Gloperba Patent Expiration

Gloperba is a drug owned by Scilex Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2019 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 20, 2037. Details of Gloperba's patents and their expiration are given in the table below.

Patent strength
6
/ 10

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10226423 Colchicine drug-to-drug interactions
Dec, 2037

(11 years from now)

Active
US12274751 Composition and method of the use of colchicine oral liquid
Nov, 2036

(10 years from now)

Active
US10383821 Colchicine drug-to-drug interactions
Nov, 2036

(10 years from now)

Active
US10383820 Colchicine drug-to-drug interactions
Nov, 2036

(10 years from now)

Active
US9907751 Composition and method of use of colchicine oral liquid
Nov, 2036

(10 years from now)

Active
US12514819 Colchicine Drug-To-Drug Interactions
Nov, 2036

(10 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gloperba's patents.

Given below is the list of recent legal activities going on the following patents of Gloperba.

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 13 Jan, 2026 US12514819
Email Notification 06 Jan, 2026 US12514819
Mail Patent eGrant Notification 06 Jan, 2026 US12514819
Patent eGrant Notification 06 Jan, 2026 US12514819
Recordation of Patent eGrant 06 Jan, 2026 US12514819
Patent Issue Date Used in PTA Calculation 06 Jan, 2026 US12514819
Email Notification 25 Dec, 2025 US12514819
Issue Notification Mailed 23 Dec, 2025 US12514819
Dispatch to FDC 03 Dec, 2025 US12514819
Application Is Considered Ready for Issue 03 Dec, 2025 US12514819

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US patents provide insights into the exclusivity only within the United States, but Gloperba is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gloperba's family patents as well as insights into ongoing legal events on those patents.

Gloperba's Family Patents

Gloperba has patent protection in a total of 2 countries. It has a significant patent presence in the US with 91.7% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Gloperba.

Family Patents

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Clinical Trials

Recent Clinical Trials on Gloperba:

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
Colchicine Effect on Amyotrophic Lateral Sclerosis Patients Azienda Ospedaliero-Universitaria di Modena NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Colchicine and Inflammation in Aortic Stenosis Radboud University Medical Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage Population Health Research Institute NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Tan Tock Seng Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
Colchicine Use in Intracranial Atherosclerotic Disease Chinese University of Hong Kong NA RECRUITING
(Jul 1, 2026)
PHASE2
Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes Asger Lund, MD NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) Hamilton Health Sciences Corporation NA COMPLETED
(Jul 1, 2026)
PHASE2
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial) Ottawa Hospital Research Institute NA RECRUITING
(Jul 1, 2026)
PHASE3
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL The George Institute NA RECRUITING
(Jul 1, 2026)
PHASE3
Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment Brigham and Women's Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis Duke University NA RECRUITING
(Jul 1, 2026)
PHASE3
Colchicine in Chronic Limb-Threatening Ischemia Shin Kong Wu Ho-Su Memorial Hospital NA RECRUITING
(Jul 1, 2026)
PHASE3
Colchicine for Autoimmune and Subacute Thyroiditis Mansoura University NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Colchicine for the Prevention of Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Strategy-Stratified, Randomized, Double-Blind, Placebo-Controlled Trial National Taiwan University Hospital NA ENROLLING BY INVITATION
(Jul 1, 2026)
PHASE2, PHASE3
Colchicine to Reduce Coronary Artery Inflammation in People With HIV Instituto de Investigación Hospital Universitario La Paz NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
RegoNivo vs Standard of Care Chemotherapy in AGOC Australasian Gastro-Intestinal Trials Group NA COMPLETED
(Jun 1, 2026)
PHASE3
Transition to KPL-387 Monotherapy Dosing & Administration Study Kiniksa Pharmaceuticals International, plc NA RECRUITING
(Jun 1, 2026)
PHASE2
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD University of Texas Southwestern Medical Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Study to Evaluate the Safety of Colchicine Rutgers, The State University of New Jersey NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis Lille Catholic University NA COMPLETED
(Apr 1, 2026)
PHASE3
Canadian Study of Arterial Inflammation in Patients With Diabetes and Vascular Events: EvaluatioN of Colchicine Ottawa Heart Institute Research Corporation NA COMPLETED
(Apr 1, 2026)
PHASE3
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine Niguarda Hospital NA RECRUITING
(Apr 1, 2026)
PHASE3
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study Virginia Commonwealth University NA RECRUITING
(Apr 1, 2026)
PHASE1
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk Population Health Research Institute NA RECRUITING
(Mar 1, 2026)
PHASE3




Generic Launch

Generic Release Date:

Gloperba's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 20, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Gloperba Generic API suppliers:

Colchicine is the generic name for the brand Gloperba. 14 different companies have already filed for the generic of Gloperba, with Ph Health having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gloperba's generic

How can I launch a generic of Gloperba before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Gloperba's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gloperba's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Gloperba -

Strength Submission Date Expiration Date of Last Qualifying Patent 180-Day Status First Applicant Approval Generic Competition Status
25 mg / 5 mL
🔒 Unlock
02 Apr, 2020 20 Dec, 2037 Non-Forfeiture Less


Alternative Brands for Gloperba

Gloperba which is used for preventing gout flares in adults., has several other brand drugs using the same active ingredient (Colchicine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Agepha Pharma Fz
Lodoco
Hikma Intl Pharms
Mitigare
Takeda Pharms Usa
Colcrys


Apart from brand drugs containing the same ingredient, some generics have also been filed for Colchicine, Gloperba's active ingredient. Check the complete list of approved generic manufacturers for Gloperba





About Gloperba

Gloperba is a drug owned by Scilex Pharmaceuticals Inc. It is used for preventing gout flares in adults. Gloperba uses Colchicine as an active ingredient. Gloperba was launched by Scilex in 2019.

Approval Date:

Gloperba was approved by FDA for market use on 30 January, 2019.

Active Ingredient:

Gloperba uses Colchicine as the active ingredient. Check out other Drugs and Companies using Colchicine ingredient

Treatment:

Gloperba is used for preventing gout flares in adults.

Dosage:

Gloperba is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.6MG/5ML SOLUTION Prescription ORAL