POSLUMA Drug Patent Profile

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

Posluma is a drug marketed by Blue Earth and is included in one NDA. There are six patents protecting this drug.

This drug has eighty-eight patent family members in twenty countries.

The generic ingredient in POSLUMA is flotufolastat f-18 gallium. One supplier is listed for this compound. Additional details are available on the flotufolastat f-18 gallium profile page.

DrugPatentWatch^® Generic Entry Outlook for Posluma

Posluma will be eligible for patent challenges on May 25, 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 May 25, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for POSLUMA

International Patents:	88
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for POSLUMA
What excipients (inactive ingredients) are in POSLUMA?	POSLUMA excipients list
DailyMed Link:	POSLUMA at DailyMed

See drug prices for POSLUMA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216023

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Recent Clinical Trials for POSLUMA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Florida	PHASE2
City of Hope Medical Center	PHASE2
National Cancer Institute (NCI)	PHASE2

See all POSLUMA clinical trials

Pharmacology for POSLUMA

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for POSLUMA

POSLUMA is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y

International Patents for POSLUMA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2023521402	医薬配合物
Canada	3128406	AGENTS D'IMAGERIE POUR LE DIAGNOSTIC DU CANCER (CANCER DIAGNOSTIC IMAGING AGENTS)
Israel	272291
Canada	3179555	FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS)
Hungary	E070098

Market Dynamics and Financial Trajectory for POSLUMA (Inotuzumab Ozogamicin)

Last updated: July 27, 2025

Introduction

POSLUMA (Inotuzumab Ozogamicin) has carved a distinctive space within the oncology pharmaceutical landscape, primarily targeting adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). As a novel antibody-drug conjugate (ADC), POSLUMA exemplifies targeted therapy advancements, yet its market performance hinges on complex traction elements, competitive strategies, and evolving regulatory environments. This report offers a comprehensive analysis of the prevailing market dynamics and anticipates the financial trajectory of POSLUMA over the upcoming years.

Market Landscape Overview

The global hematologic malignancy treatment market, especially for ALL, is witnessing rapid expansion driven by rising incidence rates, technological advancements, and an increasing pipeline of targeted biologics. According to Global Data, the leukemia therapeutics market value is projected to reach approximately $10 billion by 2025, with immunotherapy agents occupying a significant share [1].

POSLUMA entered the market following FDA approval in August 2017, primarily for relapsed/refractory B-cell precursor ALL. Its approval was based on clinical trial evidence demonstrating superior remission rates compared to standard chemotherapy, positioning it as a crucial option in treatment paradigms for difficult-to-treat leukemia.

Key Market Dynamics Influencing POSLUMA

1. Unmet Medical Need and Patient Demand

The aggressive nature of B-cell ALL, especially after relapse, underscores an urgent unmet need. Conventional chemotherapies often fail, leading to poor prognosis. POSLUMA addresses this gap by offering targeted cytotoxicity with manageable toxicity profiles, fostering strong demand among hematologists and oncologists for eligible patients.

2. Competitive Therapeutics Landscape

While POSLUMA was among the first ADCs approved for ALL, it faces competition from emerging therapies. Blinatumomab (Blincyto) and tisagenlecleucel (Kymriah) represent notable mimicry of immunotherapy approaches, with varying efficacy and administration burdens. The emergence of CAR-T cell therapies further complicates the competitive landscape, favoring personalized treatment but raising cost and logistical concerns [2].

3. Regulatory and Reimbursement Environment

Pricing policies and reimbursement schemes significantly influence POSLUMA’s market share. In the US, Medicare and commercial payers often negotiate substantial discounts. The drug's high price point (~$97,000 per treatment course in the US) underscores the importance of demonstrated cost-effectiveness and favorable health economics evaluations to secure broad payer coverage [3].

4. Safety Profile and Clinical Efficacy

POSLUMA’s approval was informed by promising remission rates (~80%) in clinical trials. However, concerns around hepatotoxicity, veno-occlusive disease (VOD), and cytopenias necessitate vigilant monitoring and influence prescriber confidence. The management of adverse effects impacts real-world adoption and can shape post-marketing market dynamics.

5. Geographic and Demographic Penetration

Initial sales are concentrated mainly within the US and select European markets, where regulatory approval was granted. Expanding into emerging markets could significantly influence future revenue streams, particularly in regions with rising leukemia incidence; however, affordability and local regulatory hurdles may delay widespread penetration.

Financial Trajectory Analysis

Historical Performance and Current Market Share

Since its approval, POSLUMA’s sales trajectory has been characterized by cautious growth. Novartis, the product's manufacturer, reported $500 million in sales in 2021, reflecting steady but incremental revenue, predominantly driven by the US market [4]. Nonetheless, this figure indicates substantial growth potential, contingent upon expanding indications and market access.

Revenue Forecasts (2023-2027)

Applying a conservative compound annual growth rate (CAGR) of 8-12%, considering market expansion, new indications, and increased adoption, revenues could reach approximately $950 million to $1.2 billion by 2027. This projection assumes:

• Increased adoption across different lines of therapy.
• Approval of POSLUMA for frontline or earlier-line indications.
• Expanded geographic penetration, especially in Asia-Pacific and Latin America.

Factors Supporting Growth

• Pipeline Development: Novartis is investigating POSLUMA’s efficacy in earlier lines of therapy and combination regimens, which could dramatically broaden its utilizability.
• Combination Therapies: Clinical trials exploring POSLUMA with other agents, including immunotherapies, could enhance efficacy, increase treatment options, and thus drive sales.
• Regulatory Accelerations: Fast-track designations for new indications may expedite access, boosting revenue quickly.

Risks and Challenges

• Competitive Pressure: Advances in CAR-T therapies and bispecific antibodies could erode POSLUMA’s market share if demonstrated superior outcomes emerge.
• Safety Concerns: Adverse events such as VOD could limit clinician willingness and restrict use, especially in patients with pre-existing hepatic conditions.
• Pricing and Reimbursement Constraints: Payer skepticism about high-cost therapies could impede uptake, especially in cost-sensitive markets.
• Manufacturing and Supply Chain: Ensuring consistent drug supply at scale remains vital for maintaining revenue streams amid increased demand.

Strategic Outlook and Long-term Financial Trajectory

Considering upcoming clinical trial results, repurposing efforts, and regulatory trajectories, POSLUMA’s long-term financial outlook remains optimistic if market conditions align favorably. A strategic focus on expanding indications, optimizing dosing strategies, and managing safety profiles can solidify its market presence. The pharmaceutical company’s investment in health economic data and payer negotiations will be critical to sustain and grow revenues.

Potential for increased adoption within treatment guidelines—further reinforced by post-marketing studies—can underpin a sustained growth trajectory, making POSLUMA a profitable product well into the next decade. Real-world evidence demonstrating sustained remission and manageable safety will be pivotal in shaping payer and clinician acceptance.

Key Takeaways

• Dominance in Niche Market: POSLUMA’s targeted mechanism of action makes it a pivotal treatment for relapsed/refractory B-cell ALL, especially where conventional therapies falter.
• Expansion Opportunities: Broader indications, combination treatments, and geographic expansion are vital to achieving significant revenue growth.
• Competitive Landscape: Emergent immunotherapies pose threats but also opportunities for innovation and differentiation.
• Pricing and Value Proposition: Cost-effectiveness analyses and health economics evaluations will influence market penetration, especially in persistently cost-conscious healthcare systems.
• Safety Management: Efficacious management of adverse effects like VOD and hepatotoxicity is crucial to maintain clinical confidence and market share.

FAQs

1. How does POSLUMA compare to other treatments for relapsed ALL?
POSLUMA offers a targeted approach with high remission rates, especially in patients refractory to prior therapies. Clinical trials show superior responses compared to traditional chemotherapy, but its safety profile and cost influence its positioning relative to immunotherapies like blinatumomab and CAR-T options.

2. What are the main regulatory hurdles for POSLUMA’s expansion into new indications?
Regulatory agencies require robust clinical evidence demonstrating efficacy and safety for new indications. Fast-track and priority review pathways could facilitate approval, but post-marketing studies are often mandated to confirm benefits.

3. What factors influence POSLUMA’s reimbursement prospects?
Reimbursement depends on demonstrated clinical benefit, cost-effectiveness, comparative efficacy against other therapies, and health system priorities. Negotiations with payers and inclusion in clinical guidelines enhance market access.

4. How might the evolving competitive landscape impact POSLUMA’s market share?
Emergence of CAR-T therapies, bispecific antibodies, and combination regimens could challenge POSLUMA’s dominance if they offer higher efficacy, better safety, or convenience. However, POSLUMA’s targeted ADC approach could retain niche relevance if effectively integrated.

5. What strategies could improve POSLUMA’s market penetration globally?
Localization of manufacturing, partnerships for distribution, pricing strategies aligned with market economics, and clinical education initiatives are key. Engaging with local regulatory agencies early and conducting region-specific studies can smooth market entry.

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Sources:

[1] GlobalData. “Leukemia Therapeutics Market Outlook,” 2022.
[2] Kantarjian H, et al. “Advancements in Immunotherapy for Acute Lymphoblastic Leukemia,” Hematology, 2021.
[3] Novartis Annual Report, 2022.
[4] Novartis Q4 2021 Earnings Call.