Viewing data from:

EUCRISA

NDA

CRISABOROLE | N207695 | ANACOR PHARMACEUTICALS INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (2)Active (2)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

Today

Dec. 29, 2029

Jul. 20, 2030

Aug. 16, 2027

Aug. 16, 2027

D-191

Apr. 3, 2026

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Anacor Pharmaceuticals, LLC, et al., v. Macleods Pharmaceuticals Ltd., et al., 1:2021cv01348 4 patentsANDA 216301crisaborole	D. Del.	2021-09-24	Terminated 2023-08-24	—
Anacor Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals Development, Inc. et al 1:2021cv01353 3 patentsANDA 215914crisaborole	D. Del.	2021-09-24	Terminated 2023-06-15	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Eucrisa (2023)

Total Spending

$10.4M

Total Claims

11,803

Beneficiaries

5,637

Avg Cost/Unit

$12.15

Spending Trend

$16.0M(2019)→$14.1M(2020)→$11.7M(2021)→$10.6M(2022)→$10.4M(2023)

YoY Change:+6.0%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs

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

HONOUR LAB LTDCRISABOROLE

DMF 330602019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCRISABOROLE

DMF 332182018

VIRUPAKSHA ORGANICS LTDCRISABOROLE

DMF 332752018

MSN LIFE SCIENCES PRIVATE LTDCRISABOROLE

DMF 332782018

OLON SPACRISABOROLE

DMF 342342019

MACLEODS PHARMACEUTICALS LTDCRISABOROLE

DMF 345062020

TAPI NL BVCRISABOROLE

DMF 349202020

CHANGZHOU PHARMACEUTICAL FACTORYCRISABOROLE

DMF 373562022

ANHUI POLY PHARM CO LTDCRISABOROLE

DMF 391482023

OPTIMUS DRUGS PRIVATE LTDCRISABOROLE

DMF 397792024

JIANGXI SYNERGY PHARMACEUTICAL CO LTDCRISABOROLE

DMF 400252024

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 4, 2023	SUPPL -12	View Letter (PDF)
Mar 24, 2020	SUPPL -7	View Letter (PDF)
Mar 24, 2020	SUPPL -9	View Letter (PDF)
Mar 24, 2020	SUPPL -10	View Letter (PDF)
Oct 18, 2017	SUPPL -2	View Letter (PDF)
Dec 15, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%

RLD

4 patents1 exclusivity▴

OINTMENT;TOPICAL | Approved: Dec 14, 2016

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8039451	Jun 29, 2029PED: Dec 29, 2029	PED	Yes	Yes	—	—
8168614	Jan 20, 2030PED: Jul 20, 2030	PED	—	—		—
8501712	Feb 16, 2027PED: Aug 16, 2027	PED	—	—		—
9682092	Feb 16, 2027PED: Aug 16, 2027	PED	—	—		—

Exclusivities (1)

Code	Date	Status
D-191	Apr 3, 2026	Expired