Details for Patent: 12,514,849

Which drugs does patent 12,514,849 protect, and when does it expire?

Patent 12,514,849 protects LIFYORLI (COPACKAGED) and is included in one NDA.

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

Summary for Patent: 12,514,849

Title:	Pharmaceutical formulations containing relacorilant, a heteroaryl-ketone fused azadecalin compound
Abstract:	Disclosed herein are novel formulations containing relacorilant ((R)-(1-(4-fluorophenyl)-6-((1-methyl-1H-pyrazol-4-yl)sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl)(4-(trifluoromethyl)pyridin-2-yl)methanone) that are suitable for administration, including oral administration, to patients suffering from disorders amenable to treatment by glucocorticoid receptor modulators (GRMs). Single unit dosage forms comprise softgel capsules containing these formulations. Such softgel capsules may contain, e.g., relacorilant formulations containing 25 milligrams (mg), 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, or other amounts of relacorilant. These novel formulations and single unit dosage forms may be used to treat diseases and disorders including Cushing's syndrome, Cushing's Disease, and other disorders.
Inventor(s):	Ian Scott, Travis Lemons, Yip-Fong Chia
Assignee:	Corcept Therapeutics Inc
Application Number:	US18/427,477
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Patent 12,514,849 scope, claim chart, and US patent landscape for relacorilant oral formulations with polyoxyl glycerides and propylene glycol monocaprylate

United States Patent 12,514,849 is a formulation patent that claims an oral delivery composition containing relacorilant plus a defined excipient system built around polyoxyl glyceride compounds (specifically lauroyl poloxyl-32 glycerides in dependent claims), propylene glycol monocaprylate, and an optional antioxidant (BHT or BHA), with explicit weight percent ranges and multiple exemplified dosage mass combinations. The practical claim scope is narrow because it is constrained to both (i) the specific active (relacorilant with a defined structure) and (ii) a specific excipient architecture (polyoxyl glyceride + propylene glycol monocaprylate) and (iii) defined BHA/BHT presence and level in later dependent claims.

What does US 12,514,849 claim for oral relacorilant formulations?

Featured snippet answer: US 12,514,849 claims an oral formulation of relacorilant comprising ~20 wt% relacorilant, ~60 wt% polyoxyl glyceride compounds, and ~20 wt% propylene glycol compounds, with dependent claims narrowing to an antioxidant (BHA/BHT) and then to lauroyl poloxyl-32 glycerides and an explicit BHT level, including “consisting of” compositions with set mass examples.

Claim 1: core excipient system and weight percent structure

Independent claim 1 is a formulation claim for oral administration of the specific relacorilant structure. It recites:

• Relacorilant (specific chemical structure is defined in the claim)
• Formulation comprising (weight percent, not molar):
  • about 20% relacorilant
  • about 60% polyoxyl glyceride compounds
  • about 20% propylene glycol compounds

Scope impact

• “About” introduces flexibility but still anchors the composition around a tight stoichiometry of excipients.
• The claim is limited to polyoxyl glyceride compounds as a class and propylene glycol compounds as a class at the “about 20%” level. The claim does not yet restrict to any particular polyoxyl glyceride or any particular propylene glycol derivative in claim 1.

Claim 2: antioxidant addition (BHA or BHT)

Dependent claim 2 adds:

• antioxidant selected from BHA and BHT

Scope impact

• This introduces an additional excipient requirement. If an accused product uses no antioxidant, it may fall outside claim 2 but could still fall within claim 1 if it satisfies claim 1’s excipient ranges without the antioxidant and if the antioxidant is not treated as intrinsic/implicit.
• If the accused formulation uses a different antioxidant (not BHA/BHT), claim 2 does not read on it, though claim 1 remains the fallback.

Claim 3: antioxidant level fixed at 0.02%

Dependent claim 3 limits claim 2 to:

• antioxidant at about 0.02% (by weight)

Scope impact

• This is a narrow quantitative limiter.
• If a product uses BHT/BHA at materially different levels, it is less likely to meet claim 3, though it could still meet claim 2 (if it meets claim 2’s selection requirement) and then return to claim 1 for the broader excipient system.

Claim 4: polyoxyl glyceride limited to lauroyl polyoxy glyceride compounds

Dependent claim 4 specifies:

• polyoxyl glyceride compounds are lauroyl polyoxy glyceride compounds

Scope impact

• Constrains the excipient class further.
• “Lauroyl polyoxy glyceride” is narrower than generic polyoxyl glycerides.

Claim 5: “consisting of” composition with defined excipients

Dependent claim 5 is materially stronger for infringement arguments because it uses closed language:

consisting of 20% relacorilant, 59.98% Lauroyl poloxyl-32 glycerides, 20% Propylene glycol monocaprylate, and 0.02% BHT.

Scope impact

• “Consisting of” generally excludes other components (except those that do not materially affect the “consisting of” boundary). Any formulation with additional excipients beyond the listed items may be argued to fall outside claim 5.
• This claim also fixes the exact excipient identities:
  • Lauroyl poloxyl-32 glycerides
  • Propylene glycol monocaprylate
  • BHT at 0.02%

Claims 6–13: scaled “consisting of” batch-size examples

Claims 6–13 recite consisting of compositions with fixed mass relationships. The same relative ratios appear throughout:

• Relacorilant mass
• Lauroyl poloxyl-32 glycerides mass ~ 2.999× relacorilant
• Propylene glycol monocaprylate mass equal to relacorilant
• BHT mass ~ 0.0001× relacorilant (since 0.02 wt% in claim 5 corresponds to 0.025 mg BHT at 25 mg active, 0.05 mg at 50 mg, etc.)

Claim-by-claim:

Claim	“Consisting of” relacorilant	Lauroyl poloxyl-32 glycerides	Propylene glycol monocaprylate	BHT
6	25 mg	74.975 mg	25 mg	0.025 mg
7	50 mg	149.95 mg	50 mg	0.05 mg
8	100 mg	299.9 mg	100 mg	0.1 mg
9	200 mg	599.8 mg	200 mg	0.2 mg
10	300 mg	899.7 mg	300 mg	0.3 mg
11	400 mg	1199.6 mg	400 mg	0.4 mg
12	500 mg	1499.5 mg	500 mg	0.5 mg
13	750 mg	2249.25 mg	750 mg	0.75 mg

Scope impact

• These are “closed” compositions with exact ratios and explicit BHT amounts at scaled pack sizes.
• If an accused product uses the same active/excipient system but with slightly different ratios or antioxidant levels, the “consisting of” limitations can matter.

How is the relacorilant structure used in infringement scope?

Claim 1 ties relacorilant to a defined chemical entity:

• (R)-(1-(4-fluorophenyl)-6-((1-methyl-1H-pyrazol-4-yl) sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl) (4-(trifluoromethyl) pyridin-2-yl) methanone

Scope impact

• A generic defendant that substitutes a different stereoisomer, salt form, prodrug, or analog could argue non-infringement if the formulation does not contain the claimed relacorilant entity as defined.
• Practically, if the marketed drug ingredient is the same relacorilant entity (not a different form), this structural limiter will not avoid claim 1.

What is the independent claim coverage if a product uses different polyoxyl glycerides or propylene glycol derivatives?

Because claim 1 is class-based and claim 5 is species-based, claim coverage depends on excipient identity:

If the product uses polyoxyl glycerides other than lauroyl poloxyl-32 glycerides

• It may still potentially fall within claim 1 if it uses polyoxyl glyceride compounds at ~60 wt% and propylene glycol compounds at ~20 wt%.
• It may avoid claim 4/claim 5 if it is not “lauroyl polyoxy glyceride” or not “Lauroyl poloxyl-32 glycerides.”

If the product uses a different propylene glycol compound than propylene glycol monocaprylate

• Claim 1 only requires “propylene glycol compounds” at ~20 wt%.
• Claim 5 requires propylene glycol monocaprylate, so substitution could avoid claim 5 while leaving claim 1 as the relevant risk.

If the product uses no BHT/BHA

• Claim 1 remains possible coverage.
• Claims 2–3 and 5–13 would not read without the antioxidant or correct level, depending on claim construction and whether other antioxidants could be argued to satisfy “selected from” language (they should not).

What formulations are protected by the “consisting of” language?

The most enforceable elements are in claim 5 and claims 6–13 because they are closed:

• Relacorilant
• Lauroyl poloxyl-32 glycerides
• Propylene glycol monocaprylate
• BHT at a specific wt% (0.02%) or corresponding mg amounts in the mass-scaled examples

Practical infringement friction

• Products that add other formulation components (typical in oral dosage manufacturing) can be designed to argue outside “consisting of.”
• If an accused product contains additional excipients, the key issue becomes whether those additions are permitted as incidental, unavoidable impurities, or fall outside the “consisting of” boundary. The claims as written are best read as excluding other deliberate ingredients.

How would a generic entry or reformulation attempt be analyzed against this estate?

A typical risk screen:

1. Active ingredient matches relacorilant entity
   • If yes, proceed to excipient alignment.
2. Excipients match the claim 1 weight architecture
   • ~20/60/20 relacorilant/polyoxyl glyceride/propylene glycol.
3. Antioxidant inclusion
   • If BHT/BHA absent, claims 2/3/5–13 are unlikely.
4. Excipients species match claim 5
   • Lauroyl poloxyl-32 glycerides + propylene glycol monocaprylate + BHT at 0.02%.
5. Closed-formulation trap
   • “Consisting of” raises barriers to adding other ingredients or changing ratios slightly.

This creates two viable design-around pathways:

• stay within claim 1’s broad architecture but avoid claim 5/6–13 by changing the excipient species or antioxidant; or
• change the composition so it does not meet claim 1’s ~20/60/20 scheme and avoids claim 1 entirely.

What other US patents likely exist around this formulation, and how would they overlap?

On the record provided, only the text of US 12,514,849 claims is available. No prosecution history, patent family members, priority dates, specification details, or related US application numbers are provided. Without those, a complete landscape cannot be produced, and the analysis must stop at claim scope mechanics rather than listing specific adjacent patents.

Claim-structure-based landscape inference (limited to scope overlap, not specific patent IDs):

• This estate is positioned like a formulation composition-of-matter around a specific excipient system.
• Overlap typically occurs with:
  • other relacorilant formulation patents with different excipient ratios,
  • patents for alternative antioxidants (different than BHA/BHT),
  • patents for different polyoxyl glyceride types,
  • patents for dosage forms (capsules/tablets vs solutions/suspensions) that may use the same excipient system but differ in additional ingredients,
  • patents directed to manufacturing processes, particle formation, or stability.

Because claim 5 is closed and very specific, adjacent patents that use the same active but alter excipients or the antioxidant are the primary “fence posts” that usually expand around such a formulation.

Key claim-scope takeaways for enforcement and design-around

• Claim 1 is the “broadest” hook: it requires the specific relacorilant plus the ~20/60/20 weight-percent architecture using polyoxyl glycerides and propylene glycol compounds.
• Claims 2–3 add antioxidant requirements and then fix the antioxidant level to ~0.02%.
• Claims 4–5 narrow polyoxyl glycerides to lauroyl polyoxy glycerides, then pin the composition to Lauroyl poloxyl-32 glycerides plus propylene glycol monocaprylate plus BHT in a consisting-of formulation.
• Claims 6–13 are scaled consisting-of examples that preserve the same ratios, making “near-miss” reformulations a more plausible design-around target than a wholesale different excipient system, assuming the accused product avoids additional components or shifts ratios.

Key Takeaways

• US 12,514,849 protects a specific oral relacorilant excipient architecture: ~20 wt% relacorilant, ~60 wt% polyoxyl glycerides, ~20 wt% propylene glycol compounds (claim 1).
• The strongest infringement posture sits in claim 5 (and claims 6–13) due to “consisting of” and fixed excipient identities: Lauroyl poloxyl-32 glycerides + propylene glycol monocaprylate + BHT (0.02 wt%).
• Design-around risk rises or falls with excipient species (lauroyl poloxyl-32), antioxidant presence/level (BHT vs none; 0.02 wt%), and ratio matching (and whether additional excipients are used that conflict with “consisting of”).

FAQs

1. Does US 12,514,849 require BHT specifically or will BHA satisfy the patent?
   BHA can satisfy claim 2, but claim 5 and claims 6–13 require BHT at the specified 0.02 wt% level (or corresponding mass amounts).

2. If a formulation uses lauroyl polyoxy glycerides but not Lauroyl poloxyl-32 glycerides, what claims are implicated?
   It may still fall within claim 1 if the weight-percent architecture is met, but it is less likely to meet claims 4–5 that narrow to lauroyl poloxyl-32 glycerides.

3. Can a product that includes additional excipients still infringe claim 5?
   Claim 5 uses “consisting of”, so added intentional excipients create a non-infringement risk depending on claim construction and whether additions are excluded by the closed language.

4. Are the mass-based claims 6–13 tied to specific dosage units?
   They are written as consisting-of compositions with fixed mass ratios, which function as dosage-scaled embodiments, but the claim language centers on the composition amounts, not a named dosage form.

5. What is the fastest “ratio change” design-around against this claim set?
   Moving away from the anchored composition ratios and antioxidant level can reduce exposure to claim 5 and the scaled embodiments, while still leaving claim 1 as the broader risk if the formulation remains close to the ~20/60/20 architecture.

Drugs Protected by US Patent 12,514,849

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes			Y

International Family Members for US Patent 12,514,849

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019404026
Brazil	112021010461
Canada	3121193