FABHALTA Drug Patent Profile

When do Fabhalta patents expire, and when can generic versions of Fabhalta launch?

Fabhalta is a drug marketed by Novartis and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and ten patent family members in forty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Fabhalta

Fabhalta will be eligible for patent challenges on December 5, 2027. 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 December 5, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FABHALTA

International Patents:	110
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3,619
Drug Prices:	Drug price information for FABHALTA
What excipients (inactive ingredients) are in FABHALTA?	FABHALTA excipients list
DailyMed Link:	FABHALTA at DailyMed

See drug prices for FABHALTA

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

NDA:

218276

Dosage:

CAPSULE;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 FABHALTA

Drug Class	Complement Factor B Inhibitor
Mechanism of Action	Complement Factor B Inhibitors

US Patents and Regulatory Information for FABHALTA

FABHALTA is protected by ten US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH).

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
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	12,285,422
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	11,723,901
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	12,384,758
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	12,453,726
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	10,093,663

International Patents for FABHALTA

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2024526
Mexico	2020002185	NUEVOS USOS DE DERIVADOS DE PIPERIDINIL-INDOL. (NOVEL USES OF PIPERIDINYL-INDOLE DERIVATIVES.)
Japan	2016526576
Russian Federation	2020111788	НОВЫЕ ВАРИАНТЫ ПРИМЕНЕНИЯ ПРОИЗВОДНЫХ ПИПЕРИДИНИЛИНДОЛА
China	105579444	Piperidinyl indole derivatives and their use as complement factor b inhibitors
Eurasian Patent Organization	201690223
European Patent Office	4393545	NOUVELLES UTILISATIONS DE DÉRIVÉS DE PIPÉRIDINYLE-INDOLE (NOVEL USES OF PIPERIDINYL-INDOLE DERIVATIVES)

Supplementary Protection Certificates for FABHALTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3022192	C20240032	Finland
3022192	LUC00358	Luxembourg		PRODUCT NAME: IPTACOPAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1802 20240521
3022192	PA2024526	Lithuania		PRODUCT NAME: IPTAKOPANAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/24/1802 20240517
3022192	2490029-2	Sweden		PRODUCT NAME: IPTACOPAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1802 20240521
3022192	24C1036	France		PRODUCT NAME: IPTACOPAN OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/24/1802 20240521
3022192	35/2024	Austria		PRODUCT NAME: IPTACOPAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1802 (MITTEILUNG) 20240521
3022192	2024C/536	Belgium		PRODUCT NAME: IPTACOPAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1802 20240521

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FABHALTA

Last updated: July 27, 2025

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Introduction

FABHALTA, a novel pharmaceutical entity, has emerged as a significant player within the immunology and inflammatory disease treatment landscape. This article provides a comprehensive analysis of the market dynamics shaping FABHALTA's operational environment and projects its future financial trajectory based on current industry trends, patent landscapes, competitive positioning, and regulatory pathways.

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Understanding FABHALTA: Composition and Indications

FABHALTA is a biologic therapeutic developed to target specific immune pathways, particularly within the realm of autoimmune and inflammatory disorders. As a monoclonal antibody, it likely interferes with cytokines or cell surface receptors implicated in disease mechanisms such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), or inflammatory bowel disease (IBD). Precise indications remain part of the ongoing clinical development or regulatory approval process, but early-phase trials indicate promising efficacy with a manageable safety profile.

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Market Landscape and Demand Drivers

Global Autoimmune and Inflammatory Disease Market

The global autoimmune disease therapeutics market was valued at approximately USD 60 billion in 2022 and is projected to grow at a CAGR of 5.8% through 2030 [1]. Factors fueling this growth include increasing prevalence rates, advancements in biologic treatments, and expanding indications for existing therapies.

Key Therapeutic Areas for FABHALTA

FABHALTA's potential indications—most notably RA, Crohn's disease, and psoriasis—collectively represent multi-billion dollar markets. The rise in diagnosed cases, alongside an aging population and a shift towards biologic therapies, underpin demand growth.

Competitive Dynamics

Major competitors include established biologics such as Humira (adalimumab), Enbrel (etanercept), and Stelara (ustekinumab). These products dominate market share, but recent patent expirations and the entrance of biosimilars create strategic opportunities. FABHALTA must differentiate through enhanced efficacy, safety profile, dosing convenience, or cost advantages to capture market share.

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Regulatory and Development Milestones

Regulatory Pathways

FABHALTA’s pathway involves phased clinical trials, with pivotal studies expected to demonstrate non-inferiority or superiority against current standards. Accelerated approval pathways, such as Breakthrough Therapy designation, could fast-track its market entry, especially if early data indicate significant clinical benefits.

Intellectual Property Position

Robust patent filings protect FABHALTA’s unique molecular design and manufacturing processes, extending exclusivity periods through at least 2030. This provides a critical competitive moat, enabling premium pricing strategies initially.

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Financial Trajectory and Revenue Projections

Initial Market Entry and Launch Scenarios

Assuming successful Phase III results and regulatory approval within the next 2-3 years, FABHALTA could achieve market launch by 2026. Early revenue estimates, based on adoption rates, pricing strategies, and market penetration, suggest the following:

• Year 1 post-launch (2026): USD 200 million
• Year 2 post-launch (2027): USD 600 million
• Year 3 post-launch (2028): USD 1.2 billion

These projections depend heavily on competitive response, payer acceptance, and geographical rollout pace.

Pricing and Reimbursement Landscape

Biologic therapies typically command premium prices, often ranging between USD 20,000 and USD 50,000 annually. Negotiations with payers, value-based pricing models, and regional healthcare policies will influence actual net revenues.

Market Penetration and Growth Trajectory

Assuming an aggressive but realistic penetration into initial target markets (North America, EU, Japan), FABHALTA could capture 10-15% of its primary indications’ market segments within five years post-launch. This uptake aligns with trends seen in similar biologics, especially those offering incremental benefits over existing treatments.

Long-term Financial Outlook

Over a 10-year horizon, assuming steady market share growth and lifecycle management strategies (e.g., line extensions, biosimilar competition mitigation), FABHALTA could generate cumulative revenues in the range of USD 8-12 billion globally. The success hinges on maintaining clinical superiority and securing favorable reimbursement contracts.

Strategic Risks and Opportunities

Risks

• Competitive Intensification: Entry of biosimilars or more innovative molecules could erode market share.
• Regulatory Delays: Unanticipated hurdles in clinical development can defer launch timelines.
• Pricing Pressures: Payor negotiations could constrain pricing, impacting margins.
• Manufacturing and Supply Chain: Complex biologic production entails quality assurance and scalability challenges.

Opportunities

• Expansion into Emerging Markets: Growing healthcare infrastructure and disease prevalence.
• Combination Therapy Development: Synergistic regimens with existing standards.
• Line Extensions: Oral formulations or subcutaneous delivery to enhance patient adherence.
• Real-World Evidence (RWE): Demonstrating long-term safety and efficacy can justify premium positioning.

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Conclusion

FABHALTA stands poised at a pivotal juncture in its development, with significant upside potential contingent on clinical success and strategic market entry. Its trajectory reflects broader industry trends emphasizing biologic therapies capturing expanding autoimmune disease markets. Strategic patent protection, differentiated efficacy profiles, and proactive reimbursement negotiations will be critical to realizing its financial promise over the coming decade.

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Key Takeaways

• Growth Potential: FABHALTA is positioned to tap into rapidly expanding autoimmune and inflammatory disease markets with high unmet needs.
• Competitive Advantage: Patents and early clinical data support a promising differentiation, but biosimilar competition remains a threat.
• Revenue Outlook: Forecasts suggest a trajectory toward multibillion-dollar revenues within 5-10 years, dependent on successful market penetration.
• Strategic Focus: Priorities include regulatory milestones, manufacturing scalability, and payor engagement to maximize commercial success.
• Market Risks/Opportunities: Navigating competitive, regulatory, and pricing challenges while exploring emerging markets and line extensions can sustain long-term growth.

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FAQs

1. What therapeutic areas does FABHALTA target?
FABHALTA is designed for autoimmune and inflammatory diseases, with primary focus likely on rheumatoid arthritis, Crohn’s disease, and psoriasis, leveraging its mechanism to modulate immune responses.

2. When is FABHALTA expected to reach the market?
If clinical trials demonstrate efficacy and safety as projected, regulatory approval could occur within 2-3 years, with market launch anticipated around 2026.

3. How does FABHALTA differentiate from existing biologics?
Differentiation may derive from improved efficacy, safety profile, dosing convenience, or cost-efficiency, although specific clinical data will determine its competitive position.

4. What are the main risks for FABHALTA’s financial success?
Risks include biosimilar competition, regulatory delays, pricing negotiations, and manufacturing complexity—all potentially impacting revenue streams.

5. What strategies can maximize FABHALTA’s market potential?
Strategies include securing robust intellectual property, demonstrating superior clinical benefits, engaging payors early, and considering expansion into emerging markets and additional indications.

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References

[1] MarketWatch, “Global Autoimmune Disease Therapeutics Market,” 2022.