Is Aurlumyn still available?

Yes. Aurlumyn (NDA 217933) is listed with marketing status Prescription in the FDA Orange Book.

Does Aurlumyn have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Aurlumyn's active ingredient (Iloprost).

When do Aurlumyn's patents expire?

The FDA Orange Book lists 2 patents against Aurlumyn, with the last listed patent expiring Jul 18, 2044. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

Does Aurlumyn have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Aurlumyn. Exclusivity can delay generic approval independently of any listed patents.

What is Aurlumyn's FDA application number?

Aurlumyn is approved under NDA 217933, held by Btg Intl.

Orange Book product · Brand (NDA)

Aurlumyn

Iloprost

Brand (NDA)NDA 217933RLD Btg Intl

Approved

Feb 13, 2024

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aurlumyn (Iloprost) is Btg Intl's brand-name drug, approved by the FDA under NDA 217933 in 2024. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 2 patents against it, the last expiring 2044. 2 marketing-exclusivity periods are recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Feb 13, 2024
2 yr 5 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 13, 2027
in 7 mo
Exclusivity ends · ODE-465
Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 8 mo
Patent 12409184 expires
Listed drug product patent expiration.
Aug 06, 2041
in 15 yr 4 mo
Patent 12409183 expires
Listed method-of-use patent (U-4263) expiration.
Jul 18, 2044
in 18 yr 3 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

ILOPROST

Strength

100MCG/ML (100MCG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 217933

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

VentavisBrand (NDA)
NDA 021779 · Actelion
2005

View full Iloprost family

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

NPNew product exclusivity (3 years)
Feb 13, 2027
in 7 mo
ODE-465Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 8 mo

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12409184	Aug 06, 2041	in 15 yr 4 mo	Product
12409183	Jul 18, 2044	in 18 yr 3 mo	U-4263

Aurlumyn — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Iloprost active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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