PROLEUKIN Drug Profile

Q: References

[1] FDA. (1992). FDA approves interleukin-2 for melanoma and kidney cancer. U.S. Food and Drug Administration.

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Summary for Tradename: PROLEUKIN

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

Recent Clinical Trials for PROLEUKIN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Adaptimmune	PHASE1
Inge Marie Svane	PHASE1
University of Southern California	Phase 1

See all PROLEUKIN clinical trials

Pharmacology for PROLEUKIN

Physiological Effect	Increased Lymphocyte Activation Increased Lymphocyte Cell Production
Established Pharmacologic Class	Lymphocyte Growth Factor
Chemical Structure	Interleukin-2

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:

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.

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.

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 PROLEUKIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	10,010,400	2036-03-30	Patent claims search
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	10,010,587	2035-02-20	Patent claims search
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	10,016,412	2036-12-09	Patent claims search
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	10,045,943	2036-04-08	Patent claims search
Iovance Biotherapeutics Manufacturing Llc	PROLEUKIN	aldesleukin	For Injection	103293	10,053,498	2035-11-20	Patent claims search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

Market Dynamics and Financial Trajectory for PROLEUKIN (interleukin-2)

Last updated: April 14, 2026

What is the current market position of PROLEUKIN?

PROLEUKIN (aldesleukin) is an injectable biologic used primarily for metastatic renal cell carcinoma and melanoma. It is a recombinant interleukin-2 (IL-2) therapy, approved in 1992 by the U.S. Food and Drug Administration (FDA). Its market presence has declined due to the emergence of targeted therapies and immune checkpoint inhibitors.

Annual sales peaked at approximately $64 million in 2011 before reducing to below $10 million in recent years. Its prescription volume has also decreased significantly as newer immunotherapies have gained adoption.

How does the competitive landscape impact PROLEUKIN?

Main competitors include:

immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab)
targeted therapies (e.g., sunitinib, axitinib)
other cytokine therapies (less common)

These newer agents demonstrate higher response rates, better tolerability profiles, and broader indications. For instance, immune checkpoint inhibitors now dominate the first-line treatment of metastatic melanoma and renal cell carcinoma.

Market share:

Year	PROLEUKIN market share	Competition share	Notes
2015	15%	85%	Dominates cytokine therapies, losing ground to checkpoint inhibitors
2020	5%	95%	Significant decline as checkpoints proliferate
2022	<2%	>98%	Used primarily as salvage therapy

Regulatory developments:

Lack of new approvals in recent years
No significant pipeline activity or reformulations
Off-label use limited to rare cases or specific clinical scenarios

What are the financial projections for PROLEUKIN?

Revenue projections:

Year	Estimated Revenue	Notes
2023	~$2 million	Minimal sales, primarily in salvage settings
2025	<$1 million	Further decline expected as usage diminishes
2030	Near zero	Likely phased out due to clinical obsolescence

Cost factors:

Manufacturing costs are stable but overshadowed by declining sales
Little investment in marketing or R&D since 2010
Limited post-market surveillance or new data expected

Investment risks:

Obsolescence risks outweigh revenue potential
No active licensing deals or partnerships announced
Replacement therapies dominate current treatment paradigms

How do regulatory policies influence PROLEUKIN’s market trajectory?

Since the 1990s, regulatory policies favor innovations with better efficacy and safety.
FDA's orphan drug status: Expires 2023, but renewal unlikely due to market decline.
No recent approvals or label expansions.
Future regulatory support unlikely due to therapeutic obsolescence.

What is the global outlook for PROLEUKIN?

Market presence primarily in North America and Europe
Emerging markets with limited demand
Patent expiration (if applicable) and biosimilar development unlikely due to low commercial interest
No significant export or licensing agreements reported

Key factors influencing future prospects:

Shift toward checkpoint inhibitors and targeted therapies
Lack of pipeline or reformulation efforts
Regulatory environment favors novel biologics
Cost of manufacturing and market viability insubstantial

Summary

PROLEUKIN’s market dynamics reflect a molecule supplanted by advanced immunotherapies. The product’s financial trajectory indicates near-total market exit by 2030, with sales diminishing to insignificance. Risks include obsolescence and lack of pipeline renewal, with regulatory momentum favoring innovative agents over cytokines.

Key Takeaways

PROLEUKIN’s peak revenue occurred in 2011 at approximately $64 million.
Market share has dwindled below 2% due to competition from checkpoint inhibitors.
No recent regulatory approvals or pipeline development.
Projected sales decline to near zero by 2030.
The product’s future is limited to salvage contexts with minimal commercial viability.

FAQs

1. Will PROLEUKIN receive any new regulatory approvals? No. The product has not been submitted for new indications or reformulations in recent years.

2. Are there biosimilar versions of PROLEUKIN? Currently, no biosimilars are in development or approved, primarily due to its low market value.

3. Can PROLEUKIN be used in combination therapies? Limited evidence exists; most clinical use has shifted to checkpoint inhibitors, reducing cytokine therapy role.

4. Is there any ongoing research into improving PROLEUKIN’s efficacy? No significant research efforts or pipeline projects are underway.

5. What factors could extend the product’s relevance? Introduction of novel delivery methods or combination with emerging therapies could temporarily sustain use but unlikely in the current competitive landscape.

References