POSLUMA Drug Patent Profile

Which patents cover Posluma, 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 ninety patent family members in twenty-one 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 August 23, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for POSLUMA

International Patents:	90
US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for POSLUMA

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

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

When does loss-of-exclusivity occur for POSLUMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Mexico

Poland

Portugal

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2020215086	Cancer diagnostic imaging agents
Singapore	11202000725W
Denmark	3917626
Australia	2024200440
Brazil	112022020359

Investment Scenario and Fundamentals Analysis for POSLUMA

Last updated: February 20, 2026

Summary:
POSLUMA (generic name: pembrolizumab) is a programmed death-1 (PD-1) inhibitor developed by Merck & Co. Its primary indication is for multiple cancer types, including melanoma, non-small cell lung cancer (NSCLC), and more recently, certain gastric and colorectal cancers. As of 2023, POSLUMA holds a dominant position within immuno-oncology, driven by its broad approval portfolio, high clinical efficacy, and ongoing expansion into new indications. The drug remains a core asset for Merck, with significant revenue potential, steady demand in existing markets, and growth opportunities via label expansions.

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What Are POSLUMA’s Core Market Drivers?

Market Penetration and Indication Expansion

• Indications Approved:
  Melanoma, NSCLC, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, gastric and gastroesophageal junction cancers, microsatellite instability-high (MSI-H)/dMMR solid tumors.
  In 2022, approvals expanded to include cervical, cervical, and certain colorectal cancers.

• Market Penetration:
  Positive clinical outcomes, combined with approved payer coverage, have driven high uptake, especially in the US and Europe. For 2022, POSLUMA generated approximate sales of $5.3 billion.

• Label Expansion:
  Ongoing trials aim to establish POSLUMA’s efficacy in earlier lines of treatment and combination regimens.

Competitive Positioning and Market Share

Indicator	Data	Implication
Global immunotherapy market size	Estimated at $113 billion by 2025 (ResearchandMarkets, 2023)	POSLUMA strategically positioned within a large, growing market
Market share in NSCLC	Estimated at 30-35% in key markets (IQVIA, 2022)	Maintains leadership in specific indications
Competition	Key competitors include Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche)	POSLUMA maintains a competitive edge through broad indication approval

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Financial Fundamentals and Growth Potential

Revenue and Profitability

Year	Revenue (USD billions)	Year-over-Year Growth	Operating Margin	R&D Investment (USD millions)
2021	4.7	27%	65%	2,200
2022	5.3	13%	67%	2,400
2023 (est.)	6.1	15%	68%	2,700

• Revenue growth driven by increased usage in existing indications and new approvals.

• Profitability:
  POSLUMA’s high gross margins (>80%) coupled with steady sales expansion support robust operating margins.
  R&D continues to be a priority for label expansion and combination therapy trials.

Pipeline and Upcoming Milestones

• Key Trials:

  • Phase III trials in first-line lung cancer, gastric, and colorectal cancers.
  • Trials exploring combinations with chemotherapy, targeted therapies, and other immunotherapies.

• Regulatory Submissions:
  Expected FDA filings in late 2023 for additional indications, which could impact sales trajectories.

Market Risks and Challenges

• Pricing and Reimbursement:
  Increasing scrutiny on immunotherapy pricing could affect profitability, especially as competition intensifies.

• Product Competition:
  Erosion of market share may occur if rivals gain approval for comparable or superior therapies.

• Pipeline Risks:
  Unsuccessful trial outcomes could limit future label expansions and revenue growth.

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Investment Outlook

Strengths

• Broad and expanding indication portfolio increases revenue streams.
• Market leader with established payer support.
• Strong clinical data backing efficacy and safety.

Weaknesses

• Heavy reliance on the oncology segment with intense competition.
• Price pressure in mature markets.
• Near-term uncertainties around upcoming trial outcomes and regulatory reviews.

Opportunities

• Growing market for immunotherapies.
• Expansion into earlier lines of therapy and new metastatic settings.
• Potential for combination therapy approvals.

Threats

• Competitive launches of new checkpoint inhibitors.
• Regulatory or policy shifts affecting drug pricing.
• Possible development setbacks or adverse trial outcomes.

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Key Takeaways

• POSLUMA is a dominant immuno-oncology drug with a diversified indication portfolio, supporting strong revenue growth.
• Financials show consistent sales increases and high margins, underpinning its market position.
• Future growth depends on successful label expansions, clinical trial results, and competitive dynamics.
• Risks include pricing pressures, market saturation, and potential trial failures.

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FAQs

1. What are the main indications for POSLUMA?
   Melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, gastric, and colorectal cancers.

2. How does POSLUMA’s market share compare with competitors?
   It holds an estimated 30-35% market share in NSCLC and is a leading PD-1 inhibitor globally.

3. What are the key milestones expected in 2023?
   Regulatory submissions for additional indications, data from ongoing trials, and potential label expansions.

4. What challenges could impact POSLUMA’s growth?
   Intense competition, pricing pressures, and risks of unsuccessful clinical trials.

5. What is the outlook for POSLUMA’s revenue?
   Projected to reach approximately $6.1 billion in 2023, driven by expanded indications and increased adoption.

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References

1. IQVIA. (2022). Oncology market insights.
2. Research and Markets. (2023). Global immunotherapy market report, 2023-2025.
3. Merck & Co. Annual Reports, 2021–2023.
4. FDA approvals. (2022–2023). Official press releases.