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DIPROLENE

NDA

BETAMETHASONE DIPROPIONATE | N018741 | ORGANON LLC A SUB OF ORGANON AND CO

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Diprolene (2023)

Total Spending

$12K

Total Claims

Beneficiaries

Avg Cost/Unit

$4.40

Spending Trend

$11K(2022)→$12K(2023)

YoY Change:+10.4%

5yr CAGR:+10.4%

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

API Supply Chain9 active DMFs6 inactive

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

TAPI NL BVBETAMETHASONE DIPROPIONATE

DMF 41481981

TARO PHARMACEUTICAL INDUSTRIES LTDBETAMETHASONE DIPROPIONATE USP, MICRONIZED

DMF 146511999

CURIA SPAIN SAUBETAMETHASONE DIPROPIONATE

DMF 170462003

HALCYON LABS PRIVATE LTDBETAMETHASONE DIPROPIONATE USP

DMF 205822007

FARMABIOS SPABETAMETHASONE DIPROPIONATE MICRONIZED

DMF 231182009

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDBETAMETHASONE DIPROPIONATE

DMF 244862010

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE DIPROPIONATE

DMF 257982012

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBETAMETHASONE DIPROPIONATE USP

DMF 352322020

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE DIPROPIONATE

DMF 358532021

GLAXOCHEM LTDInactiveBETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT

DMF 51571983

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE DIPROPIONATE

DMF 67261986

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveBETAMETHASONE DIPROPIONATE

DMF 70951987

QUATRUMInactiveBETAMETHASONE DIPROPIONATE

DMF 71251987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE DIPROPIONATE

DMF 73891988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE DIPROPIONATE USP

DMF 226492008

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
May 2, 2019	SUPPL -40	View Letter (PDF)
Apr 1, 2018	SUPPL -38	View Letter (PDF)
Aug 14, 2014	SUPPL -36	View Letter (PDF)
Sep 18, 2006	SUPPL -28	View Letter (PDF)
Feb 22, 2006	SUPPL -16	View Letter (PDF)
Oct 14, 2005	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.05% BASE

RLDAB

0 patents0 exclusivities▴

OINTMENT, AUGMENTED;TOPICAL | Approved: Jul 27, 1983

No patent or exclusivity listings for this strength.