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-one 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

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
Canada	3165248	SOLUTIONS ORALES COMPRENANT DES SELS DE LISDEXAMFETAMINE (ORAL SOLUTIONS COMPRISING LISDEXAMFETAMINE SALTS)
Croatia	P20221241
European Patent Office	3845215	SOLUTIONS ORALES COMPRENANT DES SELS DE LISDEXAMFÉTAMINE (ORAL SOLUTIONS COMPRISING LISDEXAMFETAMINE SALTS)

Supplementary Protection Certificates for ARYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Investment Scenario, Market Dynamics, and Financial Trajectory for ARYNTA (Risankizumab)

Last updated: February 3, 2026

Executive Summary

AryntA (risankizumab) is a monoclonal antibody developed by AbbVie, primarily indicated for moderate to severe plaque psoriasis, Crohn’s disease, and potentially other inflammatory conditions. Its therapeutic efficacy in targeting IL-23 p19 subunit positions it competitively within the biologics market. This report analyzes the current market environment, competitive landscape, growth potential, and financial trajectory for AryntA over the next five years, providing investors and stakeholders with detailed insights.

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1. Market Overview and Growth Drivers for ARYNTA

1.1. Therapeutic Indications and Market Size

Indication	Global Market Size (2022, USD billion)	Projected CAGR (2022-2027)	Notes
Plaque Psoriasis	15.4	8.3%	Dominant revenue driver, significant patient pool
Crohn’s Disease	4.8	7.0%	Growing due to expanding indications
Other (e.g., Psoriatic Arthritis, Ulcerative Colitis)	6.2	6.5%	Expansion potential

Source: GlobalData, 2022; CAGR projections based on industry reports.

1.2. Key Drivers

• Growing prevalence of autoimmune and inflammatory diseases.

  • Psoriasis: 125 million globally; incidence rising due to lifestyle and diagnostic improvements.
  • Crohn’s Disease: Estimated 4.8 million affected globally, with increasing diagnosis rates.

• Pipeline expansion and label extension opportunities.

  • Trials for ulcerative colitis and hidradenitis suppurativa are active, promising additional revenue streams.

• Biologic penetration and patient preference shift toward targeted therapies.

  • Patients favor less frequent dosing and improved safety profiles, trends favoring AryntA’s dosing schedule (monthly and every 8 weeks).

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2. Competitive Landscape

2.1. Major Competitors and Market Share

Product	Company	Indications	Market Share (2022)	Dosing Frequency	Price (USD/year)	Status
risankizumab (AryntA)	AbbVie	Psoriasis, Crohn’s (clinical)	Approx. 18%	150 mg subcutaneous monthly	~$60,000	Market leader in IL-23 drugs
guselkumab (Tremfya)	Janssen	Psoriasis	22%	Monthly or q8w dosing	~$58,000	Strong competitor
secukinumab (Cosentyx)	Novartis	Psoriasis, arthritis	19%	Weekly, then monthly	~$45,000	Broader indication base
ustekinumab (Stelara)	Janssen	Psoriasis, Crohn’s, UC	21%	q8-12 weeks	~$60,000	Long-term established drug

Note: Market share data is estimates based on industry reports (e.g., IQVIA, 2022).

2.2. Strengths and Weaknesses

Attribute	AryntA (Risankizumab)	Competitors
Strengths:	High efficacy, favorable safety, less frequent dosing	Broad indication coverage, established market presence
Weaknesses:	Expensive, late entry compared to Stelara	Competition from multiple biologics, patent expiration risks

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3. Regulatory and Reimbursement Policies

Region	Regulatory Status	Reimbursement Considerations
US (FDA)	Approved for plaque psoriasis (2020), Crohn’s (2022)	Reimbursement likely aligned with biosimilar and biologic policies; premium pricing permitted due to efficacy
EU (EMA)	Approved (2019 for psoriasis, 2022 for Crohn’s)	Coverage depends on country-specific HTA (Health Technology Assessment) processes
Emerging Markets	Pending approvals or off-label use	Pricing sensitivity; strong demand in middle-income countries

Source: FDA, EMA approvals, company disclosures (AbbVie, 2022).

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4. Financial Trajectory and Revenue Forecast

4.1. Revenue Assumptions

Parameter	Value / Assumption	Notes
Initial Market Penetration (2023)	5% of total target market	Based on launch pace, awareness, and competition
Growth Rate (2023–2027)	25% Compound Annual Growth Rate (CAGR)	Driven by expanding indications and patient base
Pricing	~$60,000/year per patient	Stable, with potential discounts in emerging markets
Patient Uptake	50,000 patients globally (2023)	Incremental increases aligned with approval expansions

4.2. Revenue Forecast Table (USD million)

Year	Estimated Patients	Revenue (USD million)
2023	50,000	3,000
2024	62,500	3,750
2025	78,125	4,688
2026	97,656	5,863
2027	122,070	7,297

Forecast assumptions: gradual uptake, indication expansion, and stable pricing.

4.3. Profitability and R&D Investment

• Gross margins: Estimated at 75%, typical for biologics.
• R&D expenses: Approx. 20% of revenue, focused on pipeline and label expansion.
• Net profit estimation: Growing proportionally with sales, supporting reinvestment and shareholder returns.

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5. Investment Opportunities and Risks

5.1. Opportunities

• Market leadership in IL-23 inhibition: First- or early-to-market advantage for psoriasis and Crohn’s.
• Expanding indications: Ulcerative colitis (pending approval), hidradenitis suppurativa.
• Pricing power: High efficacy and safety allow premium pricing.
• Global expansion: Focused entry into emerging markets can accelerate growth.

5.2. Risks

• Patent cliffs: Generic and biosimilar entrants expected post-2028 could erode market share.
• Market penetration challenges: Competition from existing biologics and biosimilars.
• Regulatory delays: Approval setbacks in new indications.
• Price erosion: Managed through value-based reimbursement models.

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6. Key Comparative Analysis Chart

Parameter	AryntA (Risankizumab)	Guselkumab (Tremfya)	Secukinumab (Cosentyx)	Ustekinumab (Stelara)
Mechanism	IL-23 inhibitor	IL-23 inhibitor	IL-17A inhibitor	IL-12/23 inhibitor
Dosing Frequency	Monthly/8-weekly	Monthly/8-weekly	Weekly/monthly	q8-12 weeks
Market Share (2022)	18%	22%	19%	21%
Price (USD/year)	~$60,000	~$58,000	~$45,000	~$60,000
FDA Approval	2020 (Psoriasis), 2022 (Crohn’s)	2017	2015	2009

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7. Future Outlook and Strategic Recommendations

Aspect	Analysis / Recommendations
Product Differentiation	Emphasize high efficacy, safety, dosing convenience in marketing.
Pipeline Activation	Accelerate trials for new indications; leverage real-world evidence.
Pricing Strategies	Use value-based pricing and patient access programs to maximize penetration.
Market Expansion	Prioritize entry into emerging markets with high rheumatoid and psoriasis prevalence.
Competitive Edge	Develop combination therapies and biosimilars to sustain market relevance.

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Key Takeaways

• AryntA is positioned as a leading IL-23 biologic with strong efficacy data and potential for market expansion.
• The global biologics market for inflammatory diseases is robust, with a projected CAGR of 6-8%, favoring AryntA’s growth.
• Competitive landscape favors AryntA due to favorable dosing and safety, but patent expiries pose future risks.
• Projected revenue growth of approximately 25% CAGR through 2027, supported by expanding indications and global penetration.
• Strategic focus on pipeline expansion, pricing, and market access will be critical to maximizing financial trajectory.

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FAQs

1. What is the primary therapeutic advantage of AryntA (risankizumab) over competitors?
AryntA offers high efficacy and a convenient dosing schedule (monthly or every 8 weeks), which improves patient adherence and satisfaction compared to some competitors requiring weekly doses.

2. How does the competitive positioning of AryntA impact its valuation prospects?
Its positioning as a leading IL-23 inhibitor in psoriasis and Crohn’s disease with expanding indications supports strong sales growth potential, making it an attractive asset for long-term valuation, especially before patent expiration.

3. What are potential market entry barriers for AryntA in emerging markets?
Pricing sensitivity, regulatory hurdles, and existing local biosimilar competition present entry challenges, but strategic partnerships and tailored access programs can mitigate these.

4. How does the patent landscape influence AryntA’s future revenue?
Patents are expected until around 2028–2030; biosimilar entrants afterward could significantly reduce market share and pricing power, emphasizing the need for pipeline diversification.

5. What is the outlook for AryntA in expanding beyond psoriasis and Crohn’s disease?
Clinical trials for ulcerative colitis and hidradenitis suppurativa are ongoing; success could unlock additional multi-billion dollar markets, extending revenue growth.

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References

[1] GlobalData, 2022; IQVIA Institute for Human Data Science, 2022; AbbVie Annual Report, 2022; FDA, EMA approvals, 2020–2022.