Details for Patent: 10,456,392

Which drugs does patent 10,456,392 protect, and when does it expire?

Patent 10,456,392 protects LIFYORLI (COPACKAGED) and is included in one NDA.

This patent has sixty-nine patent family members in twenty-five countries.

Summary for Patent: 10,456,392

Title:	Heteroaryl-ketone fused azadecalin glucocorticoid receptor modulators
Abstract:	The present invention provides heteroaryl ketone fused azadecalin compounds and methods of using the compounds as glucocorticoid receptor modulators.
Inventor(s):	Hazel Hunt, Tony Johnson, Nicholas Ray, Iain Walters
Assignee:	Corcept Therapeutics Inc
Application Number:	US15/889,494
Patent Claim Types: see list of patent claims	Use;

Executive summary US Patent 10,456,392 claims a method of treating cancer (breast, prostate, or ovary) by administering a Formula I compound (defined by broad substituent ranges for heteroaryl/aryl units and multiple variable groups, plus “optionally substituted” constraints) in combination with an antineoplastic agent (taxanes and a listed set of cytotoxics). Claims 2-17 narrow the Formula I substituent variables and provide extensive specific compound embodiments. Claims 18-26 further narrow the partner antineoplastic agent and the cancer selection. The estate is dominated by (1) the broad independent method claim to the combination regimen and (2) numerous dependent claims that likely expand enforceable coverage across multiple Formula I analogs and multiple oncology backbones.

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US Patent 10,456,392 scope and claims for method-of-treatment cancer regimen with Formula I compounds

US10,456,392 is an independent method-of-use claim anchored to (i) a Formula I small-molecule structure and (ii) a combination with an antineoplastic agent, applied to (iii) breast, prostate, and ovary cancer subsets. The claim architecture is typical of combination-dosing method patents: broad “core” coverage in Claim 1, followed by narrowing dependent claims to specific R-group subsets and specific exemplified compounds.

What is the core claim in US10,456,392?

Claim 1 requires all of the following elements:

1. A method of treating cancer in a subject in need.
2. Administration of a therapeutically effective amount of a Formula I compound.
3. Cancer is selected from:
   • breast cancer
   • prostate cancer
   • ovary cancer
4. The Formula I compound is administered in combination with an antineoplastic agent.
5. Formula I constraints include:
   • R1: extensive heteroaryl list (pyrrole, pyrazole, imidazole, triazoles, tetrazole, furan, oxazole, isoxazole, thiophene, thiazole, isothiazole, isoxazole, oxadiazoles, thiadiazoles, pyridines, pyrimidines, pyridazines, etc.)
   • R1 is optionally substituted with 1-4 groups selected from R1a (H, C1-6 alkyl, halogen, haloalkyl, alkoxy, haloalkoxy, —CN, N-oxide, cycloalkyl, heterocycloalkyl)
   • Ring J: cycloalkyl ring, heterocycloalkyl ring (5-6 members, 1-4 N/O/S), aryl ring, or heteroaryl ring with analogous member/heteroatom ranges
   • R2: large menu (H, alkyl, halogen, haloalkyl, alkoxy, haloalkoxy, alkyl-alkoxy, —CN, —OH, carbonyl/ester/amides/thiocarbonyl sulfoxide/sulfone variants, and cycloalkyl)
   • Alternative ring-closure options: “two R2 linked to same carbon” can form oxo (=O) or link to form heterocycloalkyl ring with additional substitution limits
   • R2a/R2b (H or C1-6 alkyl), R2c (H/halogen/hydroxy/alkoxy/—CN/—NR2aR2b), R2d (H or C1-6 alkyl or forms (═O))
   • R3: phenyl or pyridyl optionally substituted with 1-4 R3a (H/halogen/haloalkyl)
   • n = 0 to 3
   • salts of Formula I

Practical meaning for enforcement

Claim 1 is not limited to a single molecule. It covers a regimen where the administered compound falls anywhere within the Formula I substituent space. The claim is therefore highly sensitive to chemical identity matching by infringement analyses (Markman construction of Formula I variable definitions, then literal infringement or equivalence for substituted variants, plus treatment of “optionally substituted” constraints).

How do dependent claims narrow the Formula I scope?

Claims 2-17 progressively constrain Formula I:

• Claim 2: narrows R1 to a subset (e.g., removes many of the R1 options and keeps specified heterocycles such as pyrazoles, imidazoles, triazoles, furan, oxazole, oxadiazole, thiophene, thiazole, pyridine/pyrimidine).
• Claims 3-4: limit R1a substituents progressively:
  • Claim 3: R1a = H, alkyl, haloalkyl, alkoxy, heterocycloalkyl
  • Claim 4: R1a = H, methyl, ethyl, trifluoromethyl, methoxy
• Claims 5-9: constrain ring J progressively from “heterocycloalkyl/aryl/heteroaryl” down to specific ring types, culminating in:
  • Claim 8: ring J = phenyl
  • Claim 9: ring J = pyridyl
  • Claim 7 provides an explicit list including phenyl, pyridine, imidazole, pyrazole, triazole, tetrazole, thiadiazole, isothiazole, cyclohexyl, THF, and tetrahydro-2H-pyran.
• Claims 10-11: narrow R2 options:
  • Claim 10: broad list including —C(O)OR2a and —S(O)2R2a, plus alkoxy/haloalkoxy, etc.
  • Claim 11: R2 limited to H, methyl, ethyl, F, Cl, —CF3, OMe, OCHF2, —CN, —S(O)2Me
• Claim 12: locks R3 to 4-F-phenyl.
• Claims 13-17: provide extensive specific compound groupings. These are not merely exemplars; they function as dependent claims that likely map directly to particular salts/forms corresponding to those enumerated names.

Structural coverage signal

The claim set mixes:

• variable-structure (Markush) coverage for general scope (Claim 1)
• narrow-subset dependent Markush claims (Claims 2-12)
• compound-name dependent claims (Claims 13-17) that likely correspond to actual synthesized/intermediate-exemplified members, supporting robust obviousness and enablement narratives during prosecution.

How many distinct “Formula I embodiments” are claimed?

The independent claim is one, but dependent claims contain long enumerations of compound-specific members in Claims 13-17 (and additional narrowing in 14-16). Based on the text provided, these enumerations include dozens to over one hundred distinct Formula I molecules defined by combinations of:

• stereochemistry labels (e.g., “(R)-” prefacing)
• sulfonyl substituents (aryl sulfonyl variants including CF3-phenyl, F-phenyl, Cl-phenyl, methoxy phenyl, difluoro phenyl, tosyl, etc.)
• heteroaryl acyl fragments (pyridyl, imidazolyl, triazolyl, thiazolyl, oxazolyl, pyrazolyl, etc.)
• ring substitutions and alternative groups (e.g., picolinoyl-like moieties, difluoromethoxy, trifluoromethoxy)
• “tetrahydro-” bicyclic/condensed core variants reflected in the repeated scaffold naming

From a landscape standpoint, that breadth matters because it creates multiple targetable infringement points: a generic developer or licensee can’t argue “we use a different analog” without first mapping whether their analog is still inside the Markush scope or outside the enumerated dependent subsets.

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What patents protect combination cancer treatment using a Formula I compound plus listed antineoplastic agents?

The key is that US10,456,392 is not a pure compound patent. It is a combination method-of-use patent. It protects a regimen where:

• the Formula I compound is administered
• the antineoplastic agent is one of the listed cytotoxics
• cancer is restricted to breast, prostate, ovary

Which antineoplastic agents are explicitly listed?

Claims 18-26 specify antineoplastic agents:

• Taxanes:
  • taxanes, taxol, docetaxel, paclitaxel
• Actinomycin
  • actinomycin
• Anthracyclines
  • anthracyclines, doxorubicin, daunorubicin
• Other cytotoxics
  • valrubicin
  • bleomycin
  • cisplatin

This list is repeated across dependent claims, with slight coupling to particular claims:

• Claim 18: partner antineoplastic agent selection tied to Claim 1 generally
• Claims 19-24: repeat agent selection tied to specific earlier dependent claims (2, 12, 13, 14, 15, 16 respectively)
• Claim 25: Claim 1 narrowed to breast/ovary plus the agent list
• Claim 26: Claim 1 narrowed to prostate plus the agent list

Is the combination requirement likely interpreted broadly?

Claim 1 requires “administered in combination with an antineoplastic agent.” Given the claim format and list, the legally relevant questions typically include:

• whether “in combination” requires co-administration (simultaneous) versus sequential dosing
• whether “therapeutically effective amount” requires a specific dose range (not provided in your text)
• whether the antineoplastic agent includes branded or generic forms (the claim lists class names and known drugs, not active-ingredient-by-chemical-structure)

From a scope perspective, the claim language is broad because it does not specify:

• dosing interval
• route
• number of cycles
• ratio between agents

That breadth increases the chance of covering real-world oncology regimens that clinicians vary by protocol.

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Where is claim scope strongest: Formula I Markush variables or the combination/indication limits?

US10,456,392 has two “scope drivers”:

1) Strong driver: Formula I core breadth

Claim 1’s R1/R2/R3/Ring J permutations and alternatives (including ring-closure options) create a large chemical space. The more variants a competitor can practice without stepping outside Formula I, the more likely US10,456,392 captures combination regimens in practice.

2) Strong driver: indication and partner cytotoxics

The claim is limited to breast, prostate, ovary, and partner antineoplastics among a named list. That limitation can reduce coverage against:

• other cancers (e.g., lung, colorectal)
• other partner therapies (e.g., PARP inhibitors, AR pathway agents, immune checkpoint inhibitors, targeted therapies) unless separately covered by other patents or later claims.

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Which specific cancer types are covered and how do dependent claims narrow the indication?

• Claim 1: breast, prostate, ovary (three-item “selected from group”)
• Claim 25: breast or ovary only
• Claim 26: prostate only

This structure indicates enforcement can be pursued across:

• general breast/prostate/ovary combination therapy (Claim 1)
• narrower breast/ovary subsets (Claim 25)
• prostate-specific subset (Claim 26)

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What generic entry risks exist if a marketer uses a different Formula I analog within Claim 1’s variable ranges?

Because Claim 1 is Markush-defined for Formula I (with extensive permissible substitutions), a generic or follow-on developer’s main entry risks are:

Risk A: their compound still fits within Formula I

Even if their compound differs from an enumerated dependent embodiment, it may still fall inside Claim 1 if:

• their R1/R1a substitutions are still within allowed lists
• their ring J falls within allowed ring families and member/heteroatom counts
• their R2/R2c/R2d alternatives still match the carbonyl/oxo/ring-closure permitted patterns
• n falls between 0 and 3
• salts are included

Risk B: “design-around” through partner cytotoxic

Claim 1 requires combination with one of the listed cytotoxics. A competitor could attempt to avoid by pairing with an unlisted agent. The patent then becomes less relevant if the clinical program chooses unlisted partners. However, the dependent claims show multiple combinations with the same cytotoxic list across breast/prostate/ovary, suggesting the inventors anticipated a range of conventional oncology backbones.

Risk C: use outside the claimed cancer indications

If a competitor targets other cancers, the method claim may be non-infringing for those indications, even if the compound is the same. The risk is then shifted to other indication patents in the estate.

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How strong is the patent estate implied by the claim set structure (Markush + compound-specific dependents)?

Based on the claim scope you provided:

Likely strong features

• Broad independent method claim (Claim 1) with large structural tolerance for Formula I.
• Multiple “narrower” dependent claims that lock down subsets of R1a/R2/R3 and ring J, which can:
  • support multiple infringement theories
  • reduce the effectiveness of invalidity arguments targeted at one narrow embodiment
• Enumerated specific compound dependents (Claims 13-17) improve practical enforceability against infringement where the accused product matches an exemplified member.

Litigation posture implications

In infringement analysis, the combination method claim typically requires proof that:

• the accused regimen uses the claimed Formula I compound
• the patient population matches the claimed cancer indications
• the regimen includes one of the listed antineoplastic agents
• the dosage is “therapeutically effective” (usually satisfied by clinical dosing)

This creates multiple evidentiary pathways (labeling, clinical protocol, physician prescribing practices, NDC-level mapping for partner drugs).

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What formulations are protected by US10,456,392?

The claims you provided are method-of-treatment claims, not formulation claims. There are no explicit dosage form limitations in Claim 1 (e.g., oral, IV, particle size). Claims include “salts thereof,” but no excipients.

From a design-around perspective, the patent likely covers the act of administering the covered compound in combination, regardless of how the drug is formulated, provided it is still the claimed chemical entity and used in the claimed combination regimen.

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When does US10,456,392 lose exclusivity?

No prosecution or priority/filing dates were provided in your prompt. Without those, the USPTO term expiration calculation cannot be performed from the information given.

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Key Takeaways

• Claim 1 covers cancer treatment in breast, prostate, ovary using a Formula I compound in combination with one of the listed cytotoxics.
• The Formula I definition is the breadth driver, with extensive permissible heteroaryl/aryl choices (R1), optional substitutions (R1a), ring J families, and detailed R2 alternatives including carbonyl/oxo and ring-closure options.
• Dependent claims narrow R1/R1a, ring J, R2, and R3, then add extensive specific compound embodiments, creating multiple infringement hooks.
• The combination partner list is limited to a discrete set (taxanes, doxorubicin/daunorubicin and other anthracyclines, actinomycin, valrubicin, bleomycin, cisplatin). Avoiding the claim likely requires changing the partner regimen and/or the cancer indication, not merely altering the molecule slightly.
• The estate strength implied by the claim set is high for regimen coverage but constrained to the indication and partner-agent boundaries.

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FAQs

1) Does US10,456,392 cover use with PARP inhibitors or immunotherapy?

The claims provided require “in combination with an antineoplastic agent” selected from the explicit list in dependent claims (taxanes, taxol/docetaxel/paclitaxel, actinomycin, anthracyclines/doxorubicin/daunorubicin, valrubicin, bleomycin, cisplatin). Coverage for other oncology agents is not established by the provided claim text.

2) If a competitor uses a Formula I analog not listed in Claims 13-17, can it still infringe Claim 1?

Yes. Claim 1 is Markush-defined for Formula I and can cover analogs that fit the variable ranges even if they are not enumerated in dependent compound lists.

3) Can a competitor avoid infringement by using a different cancer than breast/prostate/ovary?

Yes for the method claim at issue, because Claim 1 restricts the cancer to breast, prostate, and ovary, with dependent claim subsets for breast/ovary and prostate.

4) Are salts protected?

Claim 1 includes “or salts thereof,” so salt forms of covered Formula I compounds are within the claim language.

5) Are there any dosage-form constraints (oral vs IV) in US10,456,392?

No dosage-form limitations are present in the claim text you provided; it is a method-of-treatment claim focused on administering the compound in combination.

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References

1. United States Patent 10,456,392 (claims provided in user prompt).

Drugs Protected by US Patent 10,456,392

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						TREATMENT OF PLATINUM-RESISTANT EPITHELIAL OVARIAN CANCER WITH LIFYORLI IN COMBINATION WITH NAB-PACLITAXEL, IN ADULTS WHO HAVE RECEIVED ONE TO THREE PRIOR SYSTEMIC TREATMENT REGIMENS, AT LEAST ONE OF WHICH INCLUDED BEVACIZUMAB

International Family Members for US Patent 10,456,392

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013266110
Brazil	112014028857
Brazil	112015022109