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TACLONEX

NDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | N021852 | LEO PHARMA AS

1 strength0 unique patents0 unique exclusivities

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 Taclonex (2023)

Total Spending

$665K

Total Claims

376

Beneficiaries

138

Avg Cost/Unit

$20.52

Spending Trend

$5.9M(2019)→$2.2M(2020)→$1.1M(2021)→$652K(2022)→$665K(2023)

YoY Change:+6.1%

5yr CAGR:+4.0%

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
Dec 31, 2018	SUPPL -20	View Letter (PDF)
Dec 30, 2014	SUPPL -15	View Letter (PDF)
Jul 29, 2014	SUPPL -16	View Letter (PDF)
Dec 4, 2012	SUPPL -12	View Letter (PDF)
Apr 2, 2010	SUPPL -6	View Letter (PDF)
Oct 4, 2007	SUPPL -2	View Letter (PDF)
Jan 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

RLDAB

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Jan 9, 2006

No patent or exclusivity listings for this strength.