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HYDROCORTONE

NDA

HYDROCORTISONE | N008506 | MERCK AND CO INC

2 strengths0 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

8 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response NCT05621850	N/A	Active	University Hospital, Limoges	78	2025-07-25 → 2026-12-05
Carrot Technique Versus Guided Bone Regeneration for Horizontal Ridge Deficiency in the Maxillary Esthetic Zone NCT07670559	N/A	Active	Mansoura University	20	2025-08-02 → 2026-10
The Effects Of Prenatal Health Education On Birth Preparedness And Complication Readiness Among Pregnant Women NCT07666945	N/A	Recruiting	Bule Hora University	576	2026-05-01 → 2026-10-30
Evaluation of OMEGA-3 Effect in Alveolar Socket Preservation in Aesthetic Zone NCT07665918	N/A	Completed	Cairo University	10	2025-01-01 → 2025-10-25
Effect of Isometric Neck Exercises on Cervicogenic Headache Symptoms, Cortisol and BDNF Levels Among Smart Phone Users NCT07354776	N/A	Completed	Khyber Medical University Peshawar	44	2025-06-01 → 2026-03-01
IL-6 and Cortisol Responses to Cycling Exercise NCT07681362	N/A	Completed	Ondokuz Mayıs University	27	2025-05-05 → 2025-06-05
The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy NCT06998121	N/A	Completed	Mersin University	84	2025-12-01 → 2026-04-15
Descriptive Study of Biological Stress and Perceived Stress at the Center 15 NCT02075424	N/A	Completed	Centre Hospitalier Régional Metz-Thionville	40	2014-03 → 2016-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Hydrocortisone* (2023)

Total Spending

$47.5M

Total Claims

2,361,135

Beneficiaries

1,257,661

Avg Cost/Unit

$0.35

Spending Trend

$57K(2019)→$13.8M(2019)→$4.9M(2019)→$4K(2019)→$2.0M(2019)→$29.5M(2019)→$8.1M(2020)→$37K(2020)→$34.0M(2020)→$3.2M(2020)→$3K(2020)→$2.9M(2020)→$24K(2021)→$44.9M(2021)→$6.7M(2021)→$1K(2021)→$2.4M(2021)→$4.2M(2021)→$3.6M(2022)→$28K(2022)→$44.5M(2022)→$6.4M(2022)→$2K(2022)→$2.1M(2022)→$38K(2023)→$2.8M(2023)→$1.0M(2023)→$534.48(2023)→$6.2M(2023)→$47.5M(2023)

YoY Change:-0.3%

5yr CAGR:+3.6%

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

API Supply Chain23 active DMFs21 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCHYDROCORTISONE MICRONIZED AND NON-MICRONIZED

DMF 14131969

EUROAPI FRANCEHYDROCORTISONE USP

DMF 27891976

EUROAPI FRANCEHYDROCORTISONE VALERATE USP BULK SUBSTANCE

DMF 46621982

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCHYDROCORTISONE ACETATE USP, MICRO & NON-MICRO

DMF 54981984

TARO PHARMACEUTICAL INDUSTRIES LTDHYDROCORTISONE 17-VALERATE, USP

DMF 139211998

TARO PHARMACEUTICAL INDUSTRIES LTDHYDROCORTISONE 17-BUTYRATE USP, MICRONIZED

DMF 157502001

HIKMA PHARMACEUTICALSHYDROCORTISONE USP

DMF 160892002

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE BASE

DMF 197342006

CURIA SPAIN SAUHYDROCORTISONE BUTYRATE, MICRONIZED

DMF 218412008

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE USP

DMF 280662014

SHANGHAI NEW HUALIAN PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 285002014

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE HEMISUCCINATE USP

DMF 292212015

EUROAPI FRANCEHYDROCORTISONE

DMF 303732016

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE USP

DMF 313492017

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE BASE USP BULK API

DMF 322042017

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE USP BULK API

DMF 322432017

CURIA SPAIN SAUHYDROCORTISONE MICRONIZED

DMF 330022018

SHANDONG XINHUA PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 330732018

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 360742021

FARMABIOS SPAHYDROCORTISONE HEMISUCCINATE

DMF 376392023

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE M

DMF 379512023

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE M

DMF 382632023

CURIA SPAIN SAUHYDROCORTISONE HEMISUCCINATE MICRONIZED AND NON-MICRONIZED

DMF 388322023

NEW DRUG INSTITUTEInactiveHYDROCORTISONE

DMF 1991940

GIST-BROCADES NV PHARMACEUTICALSInactiveHYDROCORTISONE BULK

DMF 19971972

ANTIBIOTICOS SPAInactiveHYDROCORTISONE 17-VALERATE

DMF 21851972

SCHERING AGInactiveHYDROCORTISONE HEMISUCCINATE

DMF 28891977

SANOFI CHIMIEInactiveHYDROCORTISONE HEMISUCCINATE

DMF 29001977

ANTIBIOTICOS SPAInactiveHYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE

DMF 30971978

DIOSYNTH INCInactiveHYDROCORTISONE MICRONIZED

DMF 39171980

DIOSYNTH BVInactiveHYDROCORTISONE ACETATEMICRO

DMF 39211980

DIOSYNTH BVInactiveHYDROCORTISONE HEMISUCCINATE MICRO

DMF 39611980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHYDROCORTISONE 17-VALERATE (THIS DMF FORMERLY HELD BY S.I.R.S)

DMF 39791980

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE BASE & ACETATE

DMF 47101982

BAYER SCHERING PHARMA AGInactiveHYDROCORTISONE

DMF 47571982

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHYDROCORTISONE HEMISUCCINATE

DMF 61851986

QUATRUMInactiveHYDROCORTISONE HEMISUCCINATE

DMF 66461986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveHYDROCORTISONE HEMISUCCINATE

DMF 67531986

TIANJIN PHARMACEUTICAL PLANTInactiveHYDROCORTISONE

DMF 82691989

TAISHO PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE BUTEPRATE

DMF 83711989

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 116061995

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHYDROCORTISONE BUTYRATE DRUG SUBSTANCE

DMF 181422005

HENAN LIHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 189442005

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 321242017

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

Products (2)

Sort:

#007 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#011 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982