Viewing data from:

HEMADY

NDA

DEXAMETHASONE | N211379 | DEXCEL PHARMA TECHNOLOGIES LTD

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

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2033

2034

2035

2036

2037

2038

Today

10537585

Dec. 18, 2037

11304961

Dec. 18, 2037

ODE-271

Oct. 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

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 Hemady (2023)

Total Spending

$159K

Total Claims

657

Beneficiaries

303

Avg Cost/Unit

$28.43

Spending Trend

$2K(2020)→$68K(2021)→$134K(2022)→$159K(2023)

YoY Change:+4.6%

5yr CAGR:+3.8%

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

API Supply Chain10 active DMFs18 inactive

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

EUROAPI FRANCEDEXAMETHASONE

DMF 17481971

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE USP MICRONIZED

DMF 45241982

MAHIMA LIFE SCIENCES PRIVATE LTDDEXAMETHASONE USP

DMF 278882013

FARMABIOS SPADEXAMETHASONE USP

DMF 315322017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE BULK API

DMF 348102020

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE SODIUM PHOSPHATE, BULK API

DMF 348112020

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 362702022

SHANDONG SIRUI PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 368942022

SYMBIOTEC PHARMALAB PRIVATE LTDDEXAMETHASONE USP

DMF 381622023

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 409942024

ORGANON INCInactiveDEXAMETHASONE

DMF 5191963

ORGANON INCInactiveDEXAMETHASONE

DMF 5421963

ORGANON INCInactiveDEXAMETHASONE 21-PHOSPHATE

DMF 5821963

SF DURST AND CO INCInactiveDEXAMETHASONE

DMF 10951967

ORGANON INCInactiveDEXAMETHASONE 21-TERTIARY BUTYLACETATE

DMF 13431969

ANTIBIOTICOS SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE BULK

DMF 23781974

ROUSSEL CORPInactiveDEXAMETHASONE SODIUM METASULFOBENZOATE

DMF 27371976

ORGANON INCInactiveDEXAMETHASONE

DMF 28161976

BLASCHIM SPAInactiveDEXAMETHASONE 21 SODIUM PHOSPHATE

DMF 28491977

ANTIBIOTICOS SPAInactiveDEXAMETHASONE 21-SODIUM M-SULFOBENZOATE

DMF 36841980

BLASCHIM SPAInactiveDEXAMETHASONE

DMF 36861980

CYCLO PRODUCTS INCInactiveDEXAMETHASONE

DMF 37331980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE BASE, USP XX

DMF 42851981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE SODIUM PHOSPHATE USP XX

DMF 44971982

DIOSYNTH BVInactiveDEXAMETHASONE MICRO AND NON-MICRO

DMF 49371983

DIOSYNTH BVInactiveDEXAMETHASONE ACETATE MICRO AND NON MICRO

DMF 49441983

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE

DMF 60301985

QUATRUMInactiveDEXAMETHASONE BASE BP/KUSP AS

DMF 62331986

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -6	View Letter (PDF)
Jun 28, 2021	SUPPL -3	View Letter (PDF)
Oct 4, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Oct 3, 2019

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10537585	Dec 18, 2037	—	—	Yes	—	—
11304961	Dec 18, 2037	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-271	Oct 3, 2026	< 1 year