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Last Updated: December 22, 2024

COLCRYS Drug Patent Profile


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Which patents cover Colcrys, and what generic alternatives are available?

Colcrys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seventeen patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in COLCRYS 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 Colcrys

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

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Drug patent expirations by year for COLCRYS
Drug Prices for COLCRYS

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Drug Sales Revenue Trends for COLCRYS

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Recent Clinical Trials for COLCRYS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU School of MedicinePhase 4
VA Office of Research and DevelopmentPhase 4
Helwan UniversityPhase 3

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Pharmacology for COLCRYS
Paragraph IV (Patent) Challenges for COLCRYS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COLCRYS Tablets colchicine 0.3 mg 022352 1 2019-07-19
COLCRYS Tablets colchicine 0.6 mg 022352 1 2011-12-23

US Patents and Regulatory Information for COLCRYS

COLCRYS is protected by seventeen US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 DISCN Yes No 7,619,004 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 DISCN Yes No 8,415,396 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 DISCN Yes No 7,964,647 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

COLCRYS Market Analysis and Financial Projection Experimental

Colchicine Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction

The colchicine market, particularly highlighted by the drug Colcrys, is experiencing significant growth driven by various factors. This article delves into the market dynamics, financial trajectory, and key drivers influencing the colchicine market.

Global Market Size and Growth

The global colchicine market was valued at USD 1,232 million in 2021 and is projected to reach USD 2,552.84 million by 2030, registering a robust Compound Annual Growth Rate (CAGR) of 8.4% during the forecast period[2][3].

Key Drivers of Market Growth

Several factors are driving the growth of the colchicine market:

Increasing Incidences of Gout and Related Diseases

The rising global incidence of gout, Familial Mediterranean Fever (FMF), and other related diseases such as arthritis are major drivers. Gout, in particular, is a critical case of inflammatory arthritis, and its increasing prevalence is a significant factor enhancing market growth[2][3][4].

Clinical Trials and Therapeutic Alternatives

The increase in clinical trials for colchicine has opened up new therapeutic alternatives for various conditions, including cardiovascular diseases and COVID-19 symptom treatment. This has positively impacted the market by encouraging the development of new medicines[2][3].

Regional Growth

North America accounts for the largest revenue share in the global colchicine market, driven by increasing occurrences of gout and pain-related disorders in the US. The Asia Pacific region is also expected to register a robust CAGR due to increasing research and development activities and a growing geriatric population[2][3].

Market Segmentation

Dosage Formulation Outlook

The solid dosage form of colchicine, including tablets and capsules, dominates the market due to its ease of preparation, stability, and long-term release properties. This segment is expected to continue contributing a major revenue share over the forecast period[3].

Application Outlook

Colchicine is highly effective in preventing Familial Mediterranean Fever (FMF) and the development of amyloidosis, making the FMF segment a substantial contributor to revenue. Acute gout treatment is also a significant application, driving market growth[3][4].

Route of Administration Outlook

The topical segment is expected to register a robust CAGR due to its stability, penetrability, and solvent properties, making it a preferred route of administration for certain conditions[3].

Age Outlook

The geriatric segment is expected to account for a substantial revenue share due to the higher prevalence of gout arthritis among older adults[3].

Sales Channel Outlook

Online pharmacies are gaining popularity due to their ease and convenience, and this segment is expected to register the fastest CAGR. Hospitals and clinics also account for a large revenue share, driven by the increasing number of hospitals in emerging Asian economies[2][3].

Financial Trajectory

Historical Data and Forecast

The global colchicine market has seen significant growth from 2018, when it was valued at USD 553.8 million, to 2021, when it reached USD 1,232 million. It is forecasted to continue this growth trend until 2030[1][4].

Impact of FDA Approval and Market Exclusivity

The FDA approval of Colcrys in 2009 led to a drastic price increase from approximately $0.50 per pill to $5.00 per pill, resulting in a virtual monopoly. This has led to prolonged public spending on colchicine, with Medicaid spending increasing by 2833% due to price increases alone[5].

Public Spending and Price Trends

Public spending on colchicine has grown exponentially, mainly due to ongoing price increases after Colcrys’s approval and market exclusivity. This has limited access to the drug for many patients, highlighting the need for more affordable alternatives[5].

Competitive Landscape

Market Players and Strategic Developments

The competitive landscape of the colchicine market includes various pharmaceutical companies involved in product development, clinical trials, and strategic expansions. The report includes insights on company profiles, strategic developments, product launches, and competitive analysis[2][3].

Regional Analysis

North America

North America dominates the global colchicine market due to the high prevalence of gout and pain-related disorders in the US. The region is expected to continue its dominance over the forecast period[2][3].

Asia Pacific

The Asia Pacific region is expected to register a robust CAGR due to increasing research and development activities, growing geriatric population, and high healthcare expenditure in countries like China and India[2][3][4].

Challenges and Opportunities

Pricing and Accessibility

The high prices of colchicine, particularly after the FDA approval of Colcrys, have been a significant challenge. The entry of independent generics into the market could reduce costs, but this is currently delayed due to patent issues[5].

Research and Development

The increasing number of clinical trials for colchicine presents opportunities for the development of new therapeutic alternatives. This trend is expected to continue, driving market growth and innovation[2][3].

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 are major drivers of market growth.
  • Online pharmacies and hospitals & clinics are key sales channels.
  • North America and Asia Pacific are leading regions in terms of market share and growth.
  • High prices and limited accessibility are significant challenges, while ongoing clinical trials offer opportunities for market expansion.

FAQs

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

The global colchicine market is expected to reach USD 2,552.84 million by 2030[2][3].

What are the main drivers of the colchicine market growth?

The main drivers include increasing incidences of gout, FMF, and other related diseases, as well as the increase in clinical trials for various therapeutic applications[2][3].

Which region dominates the global colchicine market?

North America currently dominates the global colchicine market, driven by the high prevalence of gout and pain-related disorders in the US[2][3].

What is the impact of FDA approval on the pricing of Colcrys?

The FDA approval of Colcrys led to a significant price increase, resulting in a virtual monopoly and high public spending on the drug[5].

How is the online pharmacy segment performing in the colchicine market?

The online pharmacy segment is expected to register the fastest CAGR due to its rising popularity, ease, and convenience[2][3].

Sources:

  1. Reports and Data, "Colchicine Market Size, Share, Trends, Growth & Forecasts To 2030"
  2. Biospace, "Colchicine Market Size 2022-2030: Increasing Clinical Studies Of Colchicine Drugs For Various Applications"
  3. Biospace, "Colchicine Market Growth 2022-2030: Increasing Clinical Studies of Colchicine Drugs for Various Applications"
  4. GlobeNewswire, "Colchicine Market To Reach USD 1.13 Billion By 2026"
  5. JAMA Network, "Prolonged Increases in Public-Payer Spending and Prices After FDA Approval of Colcrys"

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