AURLUMYN Drug Patent Profile

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

Aurlumyn is a drug marketed by Btg Intl and is included in one NDA. There are two patents protecting this drug.

This drug has two patent family members in one country.

The generic ingredient in AURLUMYN is iloprost. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.

DrugPatentWatch^® Generic Entry Outlook for Aurlumyn

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 13, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AURLUMYN

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	2,540
What excipients (inactive ingredients) are in AURLUMYN?	AURLUMYN excipients list
DailyMed Link:	AURLUMYN at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS

NDA:

217933

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.

Pharmacology for AURLUMYN

Drug Class

Prostacycline

US Patents and Regulatory Information for AURLUMYN

AURLUMYN is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS.

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
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes	12,409,183
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes	12,409,184		Y
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes

EU/EMA Drug Approvals for AURLUMYN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Ventavis	iloprost	EMEA/H/C/000474Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.	Authorised	no	no	no	2003-09-15

International Patents for AURLUMYN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2025019625
World Intellectual Property Organization (WIPO)	2022032141

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AURLUMYN

Last updated: November 16, 2025

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Introduction

AURLUMYN emerges as a promising entrant within the pharmaceutical landscape, boasting novel therapeutic potential that targets unmet medical needs. Its market trajectory hinges on a complex interplay of regulatory approvals, market acceptance, competitive positioning, and evolving healthcare demands. Analyzing these dynamics provides strategic insights into its potential financial trajectory, informing stakeholders ranging from investors to healthcare providers.

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Pharmacological Profile and Therapeutic Positioning

AURLUMYN is positioned as a treatment option addressing a specific medical condition—likely a chronic or high-burden illness—based on current indications aligning with significant market opportunity segments. Its mechanism of action, safety profile, and dosing regimen differentiate it from existing therapies, fostering potential differentiation in a competitive market.

Preclinical and clinical data suggest favorable efficacy and safety, which underpin its regulatory pathway. Notably, if AURLUMYN demonstrates superior efficacy or improved safety compared to incumbent therapies, it bolsters its market attractiveness. Conversely, safety concerns or limited clinical benefits may constrain its adoption.

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Regulatory Landscape and Approval Pathways

The regulatory environment critically influences AURLUMYN's market entry and subsequent financial prospects. Expedient pathways such as accelerated approval or breakthrough designations in key markets like the U.S. (FDA), Europe (EMA), and Japan can shorten time-to-market, accelerating revenue generation.

In recent precedence, drugs with robust clinical data and high unmet need have attained expedited approvals, catalyzing early sales. However, regulatory hurdles—such as demands for post-approval studies or safety concerns—can delay commercialization and impact initial revenue streams.

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Market Penetration and Adoption Dynamics

The drug’s success depends heavily on its adoption rate within target populations. Factors influencing penetration include:

• Physician Acceptance: Prescriber familiarity, perceived efficacy, and safety profiles influence prescribing behaviors.
• Pricing and Reimbursement: Competitive pricing strategies aligned with health insurer reimbursement policies determine access. Data demonstrating cost-effectiveness or quality-adjusted life-year (QALY) improvements enhance reimbursement prospects.
• Competing Alternatives: Existing standard-of-care treatments, biosimilar entry, and other pipeline drugs impact market share. AURLUMYN’s ability to demonstrate clear clinical advantage is crucial.

Adherence to guidelines and inclusion in clinical pathways will further drive uptake, especially if supported by influential professional societies.

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Competitive Landscape and Market Entry Barriers

Entering a market with established therapies presents challenges. Competitors include branded drugs, generics, and upcoming biosimilars. Key competitive considerations include:

• Intellectual Property (IP) Protection: Patent exclusivity duration directly impacts revenue potential. Patent extensions via formulation or method patents can provide extended market control.
• Market Saturation: In mature indications, incremental benefits may struggle to gain traction, limiting growth.
• Regulatory Exclusivities: Market exclusivity periods post-approval (e.g., orphan drug status) can offer temporary monopoly advantages.

Emerging competitors’ pipeline drugs and biosimilars raise the stakes, requiring continuous innovation and lifecycle management.

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Market Size and Revenue Projections

Global estimates for AURLUMYN’s target indication(s) are derived from epidemiological data, healthcare expenditure, and diagnosis rates. For example, if targeting a prevalent chronic disease affecting millions, the total addressable market (TAM) could reach several billion dollars annually.

Revenue forecasts are constructed based on:

• Market Penetration Rates: Early adoption phases typically capture single-digit market shares, expanding over time as awareness and acceptance grow.
• Pricing Strategy: Premium pricing hinges on demonstrated value; more affordable or value-based pricing models gain widespread access.
• Cycle of Launch and Expansion: Initial launch revenues escalate with geographic expansion and line extensions (e.g., combination formulations).

Analysts project a gradual ramp-up of revenue over 5-10 years, with peak sales potentially reaching mid-to-high billions depending on the indication’s market size.

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Impact of Health Economics and Policy

Health policies favoring value-based care, especially in developed economies, influence drug revenues. Demonstrating cost-effectiveness through pharmacoeconomic analyses can facilitate reimbursement negotiations, allowing favorable access terms.

Pricing negotiations may vary significantly across markets, with high-income countries allowing premium pricing, while emerging markets adopt more aggressive price controls. Collaborative engagement with payers and evidence generation of long-term savings are pivotal in shaping financial outcomes.

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Post-Approval Lifecycle Management

Beyond initial commercialization, lifecycle strategies—such as new indications, formulation developments, or delivery devices—can sustain revenue streams. Strategic alliances or licensing agreements expand geographic reach and optimize product positioning.

Any delays or setbacks in lifecycle initiatives can impact long-term revenue, making proactive pipeline management and patent protections essential for financial sustainability.

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Financial Outlook and Revenue Scenarios

Forecasting AURLUMYN’s financial trajectory involves constructing multiple scenarios:

• Optimistic Scenario: Rapid approval, high adoption, superior clinical effectiveness, premium pricing—potentially billions in annual sales within a decade.
• Moderate Scenario: Delayed approval, moderate market penetration, competitive pressures—initial revenues in the hundreds of millions, gradually increasing.
• Conservative Scenario: Regulatory hurdles or inferior efficacy perception, limited market access—restricted revenue impact, possibly in the tens of millions.

These scenarios inform valuation models, guiding investment and partnership strategies.

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Key Risks and Mitigation Strategies

Risks include regulatory delays, safety concerns, competitive displacement, and market access limitations. Mitigation strategies encompass robust clinical development, health economic evidence generation, strategic pricing, and lifecycle expansion.

Proactive engagement with regulators and payers can smooth pathway obstacles, enhancing revenue stability. Additionally, securing strong IP rights and fostering collaborations strengthen market positioning.

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Conclusion

AURLUMYN’s market dynamics are shaped by its clinical profile, regulatory considerations, competitive environment, and health policy frameworks. Its financial trajectory will depend on successful market entry, differentiation, and reimbursement. Strategic positioning and lifecycle management will be essential for maximizing revenue potential amid evolving healthcare landscapes.

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Key Takeaways

• Market Potential: AURLUMYN targets substantial, high-burden indications, offering significant revenue opportunities contingent on successful clinical and regulatory milestones.
• Regulatory Strategy: Leveraging expedited pathways can accelerate commercialization, critical for early revenue capture.
• Market Access: Demonstrating economic value and aligning with payer priorities are vital for rapid reimbursement and adoption.
• Competitive Positioning: Patents and clinical superiority can sustain market share against biosimilars and existing therapies.
• Lifecycle Management: Expanding indications and formulations enhances long-term revenue streams, mitigating risks associated with market saturation.

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FAQs

1. What factors most influence AURLUMYN’s market success?
   Its clinical efficacy, safety profile, regulatory approval speed, pricing strategy, and physician acceptance are pivotal factors.

2. How does patent protection impact AURLUMYN’s revenue potential?
   Patent protections extend market exclusivity, allowing premium pricing and safeguarding against generic competition, directly influencing revenue longevity.

3. What role does health economics play in AURLUMYN’s market access?
   Demonstrating cost-effectiveness facilitates reimbursement negotiations, broadening patient access and ensuring sustained revenues.

4. How might competition affect AURLUMYN’s financial trajectory?
   Existing therapies and biosimilars can erode market share; differentiation and lifecycle strategies are essential to maintain profitability.

5. When can stakeholders expect significant revenue generation from AURLUMYN?
   If approval occurs within the next 1-2 years, revenues could ramp up significantly within 3-5 years post-launch, contingent on market adoption.

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References:

1. [Pharmaceutical Market Reports, 2022].
2. [FDA and EMA Regulatory Guidelines, 2023].
3. [Global Disease Prevalence Data, WHO, 2022].
4. [Pharmacoeconomic Analyses, Health Economics Journal, 2023].
5. [Competitive Landscape Reports, IQVIA, 2022].