Viewing data from:

KLISYRI

NDA

TIRBANIBULIN | N213189 | ALMIRALL LLC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Dec. 28, 2030

Feb. 2, 2029

Dec. 28, 2027

Mar. 12, 2038

Sep. 7, 2038

Mar. 12, 2038

Mar. 12, 2038

D-192

Jun. 7, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Almirall, LLC et al v. Taro Pharmaceuticals, Inc. 1:2025cv00385 6 patentsANDA 220075tirbanibulin	D. Del.	2025-03-28	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis NCT06135415	Phase 3	Completed	Almirall, S.A.	280	2023-12-21 → 2025-11-25

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$839.89

Highest Price

$1219.56

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16110-0391-05KLISYRI 1% OINT	$839.89	Big4	Almirall, LLC	05/14/2030
16110-0391-05KLISYRI 1% OINT	$871.11	FSS	Almirall, LLC	05/14/2030
16110-0391-55KLISYRI 1% OINT,TOP,PKT	$1186.70	Big4	Almirall, LLC	05/14/2030
16110-0391-55KLISYRI 1% OINT,TOP,PKT	$1219.56	FSS	Almirall, LLC	05/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Klisyri (2024)

Total Spending

$3.4M

Total Claims

2,868

Beneficiaries

2,207

Avg Cost/Unit

$224.52

Spending Trend

$1.2M(2021)→$2.1M(2022)→$3.0M(2023)→$3.4M(2024)

YoY Change:+3.5%

5yr CAGR:+4.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLTIRBANIBULIN

DMF 377942022

CHONGQING SINTAHO PHARMACEUTICAL CO LTDTIRBANIBULIN

DMF 390972024

TARO PHARMACEUTICAL INDUSTRIES LTDTIRBANIBULIN

DMF 398372024

INDENA SPATIRBANIBULIN

DMF 400122024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -1	View Letter (PDF)
Jul 2, 2024	SUPPL -3	View Letter (PDF)
Jul 2, 2024	SUPPL -5	View Letter (PDF)
Dec 15, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

7 patents1 exclusivity▴

OINTMENT;TOPICAL | Approved: Dec 14, 2020

Patents (7) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7300931	Dec 28, 2030	—	Yes	Yes	—	—
7851470	Feb 2, 2029	—	Yes	Yes		—
10323001	Dec 28, 2027	—	—	Yes	—	—
10617693	Mar 12, 2038	—	—	—		—
10669236	Sep 7, 2038	—	Yes	Yes	—	—
11497750	Mar 12, 2038	—	—	—		—
12667576Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 12, 2038	—	—	—		—

Exclusivities (1)

Code	Date	Status
D-192	Jun 7, 2027	< 1 year