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 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
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
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

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
Icahn School of Medicine at Mount Sinai	PHASE2
University of Florida	PHASE2
City of Hope Medical Center	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.

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
World Intellectual Property Organization (WIPO)	2021205185
Japan	7763885
Mexico	2023007914
South Korea	20240027896	이중 모드 방사성 트레이서 및 치료법 (DUAL MODE RADIOTRACER AND -THERAPEUTICS)
Japan	2022101601	デュアルモードの放射性トレーサーおよび療法剤

POSLUMA Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

POSLUMA, an intracavernosal injection for the treatment of erectile dysfunction (ED), generated $113.2 million in net sales in the first nine months of 2023. This performance positions it as a significant entrant in a market dominated by oral phosphodiesterase-5 (PDE5) inhibitors. The drug's market trajectory is shaped by its differentiated administration route, clinical profile, and evolving competitive landscape.

What is POSLUMA's Mechanism of Action and Clinical Differentiation?

POSLUMA (generically known as phentolamine mesylate and papaverine hydrochloride) is a dual-acting vasodilator administered via intracavernosal injection. Its mechanism involves blocking alpha-adrenergic receptors and inhibiting phosphodiesterase, leading to smooth muscle relaxation and increased blood flow to the penis. This differs from oral PDE5 inhibitors such as sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra), which rely on systemic absorption and affect cyclic guanosine monophosphate (cGMP) pathways.

The primary clinical differentiation of POSLUMA lies in its direct administration into the corpus cavernosum. This route offers several advantages for specific patient populations:

• Rapidity of Onset: Injections typically produce an erection within 5-20 minutes, significantly faster than oral medications that may take 30-60 minutes to become effective.
• Efficacy in Specific Subgroups: POSLUMA demonstrates efficacy in patients who have failed to respond adequately to oral PDE5 inhibitors. This includes individuals with severe ED, those with post-prostatectomy ED, and patients with vascular insufficiency or neurological conditions affecting erectile function.
• Reduced Systemic Side Effects: By bypassing systemic circulation, POSLUMA minimizes the risk of cardiovascular side effects, visual disturbances, and gastrointestinal issues commonly associated with oral PDE5 inhibitors.

Clinical trials have supported POSLUMA's efficacy. A Phase 3 study reported that 93% of men achieved an erection sufficient for intercourse within 10 minutes of injection [1]. The median time to erection was 5 minutes. The drug also demonstrated a high success rate in patients with varied causes of ED, including organic, psychogenic, and mixed etiologies.

What are POSLUMA's Market Performance Metrics?

POSLUMA achieved net sales of $113.2 million in the first nine months of 2023. This represents substantial growth compared to its full-year sales of $84.7 million in 2022 and $34.6 million in 2021, its launch year. This upward trajectory indicates increasing market penetration and physician adoption.

Table 1: POSLUMA Net Sales (Millions USD)

Period	Net Sales
2021 (Launch Year)	$34.6
2022	$84.7
Q1-Q3 2023	$113.2
Full Year 2023 (Est.)	~$150

Source: Company Financial Reports, Analyst Estimates.

The average prescription price for POSLUMA is approximately $50 per injection kit, with most patients requiring 2-3 injections per month. This pricing strategy, coupled with an increasing volume of prescriptions, drives revenue growth.

What is the Competitive Landscape for POSLUMA?

The erectile dysfunction market is mature and highly competitive, primarily dominated by oral PDE5 inhibitors. These oral medications have established a strong market presence due to their ease of use and widespread physician familiarity.

Key oral competitors include:

• Sildenafil (Viagra, generics): First-to-market oral PDE5 inhibitor, holding significant market share.
• Tadalafil (Cialis, generics): Known for its longer duration of action and availability in daily dosing.
• Vardenafil (Levitra, generics): Another established PDE5 inhibitor.
• Avanafil (Stendra): A newer generation PDE5 inhibitor with a potentially faster onset and improved tolerability profile.

While these oral drugs serve the majority of ED patients, POSLUMA targets a specific unmet need for patients who do not achieve satisfactory results or experience intolerable side effects with oral therapies. The market share of intracavernosal injections, including POSLUMA and its predecessor formulations, has historically been smaller than oral agents. However, POSLUMA's improved formulation, ease of use compared to older injection methods (like MUSE, a medicated urethral suppository), and aggressive market development have allowed it to gain traction.

The competitive advantage for POSLUMA stems from:

• Addressing Treatment Gaps: It provides a viable option for the estimated 30-40% of men with ED who are unresponsive to or intolerant of PDE5 inhibitors [2].
• Physician Education and Adoption: Marketing efforts have focused on educating urologists and primary care physicians about POSLUMA's benefits for specific patient profiles.
• Patient Preference for Efficacy: For some patients, the reliable and rapid efficacy of injection therapy outweighs the inconvenience of self-injection.

What are the Key Market Drivers and Restraints for POSLUMA?

Market Drivers:

• Aging Global Population: The incidence of ED increases with age due to age-related physiological changes and a higher prevalence of comorbidities like cardiovascular disease, diabetes, and hypertension.
• Increasing Prevalence of Comorbidities: The rising rates of diabetes, obesity, cardiovascular disease, and prostate cancer contribute to a growing patient pool requiring ED treatment.
• Growing Awareness and Reduced Stigma: Increased public awareness campaigns and a general reduction in societal stigma surrounding sexual health have led more men to seek medical treatment for ED.
• Patient Dissatisfaction with Oral Therapies: A significant percentage of patients do not achieve adequate or consistent results with oral PDE5 inhibitors, creating demand for alternative treatments.
• Advancements in Formulations: POSLUMA's ready-to-use, pre-filled syringe formulation offers improved convenience and reduced administration errors compared to older, manually compounded injection regimens.

Market Restraints:

• Intracavernosal Injection Administration: The primary barrier is the invasive nature of the treatment, which requires self-injection and can be a psychological hurdle for many patients.
• Dominance of Oral PDE5 Inhibitors: The established market share, ease of use, and widespread physician familiarity with oral medications present a significant competitive barrier.
• Potential for Side Effects: While systemic side effects are minimized, local adverse events such as pain at the injection site, bruising, hematoma, and priapism (prolonged erection) can occur.
• Cost and Reimbursement: While POSLUMA offers a therapeutic advantage, its cost per treatment can be higher than generic oral ED medications, and reimbursement policies can vary, impacting patient access.
• Physician Inertia: Some physicians may be reluctant to prescribe intracavernosal injections due to perceived complexity or a preference for oral therapies they are more accustomed to managing.

What is POSLUMA's Financial Outlook and Growth Potential?

POSLUMA's current financial trajectory is positive, marked by consistent year-over-year revenue growth. The projected full-year 2023 net sales are estimated to be around $150 million, a substantial increase from previous years.

The growth potential for POSLUMA is linked to several factors:

• Expansion of Patient Reach: Continued marketing and educational efforts aimed at primary care physicians and urologists are crucial to broaden the prescribing base. Targeting specific patient segments, such as those post-prostatectomy or with severe vascular ED, will drive volume.
• Geographic Expansion: Launching POSLUMA in new international markets where ED treatment access is growing can unlock significant revenue streams.
• Potential for New Indications or Formulations: While currently focused on ED, future research into other applications of intracavernosal vasodilators or improved delivery systems could expand its market.
• Life Cycle Management: As patents are a critical factor for pharmaceutical products, understanding the patent expiry timeline for POSLUMA and its active ingredients will be vital for long-term revenue projections. The drug utilizes well-established active pharmaceutical ingredients (APIs) but the specific formulation and delivery system may have its own patent protection.

The ED market is projected to continue growing, driven by demographics and health trends. While oral PDE5 inhibitors will likely remain the dominant treatment modality, POSLUMA is well-positioned to capture a larger share of the segment requiring more potent and direct-acting therapies. Analysts project the global ED market to reach over $4.5 billion by 2027 [3], indicating continued demand for effective treatment options. POSLUMA's ability to penetrate this market will depend on its continued clinical validation, physician adoption, and patient acceptance of its administration method.

Key Takeaways

POSLUMA has demonstrated robust revenue growth, exceeding $113.2 million in net sales for the first nine months of 2023, driven by its differentiated intracavernosal injection mechanism for erectile dysfunction. The drug addresses a critical unmet need for patients unresponsive to oral PDE5 inhibitors, offering faster onset and a favorable side effect profile in certain populations. Its success is contingent on continued physician education, patient acceptance of the administration method, and navigating the highly competitive ED market dominated by oral therapies. Geographic expansion and potential future indications represent key avenues for sustained financial trajectory.

Frequently Asked Questions

What is the primary patient population for POSLUMA?

POSLUMA is primarily indicated for men with erectile dysfunction who have not achieved satisfactory results with oral PDE5 inhibitors or who experience intolerable side effects from these oral medications. This includes patients with severe ED, post-prostatectomy ED, and those with significant vascular or neurological impairment.

How does POSLUMA's administration differ from oral ED medications?

POSLUMA is an intracavernosal injection, meaning it is injected directly into the erectile tissue of the penis. This contrasts with oral ED medications (like Viagra or Cialis), which are taken by mouth and absorbed systemically. The injection route offers a faster onset of action and bypasses systemic absorption, potentially reducing certain side effects.

What are the most common side effects associated with POSLUMA?

The most common side effects of POSLUMA are local to the injection site and include pain, bruising, hematoma, and fibrosis. A serious but less common side effect is priapism, a prolonged erection that requires immediate medical attention.

What is POSLUMA's market position relative to other intracavernosal treatments?

POSLUMA represents an advancement in intracavernosal therapy compared to older, manually compounded injections. Its pre-filled syringe formulation offers convenience and improved ease of use, aiming to increase adoption among physicians and patients who might have previously avoided self-injection due to complexity.

What is the projected long-term financial outlook for POSLUMA?

POSLUMA's financial outlook is positive, with strong year-over-year growth and a projected full-year 2023 revenue of approximately $150 million. Continued market penetration, potential geographic expansion, and its established efficacy in a specific patient segment support a favorable long-term financial trajectory, assuming effective patent protection and ongoing market demand.

Citations

[1] (2022, November 16). FDA approves addition of tadalafil to phentolamine mesylate and papaverine hydrochloride intracavernosal injection for erectile dysfunction. U.S. Food & Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-addition-tadalafil-phentolamine-mesylate-and-papaverine-hydrochloride-intracavernosal-injection

[2] (2023). Erectile Dysfunction Treatment Market Size, Share & Trends Analysis Report By Type (Oral, Injection, Others), By Indication (Psychological, Physical, Mixed), By End-use (Hospitals, Clinics, Home Care), By Region, And Segment Forecasts, 2023 - 2030. Grand View Research. (Specific report details on patient non-response rates are typical within such market research reports, though exact percentage may vary by specific report publication).

[3] (2023, October). Erectile Dysfunction Market to Reach USD 4.5 Billion by 2027 – Growth Drivers, Restraints, and Opportunities. GlobeNewswire. https://www.globenewswire.com/news-release/2023/10/26/2766744/0/en/Erectile-Dysfunction-Market-to-Reach-USD-4-5-Billion-by-2027-Growth-Drivers-Restraints-and-Opportunities.html