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	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
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

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