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 five patent family members in four countries.

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:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	2,651
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
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			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
China	121772928	使用伊洛前列素用于治疗冻伤的方法 (Methods of using iloprost for treating frostbite)
Denmark	202630963	METHOD OF USING ILOPROST FOR TREATING FROSTBITE
European Patent Office	4746889	PROCÉDÉ D'UTILISATION DE L'ILOPROST POUR LE TRAITEMENT DE GELURES (METHOD OF USING ILOPROST FOR TREATING FROSTBITE)
World Intellectual Property Organization (WIPO)	2025019625
World Intellectual Property Organization (WIPO)	2022032141

Last updated: June 25, 2026

Aurlumyn market dynamics and financial trajectory: pricing, access, competition, and payer risk

Aurlumyn’s market dynamics and financial trajectory depend on (1) its FDA commercialization status and launch timing, (2) Orange Book and exclusivity barriers that shape generic and biosimilar entry risk, and (3) payer contract design that drives net price, volume, and channel mix. No market sizing, revenue history, payer coverage metrics, or FDA/Orange Book status data for “Aurlumyn” is available in the provided materials, so a complete, accurate financial trajectory cannot be produced.

What is Aurlumyn (and which indication drives revenue)?

No drug identity, active ingredient, strength/dosage form, manufacturer, NDC set, indication, or FDA approval date is provided for “Aurlumyn,” so market dynamics cannot be mapped to a specific commercial product.

What market dynamics determine Aurlumyn net revenue?

Without product identity and regulatory details, the drivers below cannot be quantified for Aurlumyn:

• Launch sequence and ramp schedule (TRx-to-revenue conversion requires NDC-level distribution and channel data)
• Net price versus WAC (needs contract benchmarks, rebates, and payer mix)
• Patient access (coverage rate and formulary tiering by PBMs and plans)
• Competitive pressure (requires identifying label competitors and therapeutic alternatives)
• Switch and substitution rules (requires formulation, interchangeability, and therapeutic equivalence status)

How do exclusivity and patent barriers affect Aurlumyn pricing power?

No Orange Book listings, patent numbers, expiration dates, or exclusivity codes are provided for Aurlumyn. Without that, the timeline to generic/authorized generic entry and the effect on pricing cannot be determined.

What is Aurlumyn’s litigation and Paragraph IV risk profile?

No patent-litigation docket, settlement dates, or Paragraph IV notices are provided for Aurlumyn. A financial trajectory depends on expected entry dates, launch-at-risk scenarios, and any bottleneck from injunctions or exclusivity triggers.

What generic entry risks exist for Aurlumyn?

A credible generic-entry risk requires:

• FDA Orange Book patent-to-drug mapping
• Whether the product has REMS, interchangeability constraints, or formulation-specific exclusivity
• Any filed ANDA data indicating likely carve-outs, launch windows, and design-arounds
  None of this is available for Aurlumyn in the provided information.

How does Aurlumyn compare with competing drugs in the same class?

No active ingredient, mechanism, dosing regimen, or indication is provided, so competitive set construction is not possible. Without a defined comparator set, impact on utilization, share, and pricing cannot be analyzed.

What is the Orange Book status of Aurlumyn?

No Orange Book entry, patent list, or exclusivity status is provided for Aurlumyn, so Orange Book risk and timing cannot be produced.

What FDA pathway and label scope affect Aurlumyn adoption?

A financial trajectory depends on label strength and clinical positioning (for example, comparative endpoints, safety profile, subpopulation coverage, and any restrictions). None of those FDA label facts are provided for Aurlumyn.

How do manufacturing and supply constraints change the revenue ramp?

No manufacturer, CMO dependencies, capacity, supply history, or shortage/discontinuation signals are provided for Aurlumyn. Supply constraints are a key variable in early revenue realization.

Timeline: what milestones would map to Aurlumyn revenue growth?

Aurlumyn-specific milestones cannot be built without at least: FDA approval date, launch date, distribution start, coverage decisions, and any known payer contract renewals. No such dates are provided.

Financial trajectory: what revenue path can be modeled for Aurlumyn?

A revenue trajectory requires:

• Time series: TRx, prescriptions, patient starts, or sales history
• Pricing: WAC and net realization, discounting and rebate structure
• Market access: formulary status, prior authorization, step edits
• Forecast inputs: competitor entry timing, patent expiry, and segment growth
  None of the required product- and market-specific inputs for Aurlumyn are available here.

Key Takeaways

• A market- and finance-grade trajectory for “Aurlumyn” cannot be produced without product identity (active ingredient/indication/manufacturer) and regulatory and commercial data (FDA status, Orange Book, payer coverage, sales history).
• The revenue ramp and pricing dynamics for a branded pharmaceutical are driven by exclusivity timelines, payer contract structure, and competitive entry timing, none of which can be mapped to Aurlumyn from the provided information.

FAQs

1. What is the FDA approval status of Aurlumyn?
2. Does Aurlumyn have Orange Book-listed patents, and when do they expire?
3. Have any ANDAs or Paragraph IV challenges been filed for Aurlumyn?
4. What payer coverage rules (PA, step edits) affect Aurlumyn formulary access?
5. Which drugs compete directly with Aurlumyn for the same indication and line of therapy?

References

No sources were provided in the prompt to cite.