United States Patent 11,464,764 (Relacorilant) Claims Scope, Claim Coverage, and US Patent Landscape
US Patent 11,464,764 claims a narrow oral formulation and unit-dose softgel composition for relacorilant, defined by three excipients at fixed weight percentages: about 20% relacorilant, about 60% lauroyl poloxyl-32 glycerides, about 20% propylene glycol monocaprylate, plus an antioxidant (BHT) at about 0.02% (with multiple explicit unit-dose mass examples). The patent’s enforceable scope is driven by (i) the specific excipient identity, (ii) the weight-ratio ranges/“consisting” limitations for dependent forms, and (iii) the antioxidant inclusion and its specific amount.
What is the scope of US Patent 11,464,764’s claims for relacorilant oral softgels?
Short answer: Coverage is restricted to relacorilant formulations for oral administration where the drug and excipient system matches the claimed proportional recipe, with narrower coverage for “consisting” embodiments that fix component amounts and include BHT at specified levels.
What does independent claim 1 cover?
Claim 1 is directed to:
- An oral formulation comprising:
- About 20% relacorilant
- About 60% lauroyl poloxyl-32 glycerides
- About 20% propylene glycol monocaprylate
- By structure: the relacorilant chemical entity is explicitly recited (the specified relacorilant structure)
- Percentages are weight percent.
- Claim 1 does not expressly recite BHT as a required component; it recites the base three-component composition.
Practical scope implications
- A formulation can potentially fall within claim 1 even if antioxidant is absent, because claim 2 is the antioxidant-dependent path.
- The scope is still constrained by excipient identity and the weight proportions being “about” 20/60/20.
What do dependent claims 2 and 3 add?
- Claim 2: Adds an antioxidant to the claim-1 formulation.
- Claim 3: Specifies antioxidant content at about 0.02%.
Practical scope implications
- Claim 2 and 3 require an antioxidant but do not confine identity yet (claim 3 says antioxidant at about 0.02% but not that it must be BHT).
- That said, later claims lock to BHT for “consisting” embodiments.
What is the narrowest, most enforceable coverage: the “consisting of” BHT embodiments?
Claim 4 (key bottleneck claim) recites:
- “consisting of”
- 20% relacorilant
- 59.98% lauroyl poloxyl-32 glycerides
- 20% propylene glycol monocaprylate
- 0.02% Butylated hydroxytoluene (BHT)
This matters because “consisting of” is a tighter drafting choice than “comprising.” It limits the formulation to the listed ingredients and prevents insertion of other components unless they are not considered additional ingredients.
Claims 5–12 scale claim 4 to explicit mass unit examples (still “consisting of”):
- 0.025 mg BHT at 25 mg relacorilant scale
- 0.05 mg BHT at 50 mg relacorilant scale
- 0.1 mg BHT at 100 mg relacorilant scale
- 0.2 mg BHT at 200 mg relacorilant scale
- 0.3 mg BHT at 300 mg relacorilant scale
- 0.4 mg BHT at 400 mg relacorilant scale
- 0.5 mg BHT at 500 mg relacorilant scale
- 0.75 mg BHT at 750 mg relacorilant scale
Each example preserves the proportional system and fixes BHT inclusion.
What do claims 13–23 cover (unit dose softgel)?
Claim 13:
- A “unit dose” for oral administration in a softgel capsule
- Contains a relacorilant formulation consisting essentially of:
- 20% relacorilant
- 59.98% lauroyl poloxyl-32 glycerides
- 20% propylene glycol monocaprylate
- 0.02% BHT
- Percentages are weight percent.
“Consisting essentially of” is narrower than “comprising” but allows some departures not materially affecting basic and novel characteristics.
Claims 14–21:
- Softgel unit doses with explicit mass amounts for 25/50/100/200/300/400/500/750 mg relacorilant formats
- Include corresponding masses of:
- lauroyl poloxyl-32 glycerides
- propylene glycol monocaprylate
- BHT (0.001× relacorilant mass at these examples: e.g., 25 mg drug includes 0.025 mg BHT)
Claims 22–23:
- Additional explicit mass example:
- 150 mg relacorilant format
- 349.85 mg lauroyl poloxyl-32 glycerides
- 150 mg propylene glycol monocaprylate
- 0.15 mg BHT
Where does the claim hierarchy tighten or loosen coverage?
- Broadest: claim 1 (about 20/60/20; no antioxidant required).
- Intermediate: claims 2–3 (antioxidant present; ~0.02% antioxidant).
- Narrowest formulation coverage: claim 4 and claims 5–12 (“consisting of” with BHT identity and fixed percentages).
- Most operationally relevant: claims 13–23 (softgel unit dose with the “consisting essentially of” structure plus fixed mass exemplars).
How many US claims target BHT antioxidant and fixed excipient ratios?
BHT and fixed recipe coverage (directly from provided claim set):
- BHT identity explicitly required in:
- Claim 4
- Claim 5 through 12
- Claim 13 (via composition)
- Claim 14 through 21
- Claim 22 through 23
- Antioxidant content and identity constraints:
- Claim 3 sets ~0.02% antioxidant for antioxidant embodiments (without identity)
- Claim 4 fixes BHT at 0.02% and “consisting of” language
- Unit-dose claims fix BHT amount proportional to relacorilant dose in the given examples.
Count note: The total set provided includes claims 1–23, where claims 2–3 cover antioxidant generically (with amount in 3), and claims 4–23 heavily anchor to BHT and fixed excipient systems.
What formulation elements are legally “essential” under claim language?
Excipient identity constraints
The claims require:
- lauroyl poloxyl-32 glycerides
- propylene glycol monocaprylate
Design-around requires changing at least one excipient identity or the ratio such that it no longer meets the “about” 20/60/20 (claim 1) or the fixed “consisting of” recipe (claim 4 and dependents).
Ratio constraints and the role of “about” vs fixed values
- Claim 1 uses “about” for the 20/60/20 ratios.
- Claim 4 uses fixed values (20%, 59.98%, 20%, 0.02%) under “consisting of.”
- Dependent BHT examples use fixed mass equivalents tied to the same ratio logic.
Antioxidant identity and inclusion
- Claims 2–3 permit antioxidant generally at ~0.02%.
- Claims 4 and all “consisting of” formulations require BHT specifically.
- Claims 13–23 also include BHT, tied to the capsule unit dose formulation definition.
How do claim types affect infringement risk for competitors?
If a generic or branded competitor uses the same excipient system but changes antioxidant
- High risk for coverage under claim 4/5–12 if BHT is omitted or replaced with a different antioxidant, because “consisting of” requires the listed ingredients.
- Moderate risk for claim 2/3 if another antioxidant is used at ~0.02% and excipient ratios remain within claim 1 ranges.
If a competitor changes excipient identity but keeps proportions
- Changing lauroyl poloxyl-32 glycerides to another surfactant/lipid vehicle is likely to avoid claim 1’s exact excipient requirement.
- “About” ratio alone is not enough; excipient identity is an explicit claim element.
If a competitor changes softgel format or dosage form
- Claims 13–23 are limited to a softgel capsule unit dose with the formulation definition.
- If a competitor uses the same formulation in a different dosage form (e.g., tablet, capsule powder), claim 13–23 may not apply, but claims 1–12 (formulation for oral administration) could still be asserted depending on how the formulation is practiced.
If a competitor scales dose differently
- Claims 5–12 and 14–21 list specific mass examples, but these are dependent claims that track claim 4 proportions.
- A scaled dose that preserves the same fixed percentages could still fall within the “consisting of” logic if the formulation is identical by weight percent; however, the provided text shows exact unit-dose mass dependents rather than “any dose” language.
Where does the patent sit in the US relacorilant exclusivity and landscape?
No bibliographic data, specification excerpts, prosecution history, filing dates, assignee, or related US family members were provided. Without those, the US expiration dates, statutory term, pediatric adjustment, PTA, and cross-family relationship cannot be computed from the claim text alone.
Given only the claim language, the defensible landscape analysis is limited to the scope mechanics: fixed excipient ratios, antioxidant identity (BHT) in the narrow set, and softgel unit dose framing.
What is the likely claim construction focus in litigation for US 11,464,764?
Key construction issues that will drive infringement and validity arguments:
- “about 20%” and related “about” language in claim 1
- How close to 20/60/20 must a formulation be to meet “about,” in percent by weight.
- The meaning and boundaries of “consisting essentially of” (claim 13)
- What additional capsule components (shell materials, other excipients) are considered materially affecting the claimed formulation’s basic and novel characteristics.
- “consisting of” strictness (claim 4 and 5–12)
- Whether impurities, capsule excipient carryover, or stability additives outside BHT are additional “ingredients” excluded by “consisting of.”
- “lauroyl poloxyl-32 glycerides” specification
- Whether the excipient is interpreted by chemical identity vs trade designation, and how variants or grades are treated.
- “antioxidant” in claims 2–3
- Whether the antioxidant must be BHT (not stated there) or whether any antioxidant meeting the functional role qualifies at ~0.02%.
What design-arounds are most likely to avoid infringement based on claim wording?
Avoid claim 4 / 5–12 (strictest)
- Use a formulation that does not “consist of” the exact ingredient set including BHT at 0.02%.
- Replace BHT with a different antioxidant at the same or different level, or include additional ingredients beyond the “consisting of” list.
- Change at least one of:
- relacorilant weight percent,
- lauroyl poloxyl-32 glycerides identity,
- propylene glycol monocaprylate identity,
- or the exact ratio values.
Avoid claim 1 (broadest)
- Replace one excipient with a different excipient identity.
- Move out of the “about 20% / about 60% / about 20%” weight percent band.
Avoid claims 13–23 (softgel unit dose)
- Deliver the same formulation in a non-softgel dosage form.
- Use a capsule format where the formulation as practiced does not meet “consisting essentially of” constraints (for example, inclusion of additional excipients considered material).
Key takeaways
- US 11,464,764 is an oral formulation and unit-dose softgel patent for relacorilant defined by a specific vehicle system: lauroyl poloxyl-32 glycerides and propylene glycol monocaprylate at about 20/60/20 weight percent in claim 1.
- The patent’s narrowest enforceable core is the “consisting of” BHT embodiment (claim 4): 20% relacorilant / 59.98% lauroyl poloxyl-32 glycerides / 20% propylene glycol monocaprylate / 0.02% BHT.
- Unit-dose claims (13–23) lock the same composition into softgel capsule formats with multiple explicit dose-scale examples and fixed BHT mass amounts.
- In infringement analysis, the highest-risk targets are formulations using the exact excipient identities with BHT at ~0.02% in softgel units; the most effective design-arounds change excipient identity and/or avoid the “consisting of” BHT recipe.
FAQs
1) Does US 11,464,764 cover relacorilant formulations without any antioxidant?
Claim 1 does not require an antioxidant; antioxidant-dependent coverage begins at claim 2.
2) Is BHT required for coverage under the broadest claim?
No. BHT is explicitly required starting in the “consisting of” claim set (claim 4 and dependents). Claim 1 and claims 2–3 can cover antioxidant inclusion without specifying BHT identity.
3) Can a competitor avoid the patent by keeping the same excipient ratios but using a different surfactant?
Likely. Excipient identity is an explicit element: lauroyl poloxyl-32 glycerides and propylene glycol monocaprylate must match the claim.
4) Does the softgel limitation mean tablets are free of risk?
Claims 13–23 are softgel-specific, but claims 1–12 cover formulations for oral administration, so risk can remain if the same formulation is used in another oral dosage form.
5) Do the listed mg examples define the only infringing unit doses?
The dependents list specific mass embodiments tied to fixed compositions. The safest exposure is using compositions that match the same weight percent and BHT ratio logic underlying those examples.
References
- United States Patent 11,464,764 (provided claim set: claims 1–23).
