Question 1

Is there a generic for Tirbanibulin?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Tirbanibulin. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Tirbanibulin?

Accepted Answer

KLISYRI (NDA 213189, ALMIRALL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tirbanibulin?

Accepted Answer

The Orange Book lists 6 patents against Tirbanibulin products, with the earliest listed expiry in 2027. 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 Tirbanibulin have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Tirbanibulin. 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 Tirbanibulin are approved?

Accepted Answer

Tirbanibulin is approved in the following dosage form: ointment.

Patent	Expires	In	Type
10323001	Dec 28, 2027	in 1 yr 7 mo	Product
7851470	Feb 02, 2029	in 2 yr 8 mo	SubstanceProductU-3015
7300931	Dec 28, 2030	in 4 yr 7 mo	SubstanceProduct
10617693	Mar 12, 2038	in 11 yr 11 mo	U-3015
11497750	Mar 12, 2038	in 11 yr 11 mo	U-3015
10669236	Sep 07, 2038	in 12 yr 5 mo	SubstanceProduct

Tirbanibulin

Brand (NDA) products · ointment

Marketing exclusivity (1)

Listed patents (6)

Tirbanibulin — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.