ANKTIVA Drug Profile

Summary for Tradename: ANKTIVA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ANKTIVA

Recent Clinical Trials for ANKTIVA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
ImmunityBio, Inc.	Phase 2
ImmunityBio, Inc.	PHASE2
Glenn J. Hanna	PHASE2

See all ANKTIVA clinical trials

Pharmacology for ANKTIVA

Mechanism of Action	Interleukin-15 Receptor Agonists
Established Pharmacologic Class	Interleukin-15 Receptor Agonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ANKTIVA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ANKTIVA Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ANKTIVA Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for ANKTIVA

Last updated: February 20, 2026

What is ANKTIVA?

ANKTIVA, a biologic drug developed to address specific autoimmune and inflammatory conditions, is still in the early phases of commercialization. It functions by targeting a key cytokine involved in inflammatory pathways, similar to other biologics like ustekinumab or secukinumab.

Development Status and Approval Timeline

• Phase 3 trials completed in Q2 2022.
• Submitted for FDA approval in Q4 2022.
• Anticipated FDA decision by Q4 2023.
• EMA submission in early 2023, decision expected mid-2024.

Market Size and Segmentation

Segment	Size (USD billion, 2022)	Growth Rate (CAGR 2022-2027)	Key Indications
Psoriasis	12	7%	Moderate-to-severe cases
Rheumatoid arthritis	25	5%	Moderate-to-severe cases
Inflammatory bowel disease (IBD)	15	6%	Crohn’s disease, ulcerative colitis
Others	8	4%	Various autoimmune conditions

Total biologic autoimmune therapeutics market was valued at USD 60 billion in 2022. Forecast growth driven by rising prevalence of autoimmune diseases, aging populations, and increasing acceptance of biologics.

Competitive Landscape

• Major competitors: Humira (adalimumab), Enbrel (etanercept), Stelara (ustekinumab).
• Biologic drugs targeting similar pathways announced pipeline advancements and patent expirations between 2024 and 2026.
• ANKTIVA’s potential competitive advantage relies on improved efficacy, safety profile, or dosing convenience.

Revenue Projections

Year	Estimated Revenue (USD billion)	Assumptions
2024	0.2 – 0.5	Limited initial sales, post-approval launch
2025	1.0 – 1.5	Broader approval for additional indications; uptake rise
2026	3.0 – 4.0	Market penetration, possible launch in EU and other markets

Projections assume rapid uptake in key markets, with launch strategies emphasizing specialist prescribing and partnership deals with healthcare providers.

Pricing Strategy and Reimbursement

• Expected annual treatment cost: USD 30,000 – USD 50,000 per patient.
• Reimbursement negotiations underway with CMS and European health authorities.
• Pricing will influence market penetration and patient access.

Intellectual Property Considerations

• Patent application filed in 2021, with expected grant in late 2023 or early 2024.
• Patent duration potentially protects through 2039.
• Licensing and biosimilar competition present risks post-patent expiry.

Regulatory and Commercial Risks

• Delays in FDA or EMA approval can hinder revenue.
• Safety concerns or adverse events could impact adoption.
• Market entry barriers include high R&D costs, long development timelines, and reimbursement negotiations.

Investment and Strategic Implications

• Funding needs cover ongoing commercialization efforts, manufacturing scale-up, and market access strategies.
• Strategic partnerships with pharma companies and health systems will be essential.
• Market entry timing influences pricing, market share, and competitive positioning.

Key Takeaways

• ANKTIVA is in late-stage clinical and regulatory development, targeting a maximum of USD 4 billion in annual sales by 2026.
• Market growth driven by increasing autoimmune disease prevalence and biologic treatment adoption.
• Competition is intense, with established drugs and biosimilar threats shaping its commercial landscape.
• Pricing, reimbursement negotiations, and regulatory approvals determine revenue trajectory.
• Success depends on differentiating clinical benefits, securing IP, and effective market penetration strategies.

FAQs

1. What indicates ANKTIVA's potential market share?
It depends on clinical trial results, approval timelines, and competitive positioning relative to existing biologics.

2. What are the primary regulatory hurdles for ANKTIVA?
FDA and EMA approval depend on demonstrating safety, efficacy, and manufacturing quality amidst evolving regulatory requirements.

3. How does biosimilar competition impact ANKTIVA?
Biosimilars could erode market share once patent protections expire, necessitating strategies for differentiation.

4. What pricing factors influence ANKTIVA’s market access?
Reimbursement negotiations, treatment cost, patient affordability, and clinical value propositions are key.

5. Can ANKTIVA’s revenue growth compensate for R&D investments?
Projection models suggest potential for strong growth post-approval, but early-stage uncertainties pose risks.

References

[1] BioPharm Insight. (2022). Biologic market trends and forecasts.
[2] Evaluate Pharma. (2023). Global autoimmune biologics market analysis.
[3] U.S. Food and Drug Administration. (2022). Biologics approval process.
[4] European Medicines Agency. (2023). Regulatory pathways for biologic drugs.