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Last Updated: December 22, 2024

COLCHICINE Drug Patent Profile


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Which patents cover Colchicine, and when can generic versions of Colchicine launch?

Colchicine is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Endo Operations, Granules, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms. and is included in fifteen NDAs.

The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the colchicine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Colchicine

A generic version of COLCHICINE was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.

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Drug patent expirations by year for COLCHICINE
Drug Prices for COLCHICINE

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Drug Sales Revenue Trends for COLCHICINE

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Recent Clinical Trials for COLCHICINE

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SponsorPhase
University of Texas Southwestern Medical CenterPhase 2
University Hospital, GhentPhase 3
Belgium Health Care Knowledge CentrePhase 3

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Pharmacology for COLCHICINE
Medical Subject Heading (MeSH) Categories for COLCHICINE
Paragraph IV (Patent) Challenges for COLCHICINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GLOPERBA Oral Solution colchicine 0.6 mg/5 mL 210942 1 2020-04-02
COLCRYS Tablets colchicine 0.3 mg 022352 1 2019-07-19
MITIGARE Capsules colchicine 0.6 mg 204820 1 2016-06-10
COLCRYS Tablets colchicine 0.6 mg 022352 1 2011-12-23

US Patents and Regulatory Information for COLCHICINE

COLCHICINE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Annora Pharma COLCHICINE colchicine CAPSULE;ORAL 217620-001 Apr 29, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd COLCHICINE colchicine TABLET;ORAL 215444-001 Jan 6, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Granules COLCHICINE colchicine CAPSULE;ORAL 210757-001 Apr 29, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

COLCHICINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Colchicine

Introduction

Colchicine, a medication long used to treat gout and other inflammatory conditions, is experiencing significant market growth driven by several key factors. This article delves into the current market dynamics, financial trajectory, and future outlook for colchicine.

Global Market Size and Growth

The global colchicine market is projected to reach USD 2,552.84 million by 2030, with a revenue CAGR of 8.4% during the forecast period from 2022 to 2030[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the colchicine market:

Increasing Incidences of Gout

The rising incidence of gout globally is a major driver. Gout affects an estimated 9.2 million people in the United States alone, and this number is increasing annually[2].

Prevalence of Related Diseases

Diseases such as Familial Mediterranean Fever (FMF) and arthritis also contribute to the market growth. Colchicine is highly effective in preventing FMF and the development of amyloidosis, making it a critical part of medical care for these conditions[1][4].

Increase in Clinical Trials

The number of clinical trials for colchicine has increased significantly, exploring its therapeutic potential for various conditions, including cardiovascular diseases and COVID-19 symptom treatment. This has led to the discovery of new therapeutic alternatives and bolstered market growth[1][4].

Market Segmentation

Dosage Formulation

The solid dosage form of colchicine, such as tablets and capsules, accounted for the largest revenue share in 2021 and is expected to continue dominating the market due to its ease of preparation, stability, and suitability for long-term release[1].

Application

The Familial Mediterranean Fever segment is expected to account for a substantial revenue share during the forecast period due to colchicine's efficacy in preventing FMF and amyloidosis[1].

Route of Administration

The topical segment is expected to register a robust revenue CAGR, driven by factors such as stability, penetrability, and solvent properties[1].

Age

The geriatric segment is anticipated to account for a significant revenue share, as older adults are more prone to gout and related conditions[1].

Sales Channel

Online pharmacies are expected to register a robust revenue CAGR due to their ease and convenience, making them increasingly popular among consumers[1][4].

End-User

Hospitals and clinics are expected to account for a substantial revenue share, driven by the increasing number of hospitals in emerging Asian economies[1][4].

Regional Market Analysis

North America

North America accounted for the largest revenue share in the global colchicine market, driven by increasing occurrences of gout and pain-related disorders, as well as the rising prevalence of gout treatments in the US[1][4].

Asia Pacific

The Asia Pacific region is expected to register a robust revenue CAGR, driven by increasing research and development activities and a growing geriatric population, which is expected to boost the incidence of gout[1][4].

New Formulations and Market Opportunities

Gloperba®

The introduction of Gloperba®, the first and only liquid oral version of colchicine, addresses a significant unmet need in the treatment of gout. This formulation is particularly beneficial for patients with comorbid conditions requiring dose adjustments, which accounts for over 70% of gout patients. The U.S. gout treatment market is projected to reach $2.0 billion by 2028, indicating a substantial market opportunity for Gloperba®[2].

Impact of Pricing Policies

Historical Price Increase

A significant price increase in colchicine following FDA approval in 2010 led to a drop in its use by 17% and a subsequent increase in emergency department visits and specialist consultations for gout patients. This highlights the critical impact of pricing policies on drug usage and patient outcomes[5].

Competitive Landscape

Key Players and Strategies

Companies like Scilex Holding Company are well-positioned with experienced commercial and managed care teams, which is crucial for the successful marketing and distribution of new formulations like Gloperba®. The commercial strategy leveraged by Scilex, including its established distribution network, mirrors successful approaches taken with previous products, indicating a robust infrastructure for market penetration[2].

Financial Landscape

Revenue Projections

The global colchicine market's financial trajectory is promising, with projected revenues reaching USD 2,552.84 million by 2030. The introduction of new formulations and the increasing prevalence of gout and related diseases are expected to drive this growth[1][4].

Market Opportunities

The non-opioid pain management market, particularly for gout treatment, presents a significant revenue stream. Novel formulations like Gloperba® can command a premium, especially in addressing gastrointestinal side effects and offering flexible dosing options[2].

Key Takeaways

  • The global colchicine market is expected to reach USD 2,552.84 million by 2030 with a CAGR of 8.4%.
  • Increasing incidences of gout and related diseases, along with increased clinical trials, are driving market growth.
  • New formulations like Gloperba® are addressing unmet needs and offering significant market opportunities.
  • Pricing policies can significantly impact drug usage and patient outcomes.
  • The Asia Pacific and North America regions are expected to be key drivers of market growth.

FAQs

What is the projected global market size for colchicine by 2030?

The global colchicine market is expected to reach USD 2,552.84 million by 2030[1][4].

What are the main drivers of the colchicine market growth?

The main drivers include increasing incidences of gout, prevalence of related diseases like FMF and arthritis, and an increase in clinical trials exploring new therapeutic applications[1][4].

What is the significance of Gloperba® in the colchicine market?

Gloperba® is the first and only liquid oral version of colchicine, catering to a significant market opportunity in the U.S. gout treatment market projected to reach $2.0 billion by 2028. It addresses the need for precision dosing, especially for patients with comorbid conditions[2].

How did the price increase of colchicine in 2010 affect its usage?

The price increase led to a 17% drop in colchicine usage and a subsequent increase in emergency department visits and specialist consultations for gout patients, indicating worse disease control[5].

Which regions are expected to drive the growth of the colchicine market?

North America and the Asia Pacific region are expected to be key drivers of market growth due to increasing occurrences of gout and growing geriatric populations[1][4].

Sources

  1. Biospace: Colchicine Market Growth 2022-2030: Increasing Clinical Studies of Colchicine Drugs for Various Applications.
  2. Stocktitan: Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal a High Degree of Interest in Gloperba®.
  3. River Country News Channel Nebraska: Colchicine Market Dynamics till 2032 | Growth Drivers, Market Constraints and Challenges.
  4. Biospace: Colchicine Market Size 2022-2030- Increasing Clinical Studies Of Colchicine Drugs For Various Applications.
  5. UCLA Health: A sharp increase in the price of the gout drug colchicine led to lower use and worse disease control.

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