United States Patent 12,144,792: Acetyl-Leucine Neurodegenerative Disease Patent Scope and Landscape

U.S. Patent No. 12,144,792 protects methods of administering acetyl-leucine, including acetyl-DL-leucine and acetyl-L-leucine, to treat, delay, reverse, reduce, or prevent progression of specified neurodegenerative diseases. The broadest claims cover long-term administration for at least three months. Claim 1 adds a dosing schedule of at least twice daily and a total daily dose of approximately 500 mg to 15 g.

The patent is a method-of-use patent, not a composition, formulation, manufacturing, or product-by-process patent. Its commercial significance depends on whether acetyl-leucine is approved for any listed indication, whether a generic or competing product is marketed for those uses, and whether the claims survive validity challenges based on written description, enablement, anticipation, obviousness, and functional treatment language.

What does U.S. Patent 12,144,792 protect?

The patent has six principal independent claim categories:

Claim	Protected subject matter	Key limitations
1	Treatment of specified neurodegenerative diseases	At least three months; at least twice daily; 500 mg to 15 g total daily dose
7	Treatment of specified neurodegenerative diseases	Duration of at least 3 months, 6 months, 1 year, 2 years, or 5 years
8	Delaying disease or symptom progression	Comparison against typical disease progression; same disease exclusions
9	Reversing disease or symptom progression	Long-term administration; listed diseases
16	Reducing disease or symptom severity	At least three months; listed diseases
17	Neuroprotection	Applies to subjects having, suspected of having, or at risk of having a listed disease

The covered active ingredient is "acetyl-leucine or a pharmaceutically acceptable salt thereof." Dependent claims narrow the chemical scope to acetyl-DL-leucine, acetyl-L-leucine, and materials having an enantiomeric excess of either the L- or D-enantiomer.

The claims expressly exclude cerebellar ataxia and Niemann-Pick disease type C. Those exclusions are material because acetyl-leucine has historically been associated with development programs for neurological and lysosomal disorders, including cerebellar ataxia and Niemann-Pick type C.

Which diseases fall within the patent claims?

The listed diseases are:

Alzheimer's disease
Amyotrophic lateral sclerosis
Multiple system atrophy, parkinsonian type
Multiple system atrophy, cerebellar type
Frontotemporal dementia with parkinsonism
Progressive supranuclear palsy
Corticobasal degeneration
Lewy body dementia
Parkinson's disease
Ataxia telangiectasia, also identified in the claims as Louis-Bar disease

Claim 2 adds a disease-associated lysosomal dysfunction limitation. Claim 3 narrows that category to ALS, MSA-P, MSA-C, frontotemporal dementia with parkinsonism, progressive supranuclear palsy, Alzheimer's disease, and Louis-Bar disease.

Claims 4, 5, 6, and 10 through 11 create further subcategories:

Claim	Limitation
4	Progressive supranuclear palsy, Parkinson's disease, or Louis-Bar disease
5	Patient has a genetic or biochemical marker
6	Treatment delays expected disease onset or symptom onset
10	Administration begins while the patient is asymptomatic
11	Asymptomatic administration follows identification of a genetic or biochemical marker

The preventive claims are commercially important. They extend beyond treatment of diagnosed disease and potentially reach administration to genetically or biochemically identified at-risk subjects. Their practical enforceability will depend on the availability of validated biomarkers, the physician's knowledge of the patient's risk status, and whether the treatment objective is objectively measurable.

How broad is the acetyl-leucine dosing coverage?

Claim 1 recites a total daily dose of approximately 500 mg to 15 g administered at least twice daily. Claim 15 provides narrower dose ranges:

Claimed range	Commercial relevance
1 g to 15 g per day	Broad maintenance range
1 g to 10 g per day	Intermediate range
1.5 g to 7 g per day	Narrower therapeutic range
4 g to 6 g per day	High-dose range
4 g to 5 g per day	Narrowest expressly recited range

Claims 7 through 17 generally do not repeat the twice-daily or 500 mg to 15 g dosing limitation unless they depend on claim 1 or another dose-limited claim. This creates an important claim differentiation issue. A product or regimen may fall within the disease and duration language of claims 7, 8, 9, 16, or 17 while avoiding the specific dose and frequency limitations of claim 1.

The term "about" creates a customary range-of-equivalents issue. Courts generally interpret "about" in view of the specification, prosecution history, technical context, and the precision reasonably expected in the relevant field. The patent's specification and prosecution history would control whether a dose marginally outside a listed range is covered.

What formulations are protected by U.S. Patent 12,144,792?

The patent does not appear, based on the supplied claims, to require a particular formulation, dosage form, excipient, release profile, particle size, salt form, or route of administration.

The claims therefore potentially reach administration of:

Acetyl-DL-leucine
Acetyl-L-leucine
Acetyl-D-leucine or other enantiomerically enriched material
Pharmaceutically acceptable salts
Immediate-release or modified-release products
Tablets, capsules, powders, liquids, or other dosage forms

That breadth is useful against alternative dosage forms, but it also creates validity exposure. A challenger may argue that the claims cover an extensive range of formulations and stereochemical compositions without sufficient technical guidance or demonstrated efficacy across the full scope. The strength of that argument depends on the specification, examples, pharmacology, clinical data, and prosecution record.

No supplied claim separately protects a tablet formulation, a specific salt, an excipient combination, a controlled-release profile, or a manufacturing process. A competing manufacturer could therefore seek a separate formulation or process patent while still needing to assess infringement of the method claims.

Does the patent cover preventive and neuroprotective use?

Yes. Claims 10, 11, and 17 reach preventive or risk-based administration.

Claim 17 is particularly broad because it covers a subject who:

Has a neurodegenerative disease;
Is suspected of having the disease; or
Is at risk of having the disease.

Claims 10 and 11 focus on starting treatment while the subject is asymptomatic, including after identification of a genetic or biochemical marker.

These claims create potential coverage for prodromal or genetically defined populations. They are also more vulnerable to enforcement problems than claims directed to treatment of a diagnosed disease. In a typical clinical setting, the prescribing physician, specialty clinic, laboratory, or patient may possess different pieces of the information needed to establish infringement. The patent holder would need evidence that the claimed disease, risk state, marker, treatment purpose, duration, and drug administration all occurred.

How strong is the patent estate?

The supplied claims provide meaningful breadth in disease coverage and treatment objectives, but the apparent estate is concentrated in one therapeutic concept: long-term acetyl-leucine treatment for neurodegenerative disease.

Strengths

The disease list covers several large or clinically important markets, including Alzheimer's disease and Parkinson's disease.
The claims cover treatment, delay, reversal, symptom reduction, and neuroprotection.
The claims include both diagnosed and at-risk subjects.
Claims 13, 14, and 18 create stereochemical fallbacks.
The duration limitations may distinguish short-term symptomatic treatment from disease-modifying use.
The claims do not depend on a single biomarker, mechanism, or clinical endpoint.

Vulnerabilities

The claim set spans multiple heterogeneous diseases with different pathophysiologies.
Functional terms such as "delaying progression," "reversing progression," "neuroprotection," and "reducing severity" may require clear disclosure and measurable standards.
The claims broadly cover 500 mg to 15 g per day and multiple administration durations.
A challenger may contest enablement across all listed diseases, particularly where clinical evidence is concentrated in only one or two conditions.
The claims rely on treatment of diseases that may already have substantial prior art involving acetyl-leucine or related compounds.
The patent excludes cerebellar ataxia and Niemann-Pick type C, suggesting that the applicant deliberately separated the claimed indications from earlier or parallel acetyl-leucine programs.

A complete strength assessment requires the patent specification, file history, cited references, continuation chain, terminal disclaimers, and related family members. The claim text alone supports a high-level scope analysis but does not establish validity or enforceability.

What is the patent's expiration date?

The issue date of U.S. Patent 12,144,792 does not by itself establish the expiration date. U.S. utility patent term generally runs 20 years from the earliest effective nonprovisional filing date, subject to patent term adjustment, patent term extension, terminal disclaimers, and priority-chain complications (35 U.S.C. § 154).

The relevant expiration analysis must account for:

The earliest effective U.S. nonprovisional or PCT filing date;
Continuation, divisional, and continuation-in-part relationships;
Patent term adjustment;
Any terminal disclaimer;
Any patent term extension under 35 U.S.C. § 156;
Whether the patent claims priority to an earlier foreign filing.

The supplied claims do not contain those dates. An exact expiration date cannot be established from the claim text alone.

What is the FDA and Orange Book status?

Acetyl-leucine is not established by the supplied material as an FDA-approved active ingredient for the claimed neurodegenerative indications. The claims therefore should not be treated as evidence of FDA approval.

The Orange Book lists approved drug products and certain patent information submitted for approved products. A method-of-use patent generally becomes commercially relevant to the Orange Book only when it is associated with an approved drug product and submitted under FDA listing rules (FDA, 2024).

If acetyl-leucine is not approved for the claimed indications, the patent would not ordinarily create a conventional Orange Book Paragraph IV pathway for those indications. A future applicant seeking approval could face:

A patent certification issue if the patent is listed against an approved reference product;
A separate patent infringement action under Hatch-Waxman if the statutory requirements are met;
Method-of-use labeling restrictions;
Potential carve-out issues for patented indications.

The patent itself does not establish Orange Book listing, FDA approval, regulatory exclusivity, or New Chemical Entity exclusivity.

Are biosimilar or generic risks relevant?

Biosimilar risk is not the relevant framework because acetyl-leucine is a small molecule, not a biologic. The principal competitive risks are:

Generic acetyl-leucine products;
Compounded products;
Off-label use of acetyl-leucine;
Alternative salts or stereoisomeric products;
Competing neuroprotective therapies;
Products approved for overlapping neurological symptoms.

A generic applicant would need to evaluate whether its proposed labeling, dosage, indication, and promotional activity practice the patented methods. A product label that omits the patented indication may reduce, but does not automatically eliminate, infringement risk. Physician prescribing and manufacturer conduct remain relevant to induced infringement.

Which companies are challenging the patent?

No challenger, Paragraph IV notice, federal patent litigation, or settlement agreement is identified in the supplied claims. Patent claims do not establish litigation status.

The most likely commercial exposure would arise if a company seeks to market acetyl-leucine for one of the listed diseases, especially Parkinson's disease, Alzheimer's disease, ALS, or progressive supranuclear palsy. A challenge could assert:

Anticipation under 35 U.S.C. § 102;
Obviousness under 35 U.S.C. § 103;
Lack of written description under 35 U.S.C. § 112(a);
Lack of enablement under 35 U.S.C. § 112(a);
Indefiniteness under 35 U.S.C. § 112(b);
Noninfringement based on dose, duration, disease, formulation, or labeling.

No licensing deal or settlement agreement can be inferred from the claim language. Ownership, exclusive licensing, and commercialization rights must be determined from assignment records and corporate disclosures rather than the claims.

How does this patent compare with earlier acetyl-leucine patents?

The principal distinction is indication scope. The present claims exclude cerebellar ataxia and Niemann-Pick type C and focus on other neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, ALS, multiple system atrophy, progressive supranuclear palsy, and related disorders.

The patent also emphasizes:

Long-term administration;
Disease progression;
Preventive treatment;
Neuroprotection;
Genetic or biochemical markers;
Acetyl-DL-leucine and acetyl-L-leucine.

Earlier acetyl-leucine patents may cover different diseases, shorter treatment periods, symptomatic treatment, specific formulations, or distinct stereochemical compositions. Overlap must be assessed claim by claim. A product can avoid one patent while infringing another patent in the same family or therapeutic field.

What generic launch scenarios exist?

Scenario	Patent risk
Generic markets acetyl-leucine for a non-listed indication	Lower direct risk, subject to labeling and conduct
Generic markets for Parkinson's disease	High method-of-use exposure
Generic uses 4-5 g/day for at least three months	Directly aligned with narrow dose claims
Generic uses less than three months	May avoid duration limitations, subject to other claims
Generic uses a different salt	Potentially covered because pharmaceutically acceptable salts are included
Generic uses acetyl-DL-leucine	Expressly addressed by claim 13
Generic uses acetyl-L-leucine	Expressly addressed by claim 18
Generic uses a different formulation	No automatic avoidance because the claims are not formulation-specific
Generic omits patented indications from labeling	May reduce inducement risk but does not resolve all infringement issues

The highest-risk launch would involve a product labeled for long-term disease modification or neuroprotection in Parkinson's disease, Alzheimer's disease, ALS, MSA, progressive supranuclear palsy, or another listed disease.

Key Takeaways

U.S. Patent 12,144,792 is a broad method-of-use patent for long-term acetyl-leucine treatment of specified neurodegenerative diseases.
It covers treatment, progression delay, reversal, symptom reduction, and neuroprotection.
The claims expressly exclude cerebellar ataxia and Niemann-Pick type C.
Claim 1 covers at least twice-daily dosing totaling approximately 500 mg to 15 g per day.
Dependent claims specifically address acetyl-DL-leucine, acetyl-L-leucine, enantiomerically enriched material, genetic markers, biochemical markers, and asymptomatic treatment.
The patent does not, based on the supplied claims, separately protect a formulation, dosage form, manufacturing process, or specific salt.
Biosimilar analysis is not applicable; generic, off-label, compounding, and alternative-product risks are the relevant competitive issues.
The claims alone do not establish patent expiration, Orange Book listing, FDA approval, Paragraph IV activity, litigation, licensing, or settlement status.
The principal validity pressure points are enablement, written description, obviousness, functional treatment language, and the breadth of coverage across multiple diseases.

FAQs

Does U.S. Patent 12,144,792 cover acetyl-DL-leucine?

Yes. Claim 13 expressly identifies acetyl-DL-leucine as a claimed form of acetyl-leucine.

Does the patent cover acetyl-L-leucine?

Yes. Claim 18 expressly recites acetyl-L-leucine. Claim 14 also covers material having an enantiomeric excess of the L- or D-enantiomer.

Can a company avoid the patent by using a different acetyl-leucine salt?

Not necessarily. The claims include "a pharmaceutically acceptable salt thereof." A different pharmaceutically acceptable salt may remain within the claims.

Does a three-month treatment period matter?

Yes. Several independent claims require administration for at least approximately three months or longer. A shorter regimen may avoid some claims, although the complete claim set and prosecution history would control.

Is a biomarker required for every patented use?

No. Biomarker limitations appear in dependent claims 5 and 11. The principal treatment claims do not require a genetic or biochemical marker.

References

U.S. Patent No. 12,144,792. Claims 1-18. United States Patent and Trademark Office.
United States Code, 35 U.S.C. § 102. Conditions for patentability; novelty.
United States Code, 35 U.S.C. § 103. Conditions for patentability; non-obvious subject matter.
United States Code, 35 U.S.C. § 112. Specification requirements.
United States Code, 35 U.S.C. § 154. Contents and term of patent; provisional rights.
United States Code, 35 U.S.C. § 156. Extension of patent term.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Intrabio	AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132-001	Sep 24, 2024		RX	Yes	Yes	12,144,792	⤷ Start Trial				USE OF LEVACTEYLLEUCINE FOR TREATMENT OF ATAXIA TELANGIECTASIA (A-T)	⤷ 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	2017308865	⤷ Start Trial
Australia	2023202121	⤷ Start Trial
Australia	2025202077	⤷ Start Trial
Australia	2026203549	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,144,792

Which drugs does patent 12,144,792 protect, and when does it expire?

Summary for Patent: 12,144,792