Scope and claims analysis for US Patent 11,925,626 (relacorilant oral softgel formulation)
US Patent 11,925,626 is a formulation patent centered on a specific oral composition for relacorilant. Claim scope is dominated by (i) the identity of relacorilant as a defined chemical entity, (ii) tight weight-percent ranges for three excipient classes, and (iii) a particular softgel capsule construct using lauroyl polyoxyl glyceride as surfactant and propylene glycol monocaprylate as solubilizer, with optional incorporation of BHT at low levels. Dependent claims and dosage-unit claims further lock the system to softgel-containing embodiments with fixed mass quantities across multiple strength sizes.
What is US Patent 11,925,626 and what does it claim about relacorilant oral formulations?
Core answer. The patent claims an oral formulation of relacorilant with a specific excipient system and defined weight percentages:
- Relacorilant: about 18–22 wt%
- Surfactant: about 56–64 wt%, specifically lauroyl polyoxyl glyceride
- Solubilizer: about 18 wt%, specifically propylene glycol monocaprylate
- Optional antioxidant: BHT at about 0.02 wt% in the dependent “antioxidant” claims
- Dosage form limitation: “consisting essentially of a softgel capsule” in claim 13 and unit dose softgel embodiments in claims 14–21
How the relacorilant identity limits infringement risk
Claim 1 does not claim “relacorilant” generically; it recites a fully defined chemical name/structure: a (R)-relacorilant (as described in the claim) linked to a trifluoromethyl pyridine methanone motif. For design-around planning, the key is that the active ingredient scope is tethered to that specific defined relacorilant entity. Substituting a different stereoisomer or related analog would not satisfy the claim’s active-ingredient definition.
What the formulation ranges actually do to claim scope
Claim 1 uses “about” ranges for excipient percentages. That has two practical claim-life consequences:
- In-range products face literal claim risk if they use the same surfactant/solubilizer identities and their weight-percent composition lands inside the claimed “about” windows.
- Borderline products are largely a facts-and-expert-opinion fight because “about” is interpreted through prosecution history and technical meaning (not provided in the prompt), but the claim structure makes excipient identity and relative proportions the dominant infringement levers.
How do claims 1–12 define excipient chemistry and weight-percent boundaries?
Claim 1: base formulation (no antioxidant required)
Claim 1 is the foundational composition:
- oral formulation of the defined relacorilant molecule
- 18–22% relacorilant
- 56–64% lauroyl polyoxyl glyceride (surfactant)
- 18% solubilizer where the solubilizer is propylene glycol monocaprylate
- percentages are wt%
This claim sets the structural template for subsequent dependent claims.
Claim 2: adds antioxidant class
Claim 2 depends on claim 1 and adds:
- antioxidant selected from butylated hydroxytoluene (BHT)
Given the claim text you supplied, the antioxidant “selected from BHT” effectively narrows to BHT rather than a broader antioxidant family.
Claim 3: antioxidant level
Claim 3 narrows claim 2 further:
- about 0.02% antioxidant by weight (BHT level)
Claims 4–12: “consisting” fixed compositions
Claims 4–12 move from ranges to fixed formulations with exact weight percentages that sum to 100% and tie to explicit mass ratios.
Claim 4 (the template). “consisting of”:
- 20% relacorilant
- 59.98% surfactant (lauroyl polyoxyl glyceride)
- 20% solubilizer (propylene glycol monocaprylate)
- 0.02% antioxidant (BHT)
What “consisting of” changes. This is stricter than “comprising.” It materially narrows scope to formulations that do not include other components outside the listed ones (except for impurities or components not considered “additional” under claim construction). Products that add other excipients outside this set are less likely to be literally covered by claims 4–12.
Claims 5–12: quantitative unit-mass examples (same ratios, scaled strengths)
Claims 5–12 provide scaled mass embodiments linked to the same composition ratio:
- The surfactant and solubilizer mass scale with relacorilant mass.
- Antioxidant scales proportionally.
The quantities implied by each claim are consistent with the 20/59.98/20/0.02 wt% recipe.
Exact “consisting of” strength exemplars provided:
| Claim | Relacorilant (mg) | Lauroyl polyoxyl glyceride surfactant (mg) | Propylene glycol monocaprylate solubilizer (mg) | BHT antioxidant (mg) |
|---|---:|---:|---:|---:|
| 5 | 25 | 74.975 | 25 | 0.025 |
| 6 | 50 | 149.95 | 50 | 0.05 |
| 7 | 100 | 299.9 | 100 | 0.1 |
| 8 | 150 | 349.85 | 150 | 0.15 |
| 9 | 200 | 599.8 | 200 | 0.2 |
| 10 | 300 | 899.7 | 300 | 0.3 |
| 11 | 400 | 1199.6 | 400 | 0.4 |
| 12 | 500 | 1499.5 | 500 | 0.5 |
Practical read across. These claims appear designed to cover multiple commercial “strength” softgel fill masses while keeping the same excipient identity and fixed ratios.
What does claim 13 do with “softgel capsule” and “consisting essentially of”?
Claim 13: formulation inside a softgel construct
Claim 13 claims:
- “consisting essentially of a softgel capsule containing” a relacorilant formulation comprising:
- 20% relacorilant
- 59.98% surfactant (lauroyl polyoxyl glyceride)
- 20% solubilizer (propylene glycol monocaprylate)
- 0.02% BHT antioxidant
- percentages are wt%
Key legal effect. “consisting essentially of” is less rigid than “consisting of.” It allows some additional components if they do not materially affect the basic and novel characteristics of the claimed invention. In practice, this gives more room for softgel shell materials, process-related materials, and small auxiliary components, compared with claims 4–12.
Claim 13’s scope is therefore broader than claims 4–12 in terms of allowable additional components around/within the softgel capsule shell and handling components, but it still requires the internal fill to match the recited excipient percentages and the softgel capsule context.
What do claims 14–21 protect: specific unit dose strengths in softgel capsules?
Claim 14–21: unit dose softgel embodiments
Claims 14–21 depend on claim 13 and specify softgel capsule fill masses corresponding to the scaled formulations.
| Claim |
Relacorilant (mg) |
Lauroyl polyoxyl glyceride (mg) |
Propylene glycol monocaprylate (mg) |
BHT (mg) |
| 14 |
25 |
74.975 |
25 |
0.025 |
| 15 |
50 |
149.95 |
50 |
0.05 |
| 16 |
100 |
299.9 |
100 |
0.1 |
| 17 |
150 |
349.85 |
150 |
0.15 |
| 18 |
200 |
599.8 |
200 |
0.2 |
| 19 |
300 |
899.7 |
300 |
0.3 |
| 20 |
400 |
1199.6 |
400 |
0.4 |
| 21 |
500 |
1499.5 |
500 |
0.5 |
Infringement implication. A manufacturer selling different strength capsules that keep the internal fill composition in the same fixed ratios would be at risk if their actual formulation falls within the literal recitations of each unit dose claim.
How strong is this patent estate likely to be on composition vs. dosage form vs. method-of-use?
What this patent covers (composition and product configuration)
This patent is a formulation/product patent:
- composition composition: relacorilant + lauroyl polyoxyl glyceride + propylene glycol monocaprylate + BHT at specified wt%
- dosage form: softgel capsule
- optional antioxidant addition: controlled in dependent claims
Notably absent in the claim text you provided:
- no explicit dosing regimen (method-of-use)
- no permeability/PK enhancement mechanism
- no manufacturing steps (process claims)
- no polymorph/crystal form specification of relacorilant
- no specific capsule fill handling (e.g., microencapsulation) beyond the softgel capsule framing
How the “consisting of” and “consisting essentially of” split affects enforceability
- Claims 4–12 are tightly confined by “consisting of,” raising the bar for literal infringement for any product with additional excipients in the fill.
- Claims 13 and 14–21 use “consisting essentially of,” improving enforceability against competitors that keep the core fill and softgel format but may add minor/immaterial components.
What generic entry risks exist for relacorilant if competitors replicate the excipient system?
High-risk design targets for generic/formulation challengers
The principal infringement tripwires are:
- Use of lauroyl polyoxyl glyceride as the surfactant in the claimed proportion window (claim 1) or at 59.98 wt% (claims 4–13).
- Use of propylene glycol monocaprylate as solubilizer in the claimed proportion window (claim 1) or at 20 wt% (claims 4–13).
- Inclusion of BHT at around 0.02 wt% (claims 2–4, and all “consisting of” exemplars).
- Softgel capsule format (claim 13+) and fixed fill strength masses (claims 14–21).
Lower-risk paths from a claim-scope perspective
- Replace lauroyl polyoxyl glyceride with a different surfactant: would evade claims that require this specific surfactant identity.
- Replace propylene glycol monocaprylate with a different solubilizer: same.
- Remove BHT or replace with a different antioxidant: would evade dependent claims requiring BHT at 0.02%.
- Change the fill ratios outside the tight fixed 20/59.98/20/0.02 recipe: reduces literal infringement likelihood.
- Use a non-softgel oral dosage form: avoids claim 13+ if “softgel capsule” is interpreted strictly as a limitation.
How does this patent compare with typical relacorilant patent patterns (formulation vs. API vs. crystalline forms)?
From the provided claims alone, US 11,925,626 is structurally an “excipient recipe” patent. In most relacorilant development programs, a full landscape usually contains:
- API synthesis or stereochemistry patents (scope depends on the active entity)
- crystalline/amorphous/polymorph patents (solid-state exclusivities)
- formulation patents (excipient systems, dosage form templates)
- process patents (manufacturing steps, mixing, encapsulation)
- method-of-use patents (clinical dosing claims)
US 11,925,626 sits primarily in the formulation/dosage form segment, with no method-of-use content shown.
What patent-claim overlap and blocking behavior should be expected in litigation?
Likelihood of “stacked” obstacles
Even without additional patents listed in the prompt, US 11,925,626’s structure suggests that a challenged generic product would face:
- at least one “composition” barrier (claims 1–12)
- at least one “softgel construct” barrier (claims 13–21)
A defendant could argue that they avoid one prong (e.g., different surfactant), but if they still land inside claim 1’s broad “about” ranges with the same surfactants, they may fall back into claim 1 even if they avoid claim 4’s “consisting of.”
Settlement leverage dynamics
In settlement discussions, the strongest leverage typically comes from:
- clear structural match on excipient identities
- clear softgel use
- clear proportional fill composition
This patent is highly specific on those points.
Key patent claim elements summary (for infringement mapping)
| Claim group |
Required active |
Surfactant |
Solubilizer |
Antioxidant |
Composition standard |
Dosage form |
| Claim 1 |
defined relacorilant |
lauroyl polyoxyl glyceride (56–64 wt%) |
propylene glycol monocaprylate (~18 wt%) |
none required |
range-based “about” |
oral formulation (no softgel limitation in claim 1) |
| Claims 2–3 |
defined relacorilant |
lauroyl polyoxyl glyceride |
propylene glycol monocaprylate |
BHT ~0.02 wt% |
dependent |
oral formulation |
| Claims 4–12 |
defined relacorilant |
lauroyl polyoxyl glyceride 59.98 wt% |
propylene glycol monocaprylate 20 wt% |
BHT 0.02 wt% |
“consisting of” fixed recipe |
not limited to softgel in claim 4–12 text (softgel appears starting claim 13) |
| Claim 13 |
defined relacorilant |
lauroyl polyoxyl glyceride 59.98 wt% |
propylene glycol monocaprylate 20 wt% |
BHT 0.02 wt% |
“consisting essentially of” |
softgel capsule |
| Claims 14–21 |
defined relacorilant |
scaled to fill mass |
scaled to fill mass |
scaled BHT |
softgel capsule unit dose |
softgel |
Key Takeaways
- US 11,925,626 is a high-specificity relacorilant oral softgel formulation patent anchored to a single excipient system: lauroyl polyoxyl glyceride + propylene glycol monocaprylate, with BHT at about 0.02 wt% in dependent claims.
- The claim set has two enforcement tiers: “consisting of” fixed recipe claims (4–12) and “consisting essentially of” softgel capsule claims (13–21), with the softgel language starting at claim 13.
- The most material design-around levers are excipient identity (swap surfactant or solubilizer), BHT inclusion, softgel format, and fill-ratio deviations from the fixed 20/59.98/20/0.02 recipe.
FAQs
-
Does US 11,925,626 cover relacorilant oral liquids or tablets, or is it limited to softgels?
The softgel limitation is explicit starting at claim 13; claims 1–12 are not textually limited to softgels in what you provided.
-
If a competitor uses the same surfactant and solubilizer but changes the antioxidant, is it still covered?
Dependent claims 2–3 require BHT, while claim 1 does not. Coverage depends on whether the formulation is pursued under claim 1 or remains in the BHT-dependent claim chain.
-
What is the highest-risk strength range for copying the formulation?
Claims 14–21 list multiple unit dose exemplars (25 mg through 500 mg relacorilant fill masses) following the fixed wt% recipe.
-
Can a generic avoid “consisting of” claims by adding additional excipients to the fill?
“Consisting of” narrows literal scope; adding additional fill excipients may avoid claims 4–12, but “consisting essentially of” in claim 13 can still capture formulations with additional components that do not materially affect the core characteristics.
-
Does the patent protect relacorilant’s chemical synthesis or just the formulation composition?
Based on the supplied claims, the protection is directed to the formulation composition and softgel capsule embodiment, not synthesis or method-of-use.
References
- US Patent 11,925,626, claims provided in prompt (claim set 1–21).
