Viewing data from:

ENSTILAR

NDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | N207589 | LEO PHARMA AS

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

Today

Dec. 10, 2031

Jun. 10, 2031

Dec. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Enstilar (2023)

Total Spending

$8.1M

Total Claims

4,633

Beneficiaries

2,053

Avg Cost/Unit

$22.47

Spending Trend

$5.8M(2019)→$6.7M(2020)→$8.3M(2021)→$8.3M(2022)→$8.1M(2023)

YoY Change:+6.9%

5yr CAGR:+6.2%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 10, 2021	SUPPL -11	View Letter (PDF)
Oct 20, 2020	SUPPL -10	View Letter (PDF)
Jul 31, 2019	SUPPL -7	View Letter (PDF)
Jul 31, 2019	SUPPL -6	View Letter (PDF)
Jul 31, 2019	SUPPL -5	View Letter (PDF)
Mar 10, 2016	SUPPL -1	View Letter (PDF)
Oct 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

RLD

8 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Oct 16, 2015

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9119781	Jun 10, 2031PED: Dec 10, 2031	PED	—	Yes		—
9566286	Jun 10, 2031	—	—	Yes	—	—
10130640	Jun 10, 2031PED: Dec 10, 2031	PED	—	Yes	—	—
10617698	Jun 10, 2031	—	—	Yes	—	—
10660908	Jun 10, 2031	—	—	Yes		—
10682364	Jun 10, 2031	—	—	Yes	—	—
10688108	Jun 10, 2031	—	—	—		—
10716799	Jun 10, 2031	—	—	Yes	—	—