Methylprednisolone Patent Expiration

Methylprednisolone was first introduced by Pfizer Inc in its drug Medrol on Approved Prior to Jan 1, 1982. 15 different companies have introduced drugs containing Methylprednisolone.


About Veterinary Methylprednisolone

Methylprednisolone is used in drugs marketed by 2 different companies: Cronus Pharma Specialities India Private Ltd, Zoetis Inc.

Other drugs containing Methylprednisolone are: Methylprednisolene tablets , Medrol tablets .

Methylprednisolone's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Methylprednisolone:

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
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA TERMINATED
(Sep 1, 2026)
PHASE2
Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA TERMINATED
(Sep 1, 2026)
PHASE2
Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen National Institute of Allergy and Infectious Diseases (NIAID) NA TERMINATED
(Sep 1, 2026)
PHASE2
Study to Evaluate the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee Pacira Pharmaceuticals, Inc NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
VIBRANT: VIB4920 for Active Lupus Nephritis National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 1, 2026)
PHASE2
Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators Astellas Gene Therapies NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease Bin Gu NA RECRUITING
(Sep 1, 2026)
PHASE2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS Vector Y Therapeutics NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
JH013 Injection in Patients With Primary Sjögren's Syndrome Biotech Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis Rigshospitalet, Denmark NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
TReatment for ImmUne Mediated PathopHysiology National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients University of Sydney NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee Pacira Pharmaceuticals, Inc NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors BeOne Medicines NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock Brigham and Women's Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research Oculis NA RECRUITING
(Aug 1, 2026)
PHASE3
Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease Banu Aji Dibyasakti NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients University of California, San Diego NA COMPLETED
(Jul 1, 2026)
PHASE1
A Study of Methylprednisolone in People Having Liver Surgery Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE3
Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis DuoGenic StemCells Corporation (DGSC) NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
CD19-B Cell Depletion in PAIS-ME/CFS Patients Charite University, Berlin, Germany NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Severe Hepatitis Intervention With Emapalumab for Liver Disease Children's Healthcare of Atlanta NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques National Institute of Neurological Disorders and Stroke (NINDS) NA RECRUITING
(May 8, 2026)
PHASE2
Adjunctive Gypenosides for Acute Optic Neuritis First Affiliated Hospital of Guangxi Medical University NA TERMINATED
(May 1, 2026)
PHASE2
IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 University of Cambridge NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Study to Evaluate the Tolerability, Safety and Efficacy of VGM-R02b Shanghai Vitalgen BioPharma Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE1
Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Disease Daihong Liu NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy Sun Yat-sen University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) Charite University, Berlin, Germany NA TERMINATED
(Apr 1, 2026)
PHASE2
REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE) The Hospital for Sick Children NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Oral Steroid Taper After Total Knee Arthroplasty Columbia University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids Masonic Cancer Center, University of Minnesota NA TERMINATED
(Mar 1, 2026)
PHASE1, PHASE2
MAGIC Ruxolitinib for aGVHD John Levine NA RECRUITING
(Mar 1, 2026)
PHASE2
Gene Replacement Therapy for Treatment of Paediatric Patients With CTNNB1 Neurodevelopmental Syndrome CTNNB1 Foundation NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Prehospital Pulse-dose Glucocorticoid in Patients With ST-segment Elevation Myocardial Infarction 2 - The PULSE-MI 2 Trial Thomas Engstrom NA RECRUITING
(Mar 1, 2026)
PHASE3
Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease) Daihong Liu NA RECRUITING
(Mar 1, 2026)
PHASE2


Methylprednisolone Generic API Manufacturers

Several generic applications have been filed for Methylprednisolone. The first generic version for Methylprednisolone was by Heather Drug Co Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Amneal Eu Ltd and was approved on Sep 21, 2021.

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