–$1,200
2026	10,000	50%	$1,500–$2,000

These figures assume gradual market penetration and no significant pricing pressures.

Intellectual Property and Patent Landscape

Acoramidis holds multiple patents covering its chemical structure and specific indications, extending protection into the late 2030s. Patent expirations could open generic competition in the late 2030s, potentially affecting long-term pricing power.

Financial Trajectory

Eidos Therapeutics incurred R&D costs exceeding $180 million over the past five years to develop acoramidis. The NDA filing and subsequent commercialization will increase operating expenses but also generate revenue streams.

• Pre-approval revenue: Limited; reliance on licensing or partnership deals.
• Post-approval: Revenue growth driven by sales and potential licensing agreements.
• Long-term profitability: Dependent on market adoption, pricing, reimbursement, and competition.

Pfizer's acquisition of Eidos for $500 million in 2022 provided a strategic platform, with additional milestone payments linked to regulatory approval and sales targets.

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Risks and Uncertainties

• Regulatory delays or setbacks: Regulatory review timelines could extend beyond expectations.
• Market adoption: Physician acceptance and patient awareness significantly influence sales.
• Pricing and reimbursement: Payers' willingness to reimburse at the projected rates remains uncertain.
• Competitive developments: Future therapies or improved formulations could impact market share.

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Key Takeaways

• Acoramidis is in late-stage development, with FDA submission completed and approval anticipated in early 2024.
• The global ATTR amyloidosis market is underserved, offering lucrative growth if the drug reaches broad adoption.
• Competition from tafamidis sets a high standard; acoramidis’s superior stabilization could confine it to a niche unless it demonstrates clear clinical advantages.
• Revenue projections indicate significant growth, potentially reaching over $1.5 billion annually within three years post-launch.
• Patent life and pricing strategies will shape long-term profitability; competition could emerge in the late 2030s.

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FAQs

1. What makes acoramidis different from existing treatments like tafamidis?
Acoramidis has higher potency in stabilizing transthyretin and displays better pharmacokinetics, which may translate into improved efficacy, especially in severe disease stages.

2. What are the key hurdles for acoramidis’s market entry?
Regulatory approval depends on NDA review outcomes; physician and patient acceptance, reimbursement negotiations, and competition also influence market penetration.

3. How large is the current market for ATTR amyloidosis treatments?
Approximately 50,000 to 70,000 patients globally, with 40,000 cases of ATTR-CM, but diagnosis rates are low, limiting market size.

4. What is the competitive strategy for acoramidis?
Position as a superior and potentially more effective TTR stabilizer, emphasizing clinical trial data and targeting earlier-stage patients.

5. How do patent protections impact long-term sales?
Patents extend into the late 2030s, providing exclusivity and pricing leverage, but eventual patent expiry may prompt generic competition.

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References

[1] Eidos Therapeutics. "Acoramidis NDA Submission." November 2022.
[2] Global ATTR Amyloidosis Market Report, 2022.
[3] Pfizer Press Release. "Acquisition of Eidos Therapeutics," 2022.
[4] FDA. "New Drug Application Review Timeline," 2023.
[5] Market Analysis for Amyloid Drugs, 2023.