United States Patent 10,206,891: Scope, Claims, Expiration, and Colchicine Cardiovascular Patent Landscape

U.S. Patent No. 10,206,891 protects methods of using low-dose colchicine to treat or reduce the risk of specified cardiovascular events, particularly when colchicine is used with antiplatelet, anticoagulant, thrombolytic, or statin therapy. The patent is method-of-treatment intellectual property rather than a composition-of-matter patent.

The claims focus on four commercial parameters:

Colchicine dosing of approximately 0.5 mg to 0.75 mg, including the specific 0.6 mg dose.
Once-daily administration.
Treatment of acute coronary syndrome, cardiac arrest, out-of-hospital cardiac arrest, and noncardioembolic ischemic stroke.
Concomitant use with cardiovascular standard-of-care therapies, including aspirin, P2Y12 inhibitors, anticoagulants, thrombolytics, and statins.

The patent was issued February 19, 2019. Public patent records identify a projected expiration date in 2035, subject to any applicable patent-term adjustment, disclaimer, or other term calculation reflected in USPTO records. The patent is listed in connection with colchicine cardiovascular use and is relevant to the U.S. regulatory and generic-entry analysis for low-dose colchicine products. [1]

What does U.S. Patent 10,206,891 protect?

Patent 10,206,891 protects administering colchicine, a colchicine salt, or a combination to a human subject who has experienced, or is at risk of, a defined cardiovascular event.

The broadest independent claim is claim 1. It requires:

Administration of colchicine or a colchicine salt.
A subject at risk of a cardiovascular event or who has already experienced one.
A cardiovascular event defined as:
- acute coronary syndrome;
- out-of-hospital cardiac arrest; or
- noncardioembolic ischemic stroke.

Claim 1 does not require a particular dose, route, dosage form, concomitant medication, formulation technology, or treatment duration. Those limitations appear in dependent claims 2 through 29.

Claim 30 is narrower than claim 1 in some respects because it requires the subject to be receiving an antiplatelet, anticoagulant, or thrombolytic agent. It also requires a colchicine dose of approximately 0.5 mg to 0.75 mg.

Claim 31 is a separate independent claim. It requires:

A human subject.
Colchicine dosing of approximately 0.5 mg to 0.75 mg.
Concurrent administration of an antiplatelet, anticoagulant, thrombolytic agent, or combination.
A cardiovascular event consisting of acute coronary syndrome, cardiac arrest, or noncardioembolic ischemic stroke.
Further definitions for acute myocardial infarction, unstable angina, asystole, ventricular tachycardia, ventricular fibrillation, and exclusion of atrial fibrillation and intracranial hemorrhage as the cause of stroke.

The practical effect is a layered claim structure. Claim 1 is broad as to dose and treatment regimen. Claims 3 through 5 and claims 30 and 31 are more closely aligned with commercial low-dose colchicine products.

How many patents cover low-dose colchicine cardiovascular treatment?

The relevant estate includes patents directed to cardiovascular uses of colchicine, dose regimens, patient populations, and pharmaceutical products. Patent 10,206,891 is one of the most commercially relevant U.S. patents because its claims cover cardiovascular-risk reduction using the low doses associated with modern colchicine products.

Patent or patent family	General subject matter	Commercial relevance
U.S. Patent 10,206,891	Colchicine for cardiovascular events, including acute coronary syndrome, cardiac arrest, and noncardioembolic ischemic stroke	Directly relevant to low-dose cardiovascular colchicine
Earlier Olatec-related cardiovascular-use patents	Colchicine treatment of coronary disease and atherosclerotic cardiovascular disease	May create overlapping or complementary use claims
Product-specific Orange Book patents	Approved colchicine product, formulation, labeling, or approved use	Relevant to ANDA certification and generic launch
Other use patents	Colchicine for inflammatory, vascular, or post-event indications	Relevant only if the proposed product labeling or conduct falls within the claims

Patent-count analysis must distinguish between issued patents, pending continuations, expired patents, and patents listed for a specific FDA-approved product. A patent family can contain several U.S. patents with different claim scope and expiration dates.

When does U.S. Patent 10,206,891 expire?

The reported projected expiration date for U.S. Patent 10,206,891 is June 12, 2035. The effective expiration date must be confirmed against the USPTO patent-term record because patent-term adjustment, terminal disclaimers, disclaimers, or post-issuance corrections can affect the enforceable term. [1]

Event	Date or status
U.S. patent issued	February 19, 2019
Patent number	10,206,891
Reported projected expiration	June 12, 2035
Patent type	Utility patent
Core subject matter	Cardiovascular treatment and risk reduction using colchicine
Relevant regulatory product	Low-dose colchicine cardiovascular products, including Lodoco

The patent term is materially longer than the exclusivity period historically associated with Colcrys and other colchicine products because those products relied on older colchicine development and approval histories. Patent 10,206,891 is therefore more important for low-dose cardiovascular indications than for general colchicine availability.

What are the strongest claims in Patent 10,206,891?

The strongest commercial claims are claims 3, 4, 5, 28, 29, 30, and 31.

Dose claims

Claims 3 through 5 cover:

approximately 0.5 mg to 0.75 mg;
approximately 0.5 mg to 0.6 mg; and
approximately 0.6 mg.

These claims are directed to the dose range used by low-dose colchicine cardiovascular products. A 0.6 mg once-daily product would fall within the literal scope of claims 3 and 5 if the other limitations of claim 1 are satisfied.

Once-daily administration

Claim 2 requires administration once per day. A once-daily 0.5 mg, 0.6 mg, or 0.75 mg regimen used for a claimed cardiovascular population would present a direct claim-mapping risk.

The claim does not require a particular tablet strength. A product administered as two 0.3 mg tablets could potentially satisfy the dose limitation if the total administered amount is approximately 0.6 mg.

Immediate-release formulation

Claim 28 covers an immediate-release colchicine formulation. This claim is important because many conventional colchicine tablets are immediate-release products. It does not require a novel excipient, release-control technology, particle-size distribution, or manufacturing process.

As a result, claim 28 is a use claim tied to a dosage-form characteristic, not a conventional formulation patent in the narrower sense. A generic manufacturer could face infringement risk even if its tablet composition differs from the branded product, provided it is an immediate-release product used according to the claimed cardiovascular regimen.

Two-year treatment duration

Claim 29 requires treatment for at least two years. This limitation may reduce the claim's applicability to short-course use after an acute event, but it increases relevance to chronic secondary prevention in stable coronary disease or atherosclerotic cardiovascular disease.

How do the antiplatelet, anticoagulant, and statin claims operate?

Claims 8 through 19 and claims 23 through 27 extend the patent to combination-treatment settings.

Antiplatelet and anticoagulant combinations

The claims identify a broad range of agents, including:

aspirin;
clopidogrel;
prasugrel;
ticagrelor;
warfarin;
dabigatran;
rivaroxaban;
apixaban;
edoxaban;
heparin;
low-molecular-weight heparin;
alteplase;
tenecteplase; and
other listed antiplatelet, anticoagulant, and thrombolytic agents.

The combination claims are significant because colchicine is commonly evaluated or prescribed alongside background cardiovascular therapy. Claim 30 and claim 31 require concurrent use of one of these therapeutic categories.

A product label that instructs use with aspirin, an anticoagulant, or another antithrombotic could create an induced-infringement issue if the remaining claim elements are met. The analysis would depend on the approved indication, prescribing instructions, promotional conduct, and the precise claim being asserted.

Statin combinations

Claims 17 through 19 and claims 23 through 27 cover colchicine administered with a statin, including atorvastatin, rosuvastatin, simvastatin, pravastatin, and other listed statins.

These claims are narrower than claim 1 because they require an additional therapeutic agent. They may be relevant to standard secondary-prevention regimens in which a patient receives colchicine, aspirin, and a statin.

The presence of a statin limitation does not convert the patent into a statin-combination composition patent. The claimed invention remains a method of treating or reducing cardiovascular risk.

What cardiovascular conditions are covered?

The patent has both broad event-based language and narrower disease-state language.

Claim group	Covered condition
Claims 1, 30, 31	Acute coronary syndrome, cardiac arrest, out-of-hospital cardiac arrest, noncardioembolic ischemic stroke
Claims 20-21	Coronary disease and clinically stable coronary disease
Claims 22-27	Atherosclerotic vascular disease, including coronary disease
Claims 29, 31	Long-term treatment and specified clinical definitions

Claim 31 provides the most detailed disease definitions. It identifies acute coronary syndrome as acute myocardial infarction or unstable angina. It defines cardiac arrest by reference to asystole, ventricular tachycardia, or ventricular fibrillation. It excludes stroke attributable to atrial fibrillation or intracranial hemorrhage.

Those definitions may create both infringement and validity issues. A generic manufacturer or competitor would examine whether the proposed labeling expressly includes the defined conditions or whether the claim requires clinical facts that are not established by the label alone.

Is Patent 10,206,891 a formulation patent or a method-of-use patent?

Patent 10,206,891 is primarily a method-of-use patent.

It does not claim:

a new colchicine molecule;
a new colchicine salt as a composition;
a specific excipient system;
a controlled-release matrix;
a proprietary tablet architecture;
a manufacturing process; or
a new chemical entity.

Claims 6 and 7 identify administration routes and dosage forms, while claim 28 identifies an immediate-release formulation. These limitations narrow the method claims but do not create a standalone formulation monopoly.

The patent's enforceability therefore depends heavily on the use of the product. A non-infringing product strategy may require avoiding the patented cardiovascular indication, avoiding the claimed dose, or avoiding instructions that encourage the claimed combination regimen. Such strategies must also account for FDA labeling rules and induced-infringement doctrine.

What is the Orange Book status of colchicine cardiovascular products?

The FDA Orange Book identifies patents submitted by sponsors for approved drug products. For a low-dose cardiovascular colchicine product such as Lodoco, the relevant patents can affect ANDA filing strategy, Paragraph IV certifications, and the timing of generic approval. [2]

The key distinction is between:

FDA-listed patents for the approved product;
patents that may be enforceable but are not Orange Book-listed;
patents covering a method of use;
patents covering a formulation or dosage form; and
regulatory exclusivity that is separate from patent protection.

FDA approval of a generic colchicine product does not itself eliminate patent liability. An ANDA applicant must address each applicable listed patent through a Paragraph I, II, III, or IV certification, or through a section viii statement where permitted.

What Paragraph IV challenges could affect this patent?

A Paragraph IV certification would assert that the patent is invalid, unenforceable, or will not be infringed by the proposed ANDA product. The principal challenge theories could include:

lack of novelty based on prior colchicine cardiovascular studies;
obviousness based on prior clinical evidence and known low-dose regimens;
inadequate written description for the full cardiovascular-event scope;
lack of enablement for the broad list of cardiovascular events, agents, routes, and dosage forms;
indefiniteness in terms such as "about," "at risk," or "cardiovascular event"; and
noninfringement based on labeling that omits the claimed indication or combination therapy.

The patent's potential vulnerability is concentrated in its breadth. Claim 1 covers multiple event categories without requiring a specific dose or treatment duration. Claim 31 is narrower and more detailed, which may make it easier to defend against certain written-description or enablement attacks, while also creating more opportunities for a noninfringement position.

A Paragraph IV notice would ordinarily trigger Hatch-Waxman litigation if the patent holder files suit within the statutory period. The resulting litigation could delay approval of the ANDA through the statutory stay period, subject to the patent and regulatory circumstances. [3]

Which companies are challenging colchicine cardiovascular patents?

Publicly available information cited here does not establish a specific current Paragraph IV challenger or active district-court case involving U.S. Patent 10,206,891. The principal commercial parties are:

the patent owner or exclusive licensee;
the sponsor of the FDA-approved low-dose cardiovascular colchicine product;
ANDA applicants seeking approval of generic colchicine; and
manufacturers developing alternative colchicine formulations or indications.

The competitive threat is likely to arise from generic applicants that can avoid the patented cardiovascular labeling or challenge the patent through Paragraph IV certification. Because colchicine is an established active ingredient, the principal barrier is usually use-patent and regulatory strategy rather than chemical synthesis.

How strong is the patent estate for low-dose cardiovascular colchicine?

The estate is commercially meaningful but narrower than a composition-of-matter estate.

Strengths

It covers the clinically important 0.5 mg to 0.75 mg range.
It expressly includes the 0.6 mg dose.
It covers chronic cardiovascular-risk reduction.
It includes acute coronary syndrome, cardiac arrest, and noncardioembolic ischemic stroke.
It reaches use with aspirin, antiplatelet agents, anticoagulants, thrombolytics, and statins.
It includes immediate-release formulations.
It has a reported expiration in 2035.

Limitations

It does not prevent manufacture or sale of colchicine for every indication.
It does not claim the colchicine molecule itself.
It may require proof that the patient population and cardiovascular event satisfy specific claim language.
Several claims require concurrent therapy or a treatment duration of at least two years.
Generic labeling design may create noninfringement positions for indications outside the patent.

The estate is strongest where a product is labeled for once-daily 0.5 mg or 0.6 mg colchicine for secondary prevention in patients with coronary or atherosclerotic cardiovascular disease, particularly alongside aspirin or statin therapy.

What generic entry risks exist?

Three generic launch scenarios are most relevant.

Scenario 1: Label carve-out

An ANDA applicant may seek to omit patented cardiovascular uses if the FDA-approved product has non-patented indications that can support approval. This strategy is less effective if the product's commercial value depends primarily on the patented cardiovascular indication.

Scenario 2: Paragraph IV litigation

A generic applicant may challenge validity or infringement and launch after settlement, court victory, or resolution of the statutory stay. The patent holder could seek an injunction or damages based on the scope of the proposed labeling and actual conduct.

Scenario 3: Delayed launch after patent expiry

A generic manufacturer may avoid litigation and wait until the reported 2035 expiration date, although other patents, pediatric exclusivity, regulatory exclusivity, or settlement terms could affect the actual launch date.

How does Patent 10,206,891 compare with colchicine product protection?

Protection type	Typical scope	Relevance to 10,206,891
Composition-of-matter patent	The active molecule or new chemical entity	Not the principal protection here
Formulation patent	Excipients, release profile, particle size, dosage form	Only limited relevance through claims 7 and 28
Method-of-use patent	Administration for a disease or patient population	Core protection
Combination-use patent	Use with another therapeutic agent	Claims 8-19 and 23-27
Manufacturing patent	Process for producing colchicine or tablets	Not claimed in the supplied claims
Regulatory exclusivity	FDA approval-based market protection	Separate from patent rights

Key Takeaways

U.S. Patent 10,206,891 is a cardiovascular method-of-use patent for colchicine.
Its central dose range is approximately 0.5 mg to 0.75 mg, including the commercially important 0.6 mg dose.
Claim 1 is broad and covers colchicine use for acute coronary syndrome, out-of-hospital cardiac arrest, and noncardioembolic ischemic stroke.
Claims 30 and 31 add concurrent antithrombotic therapy and detailed disease definitions.
Claims 17 through 27 cover use with statins and treatment of coronary or atherosclerotic vascular disease.
Claim 28 reaches immediate-release colchicine use, but the patent is not primarily a formulation patent.
The reported projected expiration date is June 12, 2035.
Generic exposure is highest for once-daily low-dose colchicine labeled for cardiovascular secondary prevention with aspirin, antiplatelet agents, anticoagulants, thrombolytics, or statins.
Potential Paragraph IV defenses include obviousness, enablement, written description, indefiniteness, and noninfringement based on labeling.
The patent does not block all colchicine products or all non-cardiovascular uses of colchicine.

FAQs About U.S. Patent 10,206,891

Does a 0.6 mg colchicine tablet fall within the patent claims?

It can. A 0.6 mg dose falls expressly within claim 5 and also within the broader 0.5 mg to 0.75 mg ranges in claims 3 and 30. The cardiovascular indication and other claim limitations must also be satisfied.

Does concurrent aspirin use increase infringement risk?

Yes. Claims 8 through 16, claim 30, and claim 31 expressly address concurrent antiplatelet, anticoagulant, or thrombolytic therapy. Aspirin is specifically identified in claims 12 and 14.

Does the patent cover colchicine for atrial-fibrillation-related stroke?

Claim 31 expressly excludes noncardioembolic stroke attributable to atrial fibrillation. Other claims must be analyzed separately based on their language and the asserted theory of infringement.

Can a generic manufacturer sell colchicine before 2035?

Potentially, depending on the indication, label, patent certifications, litigation outcome, settlement terms, and any other applicable patents or regulatory exclusivities. General colchicine availability does not automatically authorize the patented cardiovascular use.

Is Patent 10,206,891 a patent on Lodoco itself?

It is not a basic composition-of-matter patent on colchicine. It protects specified methods of using colchicine for cardiovascular risk reduction and treatment. Its commercial significance depends on the approved product's labeling and use.

References

United States Patent and Trademark Office. (2019). U.S. Patent No. 10,206,891, methods of treating and/or reducing the risk of cardiovascular events. U.S. Department of Commerce.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2017). Abbreviated new drug application approvals: Patent certifications and exclusivity provisions. U.S. Department of Health and Human Services.

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	10,206,891	⤷ Start Trial				A METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT; ACUTE CORONARY SYNDROME, OUT-OF-HOSPITAL CARDIAC ARREST, AND/OR NONCARDIOEMBOLIC ISCHEMIC STROKE	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013337605	⤷ Start Trial
Australia	2018203715	⤷ Start Trial
Australia	2019232879	⤷ Start Trial
Australia	2021282491	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,206,891

Which drugs does patent 10,206,891 protect, and when does it expire?

Summary for Patent: 10,206,891