Hydrocortisone Patent Expiration

Hydrocortisone is Used for treating adrenal insufficiency. It was first introduced by Merck And Co Inc in its drug Hydrocortone on Approved Prior to Jan 1, 1982. Other drugs containing Hydrocortisone are Hydrocortisone, Cortef, Khindivi, Cort-Dome, Cortril, Alkindi Sprinkle, Cortenema. 81 different companies have introduced drugs containing Hydrocortisone.


Hydrocortisone Patents

Given below is the list of patents protecting Hydrocortisone, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Khindivi US11904046 Feb 23, 2043 Eton
Khindivi US12133914 Hydrocortisone Oral Liquid Formulations Feb 23, 2043 Eton
Alkindi Sprinkle US9649280 Composition comprising hydrocortisone May 12, 2034 Eton
Alkindi Sprinkle US9675559 Treatment of adrenal insufficiency Jan 10, 2033 Eton
Alkindi Sprinkle US9717740 Treatment of adrenal insufficiency Nov 19, 2032 Eton



About Veterinary Hydrocortisone

Hydrocortisone has petitions filed by 1 petitioner: Akorn Animal Health Inc.

Hydrocortisone Petitions

Details of Hydrocortisone's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Akorn Animal Health Inc. Approved

Hydrocortisone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Hydrocortisone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Neurocrine UK Limited NA COMPLETED
(Sep 1, 2026)
PHASE1
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations Neurocrine UK Limited NA COMPLETED
(Sep 1, 2026)
PHASE1
Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency Neurocrine UK Limited NA COMPLETED
(Sep 1, 2026)
PHASE2
Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial Assistance Publique - Hôpitaux de Paris NA RECRUITING
(Aug 1, 2026)
PHASE2
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy University of Illinois at Chicago NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia University Hospital, Tours NA WITHDRAWN
(Jun 1, 2026)
PHASE3
Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery Centre Hospitalier Universitaire, Amiens NA RECRUITING
(Jun 1, 2026)
PHASE3
Corticosteroids for Post-Extubation Dysphagia University of Colorado, Denver NA RECRUITING
(May 1, 2026)
PHASE2
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis University of Virginia NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NA COMPLETED
(Apr 16, 2026)
PHASE2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer Weill Medical College of Cornell University NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2


Hydrocortisone Generic API Manufacturers

Several generic applications have been filed for Hydrocortisone. The first generic version for Hydrocortisone was by Teva Pharmaceuticals Usa Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Rising Pharma Holdings Inc and was approved on Jul 16, 2026.

Given below is the list of companies who have filed for Hydrocortisone generic, along with the locations of their manufacturing plants worldwide.