Viewing data from:

CLOBEX

NDA

CLOBETASOL PROPIONATE | N021535 | GALDERMA LABORATORIES L P

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Galderma Laboratories LP et al v. Teligent Inc 3:2015cv03876 1 patentANDA 208667clobetasol propionate	TXND	2015-12-04	Terminated 2016-01-22	—

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 Clobex (2023)

Total Spending

$135K

Total Claims

150

Beneficiaries

Avg Cost/Unit

$7.54

Spending Trend

$758K(2019)→$685K(2020)→$373K(2021)→$148K(2022)→$135K(2023)

YoY Change:+14.1%

5yr CAGR:+22.4%

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

API Supply Chain9 active DMFs4 inactive

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

TAPI NL BVCLOBETASOL PROPIONATE

DMF 68141987

FARMABIOS SPACLOBETASOL PROPIONATE

DMF 83361989

SYMBIOTEC PHARMALAB PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 208212007

HALCYON LABS PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 212162008

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDCLOBETASOL PROPIONATE

DMF 240152010

CURIA SPAIN SAUCLOBETASOL PROPIONATE MICRONIZED

DMF 261912012

ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP

DMF 307522016

RN LABORATORIES EUROPE BVCLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE)

DMF 344852020

NEWCHEM SPACLOBETASOL PROPIONATE

DMF 428922025

CESQUISA SAInactiveCLOBETASOL PROPIONATE

DMF 80961989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCLOBETASOL PROPIONATE

DMF 182022005

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveCLOBETASOL PROPIONATE USP

DMF 226502008

GLAXOSMITHKLINE LLCInactiveCLOBETASOL PROPIONATE

DMF 254442012

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 3, 2012	SUPPL -3	View Letter (PDF)
Aug 20, 2012	SUPPL -2	View Letter (PDF)
Jul 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Jul 24, 2003

No patent or exclusivity listings for this strength.