Question 1

Is there a generic for Iloprost?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Iloprost. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Iloprost?

Accepted Answer

AURLUMYN (NDA 217933, BTG INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Iloprost?

Accepted Answer

The Orange Book lists 2 patents against Iloprost products, with the earliest listed expiry in 2041. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Iloprost have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Iloprost. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Iloprost are approved?

Accepted Answer

Iloprost is approved in the following dosage form: solution.

Product	Applicant	Application	TE	Approved
AURLUMYNRLD	BTG INTL	NDA 217933	—	Feb 13, 2024
VENTAVISRLD×3	ACTELION	NDA 021779	—	Dec 08, 2005

Patent	Expires	In	Type
12409184	Aug 06, 2041	in 15 yr 4 mo	Product
12409183	Jul 18, 2044	in 18 yr 4 mo	U-4263

Iloprost

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (2)

Iloprost — frequently asked questions

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