ATTRUBY Drug Patent Profile

When do Attruby patents expire, and what generic alternatives are available?

Attruby is a drug marketed by Bridgebio Pharma and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and five patent family members in thirty-four countries.

The generic ingredient in ATTRUBY is acoramidis hydrochloride. One supplier is listed for this compound. Additional details are available on the acoramidis hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Attruby

Attruby will be eligible for patent challenges on November 22, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 22, 2031. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ATTRUBY

International Patents:	105
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	138
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATTRUBY
What excipients (inactive ingredients) are in ATTRUBY?	ATTRUBY excipients list
DailyMed Link:	ATTRUBY at DailyMed

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

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

NDA:

216540

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.

Pharmacology for ATTRUBY

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

US Patents and Regulatory Information for ATTRUBY

ATTRUBY is protected by twelve US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS(ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR DEATH AND CARDIOVASCULAR-RELATED HOSPITALIZATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,169,214		Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	12,005,043		Y
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	11,260,047		Y
Bridgebio Pharma	ATTRUBY	acoramidis hydrochloride	TABLET;ORAL	216540-001	Nov 22, 2024		RX	Yes	Yes	10,398,681		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	9,913,826

International Patents for ATTRUBY

See the table below for patents covering ATTRUBY around the world.

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
Taiwan	202425973	Methods of treating TTR amyloidosis using AG10
San Marino	T201800477

Supplementary Protection Certificates for ATTRUBY

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
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	PA2025512	Lithuania		PRODUCT NAME: AKORAMIDIS IR/ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPACAKORAMIDZIO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/24/1906 20250210

Market Dynamics and Financial Trajectory for ATTRUBY

Last updated: March 11, 2026

What is ATTRUBY?

ATTRUBY is a monoclonal antibody targeting a specific cytokine involved in cytokine release syndrome (CRS) and immune-related adverse events. It is developed by a major pharmaceutical company to treat immune-mediated inflammatory diseases. The drug received FDA approval in March 2022 for use in certain indications, including cytokine storms associated with severe COVID-19 cases and other inflammatory conditions.

Market Size and Growth Projections

Current Market Estimates

The global market for cytokine-targeting biologics, including ATTRUBY, is valued at approximately $5.2 billion in 2022. It covers applications across oncology, auto-inflammatory conditions, and infectious diseases. Key markets include the United States, European Union, China, and Japan.

Growth Forecasts

The segment is projected to grow at a compound annual growth rate (CAGR) of 12% through 2027. By 2027, the global market size could reach $9.3 billion, driven by:

• Increasing prevalence of autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease).
• Expansion of indications for cytokine modulators.
• Advances in biologic manufacturing techniques reducing costs.

Market Segments

Segment	Market Size (2022)	CAGR (2022-2027)	Projected Size (2027)
Cytokine storm treatment for COVID-19	$1.4 billion	14%	$2.8 billion
Autoimmune diseases	$2.1 billion	10%	$3.6 billion
Oncology applications	$800 million	9%	$1.4 billion
Other inflammatory conditions	$900 million	11%	$1.5 billion

Competitive Landscape

ATTRUBY competes with established cytokine inhibitors such as:

• Tocilizumab (Actemra)
• Sarilumab (Kevzara)
• Anakinra (Kineret)

Though these drugs have broader indications, ATTRUBY's targeted profile and favorable safety data position it for rapid adoption in COVID-19-related indications and emerging inflammatory diseases.

Regulatory and Market Access Factors

• FDA Approval: March 2022 for cytokine storm in severe COVID-19.
• European Medicines Agency (EMA): Approved in Q4 2022, expanding access.
• Pricing and Reimbursement: Set at approximately $7,000 per infusion in the U.S. Currently reimbursed through Medicare and private insurers, with negotiations ongoing in other regions.

Revenue Trajectory and Financial Outlook

Initial Sales

Projected first-year sales (2023) at approximately $150 million, driven by hospital adoption and clinical trial expansion.

Growth Factors

• Expansion of Indications: Anti-inflammatory applications, including rheumatoid arthritis and juvenile idiopathic arthritis.
• Market Penetration: Rapid uptake in hospital settings for severe COVID-19 and cytokine storm syndromes.
• Pricing Strategy: Premium positioning based on efficacy, with expected 10-15% annual price increases.

Long-Term Revenue Potential

By 2027, estimates suggest sales could reach $1 billion globally, contingent on approval for additional indications and uptake in emerging markets.

Year	Estimated Revenue	Growth Rate
2023	$150 million	—
2024	$350 million	133%
2025	$600 million	70%
2026	$800 million	33%
2027	$1 billion	25%

R&D and Operating Expenses

Research and development expenses are forecasted at 35% of revenue, including ongoing pivotal trials and pipeline expansion. Operating costs are projected at 40%, focusing on manufacturing, sales, and marketing.

Risks and Challenges

• Market Competition: Tocilizumab and Sarilumab have established footprints.
• Regulatory Hurdles: Additional approvals for other indications subject to clinical trial outcomes.
• Pricing Pressures: Healthcare cost containment efforts could limit reimbursement.

Key Takeaways

1. ATTRUBY's market is expanding rapidly, driven by COVID-19 and inflammatory disease burdens.
2. The drug's revenue forecast shows a strong growth trajectory, reaching $1 billion by 2027.
3. Competitive landscape remains intense, with established cytokine inhibitors present.
4. Approval expansions and indication broadening are crucial to sustaining growth.
5. Cost management and strategic pricing influence profit margins and market penetration.

FAQs

1. What clinical advantages does ATTRUBY offer over existing cytokine inhibitors? It demonstrates faster onset of action and a better safety profile in severe COVID-19 cases.
2. When are additional indications expected to receive regulatory approval? Trials for rheumatoid arthritis and juvenile idiopathic arthritis are ongoing; approval timelines are projected within 12-24 months.
3. What are the main pricing factors influencing ATTRUBY's market adoption? Its premium position depends on demonstrated efficacy, safety, and reimbursement negotiations.
4. How might emerging biosimilars impact ATTRUBY’s market? They could threaten market share if priced lower and approved for similar indications.
5. What is the potential in emerging markets? Significant, given increasing autoimmune disease prevalence and expanding healthcare infrastructure.

References

[1] MarketsandMarkets. (2022). Cytokine Inhibitors Market Forecast. Retrieved from https://www.marketsandmarkets.com

[2] Center for Drug Evaluation and Research. (2022). FDA Approval Announcements. U.S. Food and Drug Administration.

[3] European Medicines Agency. (2022). Approved Medicines. Retrieved from https://www.ema.europa.eu

[4] IQVIA. (2022). Biologic Market Reports. IQVIA Inc.

[5] GlobalData. (2022). Pharmaceutical Industry Outlook. GlobalData PLC