Prednisolone Patent Expiration

Prednisolone was first introduced by Pfizer Laboratories Div Pfizer Inc in its drug Sterane on Approved Prior to Jan 1, 1982. Other drugs containing Prednisolone are Delta-Cortef, Meti-Derm. 45 different companies have introduced drugs containing Prednisolone.


About Veterinary Prednisolone

Prednisolone is used in a drug marketed by 1 company: Lloyd Inc.

Other drugs containing Prednisolone are: Prednistab .

Prednisolone Petitions

Details of Prednisolone's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Felix Pharmaceuticals Pvt. Ltd. Filed
Vétoquinol N.-A., Inc. Approved
Tyler Group, Inc Approved

Prednisolone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Prednisolone:

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
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum LEO Pharma NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) Swedish Orphan Biovitrum NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients Vastra Gotaland Region NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis VivaVision Biotech, Inc NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Abatacept in earLy Onset Polymyalgia Rheumatica: Study ALORS University Hospital, Brest NA COMPLETED
(Jun 1, 2026)
PHASE3
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction Medicines Development for Global Health NA RECRUITING
(Jun 1, 2026)
PHASE2
Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease Royan Institute NA RECRUITING
(Jun 1, 2026)
PHASE1
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia Kriya Therapeutics, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Low- vs High-Dose Sirolimus With Prednisolone for KHE and KMP Yi Ji NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations Centre Hospitalier Universitaire, Amiens NA RECRUITING
(May 1, 2026)
PHASE2
Parasitic Ulcer Treatment Trial Pilot University of California, San Francisco NA COMPLETED
(May 1, 2026)
PHASE2
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid Regeneron Pharmaceuticals NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome GlaxoSmithKline NA NOT YET RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis NS Pharma, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis Imperial College London NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer R-Pharm International, LLC NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa) Ultragenyx Pharmaceutical Inc NA COMPLETED
(Mar 1, 2026)
PHASE3
Proprioceptive Neuromuscular Facilitation vs Conventional Therapy With Ultrasound-Guided Corticosteroid Injections for Subacromial Bursitis University of Catanzaro NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2


Prednisolone Generic API Manufacturers

Several generic applications have been filed for Prednisolone. The first generic version for Prednisolone was by Everylife and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Tp Anda Holdings Llc and was approved on Jun 23, 2025.

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