Details for Patent: 11,026,901

Which drugs does patent 11,026,901 protect, and when does it expire?

Patent 11,026,901 protects LODOCO and is included in one NDA.

This patent has forty-three patent family members in twenty-four countries.

Summary for Patent: 11,026,901

Title:	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Abstract:	A method for the treatment or prevention of a cardiovascular event in a subject with atherosclerotic vascular disease comprising the step of: b) administering a therapeutically effective amount of a compound of formula (I), a known colchicine derivative and/or a salt thereof wherein: R1, R2, R3, R4, R9, R10, R11 and R12 independently represent hydrogen, C1-4 alkyl, C2-4 alkenyl, C3-6 cycloalkyl, halogen, C1-4 haloalkyl, nitro, amino, C2-4 acylamino, C1-4 alkyl or dialkylamino, hydroxyl, C1-4 alkoxy, C1-4 alkylthio, a group of the formula —SO2N(Rx)2 or SO2Rx where Rx is C1-4 alkyl, C1-4 acyloxy, or optionally substituted phenyl, optionally substituted phenoxy; R7 and R8 independently represent hydrogen, C1-4 alkyl or C1-4 acyl; and R5′, R5″, R6′ and R6″ independently represent hydrogen, C1-4 alkyl, C2-4 alkenyl, C3-6 cycloalkyl, halogen, C1-4 haloalkyl, nitro, amino, C2-4 acylamino, hydroxyl, C1-4 alkoxy or C1-4 alkylthio a group of the formula —SO2N(Rx)2 or SO2Rx where Rx is C1-4 alkyl, C1-4 acyloxy, or optionally substituted phenyl.
Inventor(s):	Mark Nidorf
Assignee:	Murray and Poole Enterprises Ltd
Application Number:	US17/103,683
Patent Claim Types: see list of patent claims

United States Patent 11,026,901: A Detailed Analysis of Scope and Claims

Overview of the Patent

The United States Patent 11,026,901, titled "Treatment or Prevention of Cardiovascular Events via the Administration of a Colchicine Derivative," was issued on June 8, 2021. This patent is part of a series of inventions related to the use of colchicine and its derivatives for cardiovascular health.

Inventor and Ownership

The patent names Mark Nidorf as the sole inventor. Murray & Poole Enterprises, Ltd. (M&P) is the exclusive owner of all rights, title, and interest in this patent, having acquired it through assignment[2].

Scope of the Patent

Purpose and Application

The patent is directed towards methods and compositions for the treatment or prevention of cardiovascular events, particularly in subjects with atherosclerotic vascular disease or stable coronary disease. It involves the administration of a colchicine derivative or its salt in a therapeutically effective amount[1][2].

Composition Details

The composition typically includes a colchicine derivative or its salt, along with one or more pharmaceutically acceptable additives, excipients, carriers, and/or diluents. The medicament can contain between 0.01 and 1 mg of the colchicine derivative, with preferred doses being 0.5 mg or 0.6 mg[1].

Administration Method

The composition is administered orally and once per day. This method is particularly beneficial for subjects with clinically stable coronary disease[2].

Claims of the Patent

Primary Claims

• The patent claims a method for treating and/or reducing the risk of cardiovascular events by administering a therapeutically effective amount of a colchicine derivative or its salt.
• It also claims a composition comprising the colchicine derivative or its salt, along with other pharmaceutically acceptable components[1][2].

Specific Claims

• The method includes administering the colchicine derivative or its salt to a subject with atherosclerotic vascular disease or stable coronary disease.
• The patent also covers the co-administration of a second agent, such as a statin or an anti-platelet agent, for enhanced therapeutic effect[1].

Patent Landscape

Related Patents

The patent is part of a broader portfolio that includes other patents related to the use of colchicine derivatives for cardiovascular health. Other relevant patents include U.S. Patent Nos. 10,206,891, 10,265,281, 11,026,899, and 11,026,900, all of which are involved in similar methods and compositions[2].

Patent Expiration

The patents related to the use of colchicine derivatives for cardiovascular events are set to expire around November 2033, providing a significant period of exclusivity for the patent holders[5].

Litigation

There is ongoing litigation related to the infringement of these patents, with Murray & Poole Enterprises, Ltd. alleging that Cigna Group and its affiliates have willfully infringed on these patents by inducing doctors to administer colchicine (e.g., MITIGARE®) to patients for treating atherosclerotic diseases[2].

Clinical and Therapeutic Implications

Mechanism of Action

Colchicine, the primary active ingredient, works by inhibiting the tubulin beta chain, which is involved in the formation of microtubules. This mechanism is crucial in reducing inflammation and preventing cardiovascular events[4].

Clinical Trials and Approval

Colchicine and its derivatives have been subject to numerous clinical trials across various phases. The FDA has approved colchicine for treating gout and Familial Mediterranean Fever, and its use in preventing major cardiovascular events is supported by clinical evidence[4].

Key Takeaways

• Therapeutic Use: The patent covers the use of colchicine derivatives for treating and preventing cardiovascular events.
• Composition: The medicament includes a specific dose of a colchicine derivative or its salt, along with other pharmaceutically acceptable components.
• Administration: Oral administration once daily is the recommended method.
• Patent Landscape: The patent is part of a broader portfolio with related patents expiring around November 2033.
• Litigation: Ongoing litigation involves allegations of patent infringement by healthcare providers.

FAQs

What is the primary use of the colchicine derivative in U.S. Patent 11,026,901?

The primary use is for the treatment or prevention of cardiovascular events in subjects with atherosclerotic vascular disease or stable coronary disease.

How is the colchicine derivative administered according to the patent?

The composition is administered orally once per day.

What are the typical doses of the colchicine derivative mentioned in the patent?

The preferred doses are 0.5 mg or 0.6 mg of the colchicine derivative or its salt.

Are there any other agents that can be co-administered with the colchicine derivative?

Yes, the patent includes the co-administration of a second agent, such as a statin or an anti-platelet agent.

When are the patents related to this invention set to expire?

The related patents are set to expire around November 2033.

Sources

1. US10265281B2 - Treatment or prevention of cardiovascular events via the administration of a colchicine derivative - Google Patents.
2. IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION - Insight.RPXCorp.
3. Patent Claims and Patent Scope - SSRN.
4. Colchicine: Uses, Interactions, Mechanism of Action - DrugBank Online.
5. Lodoco patent expiration - Pharsight.

Drugs Protected by US Patent 11,026,901

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes						A METHOD FOR TREATING AND/OR REDUCING THE RISK OF ACUTE MYOCARDIAL INFARCTION

International Family Members for US Patent 11,026,901

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013337605
Australia	2018203715
Australia	2019232879
Australia	2021282491
Australia	2024205084