Colchicine - Generic Drug Details

What are the generic drug sources for colchicine and what is the scope of freedom to operate?

Colchicine is the generic ingredient in ten branded drugs marketed by Annora Pharma, Aurobindo Pharma Ltd, Endo Operations, Granules, Hikma Intl Pharms, Scilex Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Agepha Pharma Fz, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, Sandoz, and Lederle, and is included in thirty NDAs. There are thirty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has eighty-three patent family members in twenty-five countries.

There are sixteen drug master file entries for colchicine. Thirty-four suppliers are listed for this compound.

Summary for colchicine

International Patents:	83
US Patents:	36
Tradenames:	10
Applicants:	25
NDAs:	30
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	261
Patent Applications:	6,739
Drug Prices:	Drug price trends for colchicine
Drug Sales Revenues:	Drug sales revenues for colchicine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for colchicine
What excipients (inactive ingredients) are in colchicine?	colchicine excipients list
DailyMed Link:	colchicine at DailyMed

See drug prices for colchicine

See drug sales revenues for colchicine

Recent Clinical Trials for colchicine

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 2
AZ Sint-Jan AV	Phase 3
University Hospital, Ghent	Phase 3

See all colchicine clinical trials

Pharmacology for colchicine

Drug Class	Alkaloid
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Medical Subject Heading (MeSH) Categories for colchicine

Gout Suppressants

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for colchicine

M04AC	Preparations with no effect on uric acid metabolism
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	COLCHICINE	colchicine	TABLET;ORAL	204711-001	Sep 28, 2016	AB	RX	No	No
Alkem Labs Ltd	COLCHICINE	colchicine	TABLET;ORAL	211250-001	Feb 8, 2019	AB	RX	No	No
Granules	COLCHICINE	colchicine	CAPSULE;ORAL	210757-001	Apr 29, 2024	AB	RX	No	No
Mylan	COLCHICINE	colchicine	TABLET;ORAL	209470-001	Sep 16, 2019		DISCN	No	No
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes	10,226,423		Y
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,964,648
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,619,004

International Patents for colchicine

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201501024	СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОЛХИЦИН, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Mexico	2020009511	TRATAMIENTO O PREVENCIÓN DE EVENTOS CARDIOVASCULARES. (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE.)
Eurasian Patent Organization	039635	ЛЕЧЕНИЕ ИЛИ ПРОФИЛАКТИКА СЕРДЕЧНО-СОСУДИСТЫХ ЯВЛЕНИЙ С ИСПОЛЬЗОВАНИЕМ ПРОИЗВОДНОГО КОЛХИЦИНА (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS USING A COLCHICINE DERIVATIVE)
World Intellectual Property Organization (WIPO)	2014066944
European Patent Office	2914255	TRAITEMENT OU PRÉVENTION D'ÉVÉNEMENTS CARDIOVASCULAIRES PAR ADMINISTRATION D'UN DÉRIVÉ DE COLCHICINE (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE)
Eurasian Patent Organization	037375	СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОЛХИЦИН, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING SAME)
Israel	242001	פורמולציות של קולציסין עם שחרור מושהה ושיטות לשימוש בהן (Sustained-release formulations of colchicine and methods of using same)

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.