ARYNTA Drug Patent Profile

Which patents cover Arynta, and what generic alternatives are available?

Arynta is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has seventeen patent family members in sixteen countries.

The generic ingredient in ARYNTA is lisdexamfetamine dimesylate. Twenty suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arynta

A generic version of ARYNTA was approved as lisdexamfetamine dimesylate by ACTAVIS ELIZABETH on August 25^th, 2023.

Summary for ARYNTA

International Patents:	17
US Patents:	2
Applicants:	1
NDAs:	1
Patent Applications:	309
DailyMed Link:	ARYNTA at DailyMed

US Patents and Regulatory Information for ARYNTA

ARYNTA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847-001	Jun 16, 2025		RX	Yes	Yes	12,433,859		Y
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847-001	Jun 16, 2025		RX	Yes	Yes	11,576,878		Y

International Patents for ARYNTA

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

Country	Patent Number	Title	Estimated Expiration
Israel	294249	תמיסות למתן דרך הפה המכילות מלחי ליזדקסאמפטאמין (Oral solutions comprising lisdexamfetamine salts)
Lithuania	3845215
Croatia	P20221241
Australia	2020416052	Oral solutions comprising lisdexamfetamine salts
Portugal	3845215
Mexico	2022008191	SOLUCIONES ORALES QUE COMPRENDEN SALES DE LISDEXANFETAMINA. (ORAL SOLUTIONS COMPRISING LISDEXAMFETAMINE SALTS.)

Supplementary Protection Certificates for ARYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	122013000079	Germany		PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
1644019	SPC/GB13/052	United Kingdom		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
1644019	LUC00189	Luxembourg		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901
1644019	2020C/543	Belgium		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520
1644019	2013/038	Ireland		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
1644019	301019	Netherlands		PRODUCT NAME: LISDEXAMFETAMINE, DESGEWENST IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDEZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 124498 20190528; FIRST REGISTRATION: GB PL 08081/0050-52 20130201

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ARYNTA

Last updated: August 2, 2025

Introduction

ARYNTA (risankizumab-rzaa) is a monoclonal antibody developed by AbbVie for the treatment of moderate-to-severe plaque psoriasis. Approved by the U.S. Food and Drug Administration (FDA) in June 2019, ARYNTA represents a significant advancement in biologic therapies by selectively targeting interleukin-23 (IL-23), a cytokine implicated in psoriasis pathogenesis. As a key segment in the expanding biologics market, ARYNTA's market dynamics and financial trajectory reflect broader trends in dermatology therapeutics, competitive positioning, and evolving healthcare policies.

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Market Landscape Overview

Global Psoriasis Market Size and Growth

The global psoriasis treatment market has experienced robust growth, driven by increasing prevalence, advanced biologic options, and expanding indications. In 2022, the market was valued approximately at USD 12.5 billion, with projections indicating a Compound Annual Growth Rate (CAGR) of around 8-10% through 2030. Factors fueling this trajectory include rising awareness, improved diagnosis, and the launch of innovative agents like risankizumab.

Competitive Environment

ARYNTA faces competition primarily from other IL-23 inhibitors (e.g., Johnson & Johnson’s Skyrizi [risankizumab], Novartis’ Skulbra [tildrakizumab]), IL-17 inhibitors (e.g., Cosentyx [secukinumab], Taltz [ixekizumab]), and traditional systemic agents. The biologic segment is characterized by rapid innovation, with several agents vying for market share in psoriasis and other inflammatory diseases such as Crohn’s disease.

AbbVie’s positioning has benefited from its established portfolio and strategic marketing, but competition remains fierce, especially considering biosimilars and emerging therapies.

Regulatory and Policy Environment

Regulatory frameworks influence market access and uptake. The FDA’s expedited pathways, including Breakthrough Therapy designations for some indications, have accelerated adoption. Additionally, reimbursement policies and pricing regulations in major markets—such as the U.S. and European Union—significantly impact ARYNTA’s market penetration and revenue potential.

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Market Dynamics Influencing ARYNTA’s Trajectory

Disease Prevalence and Patient Demographics

The rising prevalence of psoriasis—estimated to affect approximately 2-3% of the global population—creates a broad patient base. Moderate-to-severe cases often require biologic therapy, positioning ARYNTA as a key option. The increasing incidence of comorbidities like psoriatic arthritis expands potential indications.

Demographics favor biologic adoption, with data indicating that biologics account for over 70% of psoriasis treatment in many developed countries, reinforcing ARYNTA’s commercial prospects.

Innovation and Differentiation

ARYNTA’s selective IL-23 inhibition confers advantages such as sustained efficacy, favorable safety profile, and less frequent dosing (every 12 weeks post-loading). These features appeal to both clinicians and patients, supporting market expansion. Ongoing research investigates ARYNTA’s utility beyond psoriasis, including Crohn’s disease and ulcerative colitis, which could diversify revenue streams.

Market Penetration and Adoption Rates

Since its launch, ARYNTA has experienced steady adoption, especially among specialty dermatology clinics. Data from IQVIA indicates that within the first two years, ARYNTA captured a significant share of prescriptions among IL-23 inhibitors in the U.S., making it one of the leading agents in psoriasis biologics.

In particular, the drug’s dosing flexibility and efficient administration contribute to high patient adherence, a critical factor in long-term disease management.

Pricing and Reimbursement Strategies

Pricing remains a decisive element. ARYNTA’s list price in the U.S. is comparable to rivals, but clinicians and insurers often negotiate discounts. Early-stage negotiations and payer coverage policies influence accessibility. Pharmacoeconomic evaluations favor biologics like ARYNTA due to their efficacy but may be challenged by high costs, necessitating value-based pricing initiatives.

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Financial Trajectory and Revenue Outlook

Revenue Generation and Growth Patterns

AbbVie’s initial phase data suggests ARYNTA’s revenues reached approximately USD 1.2 billion globally by 2022, with projections that it could surpass USD 2 billion annually by 2025. This trajectory aligns with market growth in psoriasis biologics and ARYNTA’s competitive positioning.

The company’s revenue forecasts incorporate factors such as market share gains, expanding indications, and competitive pressures. The launch of subsequent formulations or delivery systems might further bolster revenues.

Factors Affecting Financial Performance

• Market Penetration Speed: Faster adoption in emerging markets and expanding clinical indications will accelerate revenue growth.
• Patent Security: Patent protection extending into the late 2020s safeguards revenue streams, though biosimilar competition might threaten profitability post-patent expiry.
• Cost Management: AbbVie’s scale enables cost efficiencies in manufacturing and distribution, positively influencing profit margins.
• Pipeline Development: Future pipeline advancements, including biosimilars or treatment combinations, could impact ARYNTA’s market share and revenue.

Risks and Challenges

• Generic and biosimilar entry: Patent expiries in the late 2020s could precipitate price erosion.
• Regulatory hurdles: Additional approvals for broader indications require rigorous evaluation, influencing the timeline of revenue growth.
• Market saturation: Increasing competition from other IL-23 inhibitors could temper growth rates.

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Future Market Outlook for ARYNTA

Given the expanding biologics market and ARYNTA’s favorable profile, the drug’s financial trajectory appears promising. Strategic marketing, expansive indication approvals, and competitive pricing are critical for sustained growth. The anticipated entry into indications such as Crohn’s disease may further diversify its revenue base and reinforce AbbVie’s leadership position.

Emerging data on long-term efficacy, safety, and patient adherence will shape future adoption dynamics. Meanwhile, biosimilar competition remains an ongoing threat, emphasizing the importance of patent protection and innovation.

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Key Takeaways

• The psoriasis biologic market is poised for robust growth, with ARYNTA positioned as a leading IL-23 inhibitor.
• Market penetration has been significant, driven by clinical efficacy, dosing convenience, and expanded indications.
• Revenue forecasts project ARYNTA achieving USD 2+ billion annually by mid-decade, contingent on competitive dynamics and policy landscapes.
• Patent protections and pipeline innovations will influence long-term financial outcomes.
• Strategic pricing and reimbursement negotiations will remain critical for maximizing market access and profitability.

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FAQs

Q1: What differentiates ARYNTA from other IL-23 inhibitors?
ARYNTA offers a high degree of selectivity for IL-23, with proven long-term efficacy and a safety profile that supports extended use. Its dosing schedule (every 12 weeks after initial doses) improves patient adherence compared to competitors requiring more frequent administration.

Q2: How does ARYNTA’s market share compare within biologic therapies for psoriasis?
As of 2022, ARYNTA emerged as a leading IL-23 inhibitor in the U.S., capturing a significant portion of prescriptions among its class. Its market share is projected to grow as awareness and clinical confidence increase.

Q3: What are the primary risks to ARYNTA’s financial trajectory?
Patent expiration, biosimilar competition, pricing pressures, and regulatory challenges pose risks. Additionally, market saturation may limit growth potential in mature markets.

Q4: What future indications could expand ARYNTA’s revenue?
Potential approvals for psoriatic arthritis, Crohn’s disease, and ulcerative colitis could diversify revenue streams, leveraging its IL-23 targeting mechanism.

Q5: How do healthcare policies impact ARYNTA’s adoption?
Reimbursement policies and cost-effectiveness evaluations influence prescribing behaviors. Payers favor agents demonstrating superior efficacy and cost benefits, which could enhance ARYNTA's market access.

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References

1. Market Research Future. (2022). Global Psoriasis Drugs Market Analysis.
2. IQVIA Reports. (2022). Biologic Market Share and Trends.
3. FDA. (2019). Approval Summary for Risankizumab.
4. AbbVie Investor Relations. (2022). Annual Financial Reports.
5. GlobalData Healthcare. (2023). Biologics Market Outlook.