LODOCO Drug Patent Profile

When do Lodoco patents expire, and when can generic versions of Lodoco launch?

Lodoco is a drug marketed by Agepha Pharma Fz and is included in one NDA. There are ten patents protecting this drug.

This drug has eighty patent family members in twenty-five countries.

The generic ingredient in LODOCO 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 Lodoco

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

Summary for LODOCO

International Patents:	80
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for LODOCO
What excipients (inactive ingredients) are in LODOCO?	LODOCO excipients list
DailyMed Link:	LODOCO at DailyMed

See drug prices for LODOCO

Recent Clinical Trials for LODOCO

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 2
Ottawa Heart Institute Research Corporation	Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 3

See all LODOCO clinical trials

Pharmacology for LODOCO

Drug Class

Alkaloid

US Patents and Regulatory Information for LODOCO

LODOCO is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes

International Patents for LODOCO

See the table below for patents covering LODOCO around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112015026418	formulação de liberação prolongada da colchicina como ingrediente ativo, método para o tratamento e/ou prevenção de uma doença cardiovascular ou uma doença inflamatória em um indivíduo, processo de preparação de um comprimido de liberação prolongada da colchicina e composição terapêutica de liberação prolongada moldada e comprimida compreendendo a colchicina e excipientes combinados em uma matriz
Poland	2914255
Japan	2019065032	コルヒチンの徐放性製剤およびその使用方法 (SUSTAINED-RELEASE FORMULATIONS OF COLCHICINE AND METHODS OF USING THE SAME)
Brazil	112015010063	método para o tratamento ou prevenção de um evento cardiovascular em um sujeito com doença vascular aterosclerótica, utilização de um composto de fórmula (i), um derivado da colquicina conhecido e/ou um sal do mesmo, composição para a prevenção ou tratamento de um evento cardiovascular em um sujeito com doença vascular aterosclerótica, método e regime para reduzir ou prevenir a inflamação induzida por cristal de colesterol no interior das placas ateroscleróticas em um sujeito, regime para o tratamento ou prevenção de um acidente cardiovascular em um indivíduo
Canada	2894417	TRAITEMENT OU PREVENTION D'EVENEMENTS CARDIOVASCULAIRES PAR ADMINISTRATION D'UN DERIVE DE COLCHICINE (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE)

LODOCO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lodoco

Introduction to Lodoco

Lodoco, developed by Agepha Pharma, has made history as the first anti-inflammatory drug approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients. This approval marks a significant milestone in the treatment of atherosclerotic cardiovascular disease (ASCVD)[2][4][5].

Clinical Significance and Mechanism

Lodoco targets the underlying inflammation that contributes to ASCVD. It is a reformulated version of colchicine, a well-established molecule, but at a lower dose suitable for long-term use in cardiovascular disease patients. The drug is administered as a once-daily 0.5 mg tablet and can be used alone or in combination with cholesterol-lowering medications[2][4][5].

Market Need and Potential

The global myocardial infarction market is projected to grow significantly, with a forecasted value of $3.43 billion by 2032, up from $2.02 billion in 2023, at a CAGR of 6.06% from 2024 to 2032. This growth is driven by increasing public awareness campaigns and initiatives to address cardiovascular diseases[3].

Pricing Strategy and Accessibility

One of the critical factors influencing the market dynamics of Lodoco is its pricing strategy. Agepha Pharma has not yet determined the exact price of Lodoco but has emphasized a commitment to ensuring accessibility. The company is developing a patient assistance program to help those who may not be able to afford the medication. This approach is crucial given the historical context of colchicine, which saw a significant price hike in 2010 that led to a decline in its use and poorer disease control[1][2][5].

Historical Pricing Context

The price of colchicine increased dramatically from $11.25 in 2009 to $190.49 in 2011, resulting in reduced usage and increased clinical encounters for gout due to poorer disease control. This historical context underscores the importance of a thoughtful pricing strategy for Lodoco to avoid similar outcomes[1].

Clinical Trial Outcomes

The FDA approval of Lodoco was based on a clinical trial involving 5,522 patients with chronic coronary disease. The trial, published in Circulation in February 2022, showed that Lodoco reduced the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% compared to the placebo group over five years[2][4][5].

Market Impact and Adoption

The approval of Lodoco is expected to significantly impact the cardiovascular disease treatment landscape. By targeting inflammation, a key underlying cause of ASCVD, Lodoco offers a new therapeutic option that can be used in conjunction with existing treatments. This could lead to increased adoption among cardiologists, particularly those focused on preventive cardiology[1][2][5].

Competitive Landscape

The cardiovascular disease market is highly competitive, with various treatments and therapies available. However, Lodoco's unique mechanism of action and its approval as the first anti-inflammatory drug for ASCVD position it as a significant player. The integration of Lodoco into treatment protocols could alter the competitive dynamics, especially as it can be used in combination with other therapies[2][4][5].

Public and Professional Reception

The healthcare industry has welcomed the approval of Lodoco, recognizing its potential to improve patient outcomes. Cardiologists and healthcare professionals are optimistic about the drug's ability to reduce cardiovascular events, and there is a growing interest in raising awareness about cardiovascular inflammation and the role of Lodoco in managing it[1][2][5].

Launch and Availability

Agepha Pharma anticipates that Lodoco will be available for prescription in the second half of 2023. The company is focused on launching the medication and ensuring it reaches high-risk heart patients as quickly as possible[1][2][5].

Financial Projections and Growth

Given the growing demand for effective cardiovascular treatments and the projected growth of the myocardial infarction market, Lodoco is expected to contribute significantly to Agepha Pharma's revenue. The drug's ability to reduce major cardiovascular events by 31% positions it for strong market performance and potential long-term financial success[3].

Challenges and Opportunities

While the approval of Lodoco presents numerous opportunities, there are also challenges to consider. Ensuring affordability and accessibility through the patient assistance program will be crucial. Additionally, educating healthcare providers and patients about the benefits and proper use of Lodoco will be essential for its adoption and success[1][2][5].

Key Takeaways

• Historic Approval: Lodoco is the first FDA-approved anti-inflammatory drug for reducing the risk of myocardial infarction, stroke, and other cardiovascular events.
• Pricing Strategy: Agepha Pharma is focusing on ensuring accessibility through a patient assistance program.
• Clinical Significance: Lodoco targets inflammation, a key underlying cause of ASCVD, and can be used with cholesterol-lowering medications.
• Market Growth: The global myocardial infarction market is projected to grow significantly, driven by increasing awareness and initiatives.
• Launch and Availability: Expected to be available for prescription in the second half of 2023.

FAQs

Q: What is Lodoco, and how does it differ from traditional colchicine? A: Lodoco is a reformulated version of colchicine, specifically designed for long-term use in cardiovascular disease patients at a lower dose (0.5 mg) compared to the high doses used for gout treatment[2][4][5].

Q: What were the key findings of the clinical trial that led to Lodoco's approval? A: The clinical trial showed that Lodoco reduced the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% compared to the placebo group over five years[2][4][5].

Q: How will Agepha Pharma ensure that Lodoco is accessible to patients who cannot afford it? A: Agepha Pharma is developing a patient assistance program to help ensure access to those who may not be able to afford the medication[1][2][5].

Q: What is the projected market value of the global myocardial infarction market by 2032? A: The global myocardial infarction market is forecasted to be around $3.43 billion by 2032, growing at a CAGR of 6.06% from 2024 to 2032[3].

Q: When is Lodoco expected to be available for prescription? A: Lodoco is anticipated to be available for prescription in the second half of 2023[1][2][5].

Cited Sources

1. Cardiovascular Business: "What will Lodoco cost? Looking ahead after FDA's historic approval of colchicine for CVD"[1].
2. Medical Economics: "FDA approves Lodoco, first anti-inflammatory drug for cardiovascular disease"[2].
3. Renub Research: "Myocardial Infarction Market, Forecast 2024-2032"[3].
4. Drug Topics: "First Anti-Inflammatory Drug for Cardiovascular Disease Approved by FDA"[4].
5. Cardiovascular Today: "Agepha Pharma's Lodoco Anti-Inflammatory Drug for Cardiovascular Disease Approved by FDA"[5].