Details for Patent: 10,905,690

Which drugs does patent 10,905,690 protect, and when does it expire?

Patent 10,905,690 protects CRENESSITY and is included in two NDAs.

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

Summary for Patent: 10,905,690

Title:	Treatment of congenital adrenal hyperplasia
Abstract:	CRF1 receptor antagonists have the potential to directly inhibit ACTH release in patients with CAH and thereby allow normalization of androgen production while using lower, more physiologic doses of hydrocortisone, and thus reducing treatment-associated side effects.
Inventor(s):	Dimitri E. Grigoriadis
Assignee:	Neurocrine Biosciences Inc
Application Number:	US16/227,127
Patent Claim Types: see list of patent claims	Use;

US Patent 10,905,690: Claim Scope, Exclusivity, and Congenital Adrenal Hyperplasia Patent Landscape

US Patent 10,905,690 protects a narrow method of treating congenital adrenal hyperplasia, or CAH, with the specific CRF1 receptor antagonist SSR-125543. The broadest claim is limited by three elements: the disease, administration of a CRF1 antagonist, and the identity of that antagonist. The dependent claims add timing limitations tied to bedtime and the expected circadian ACTH surge.

The patent does not broadly cover every CRF1 antagonist, every CAH treatment, or every formulation. Its commercial significance depends on whether SSR-125543 is developed, approved, supplied, or used for CAH in the United States. Because SSR-125543 is not the active ingredient in the FDA-approved CAH therapy Crenessity, the patent does not directly read on crinecerfont products. [1-3]

What does US Patent 10,905,690 claim?

The patent’s operative independent claim is claim 1:

A method of treating CAH by administering an effective amount of a CRF1 receptor antagonist, where the antagonist is SSR-125543 or a pharmaceutically acceptable salt.

The claim contains the following required limitations:

Claim element	Scope
Disease	Congenital adrenal hyperplasia
Activity	Treatment of a subject in need
Agent class	CRF1 receptor antagonist
Required molecule	SSR-125543
Chemical form	SSR-125543 or a pharmaceutically acceptable salt
Dose	“Effective amount,” without a fixed numerical dose
Route	Not limited
Patient population	Not limited by age, sex, genotype, or CAH subtype

The reference to a CRF1 receptor antagonist does not create a broad genus claim. The following phrase limits the claim to the specifically identified molecule:

“wherein the CRF1 receptor antagonist is” SSR-125543 or a pharmaceutically acceptable salt.

A product using another CRF1 antagonist, such as crinecerfont or tildacerfont, would not literally satisfy the active-agent limitation merely because it acts on the same receptor.

How broad is claim 1 of US 10,905,690?

Claim 1 is chemically narrow but operationally broad.

It is chemically narrow because it covers one identified antagonist and its pharmaceutically acceptable salts. It does not cover all compounds that inhibit CRF1.

It is operationally broad because it does not specify:

• a dose;
• dosage frequency;
• oral, injectable, or other route;
• formulation;
• treatment duration;
• cortisol or ACTH threshold;
• CAH subtype;
• adrenal steroid replacement regimen;
• use with glucocorticoids or mineralocorticoids;
• age or sex of the patient;
• inpatient or outpatient treatment;
• clinical endpoint.

A party could potentially practice claim 1 through many different dosing regimens if it administers SSR-125543 for CAH. The absence of dose and route limitations increases the practical reach of the claim once the molecule is used clinically.

The claim remains vulnerable to validity attacks directed at anticipation or obviousness. Relevant prior art would include disclosures of SSR-125543, CRF1 antagonism, HPA-axis modulation, ACTH suppression, and treatment of CAH or related adrenal disorders. The key issue would be whether the prior art disclosed the claimed combination, not merely whether it disclosed the compound or CRF1 antagonism separately.

What do claims 2, 3, and 4 protect?

Claims 2 through 4 protect chronobiological dosing schedules.

Claim	Added limitation	Practical meaning
2	Administration at bedtime	Covers bedtime dosing, without defining a clock time
3	Administration at or before expected circadian ACTH release	Links dosing to the patient’s anticipated ACTH rhythm
4	Administration 3-4 hours before expected circadian ACTH release	Creates a more specific pre-ACTH window

Claim 4 is narrower than claim 3. It requires administration 3-4 hours before the expected circadian ACTH release. Claim 3 covers that window and other administration times occurring at or before the expected ACTH release.

Claim 2 is not necessarily coextensive with claim 4. Bedtime may occur 3-4 hours before ACTH release for some patients, but the claim does not require that relationship. A bedtime regimen could fall outside the claim 4 window.

The timing claims may be commercially important because they can create infringement risk even where a competitor uses the same molecule under a different general treatment label. Their enforceability would depend on whether the prescribing information, protocol, clinical instructions, or actual administration records establish the claimed timing.

What does claim 5 add?

Claim 5 removes the salt alternative and recites the named SSR-125543 molecule itself.

As a dependent claim, claim 5 includes all limitations of claim 1 and confirms coverage of the non-salt chemical entity. It is narrower than claim 1 because claim 1 also covers pharmaceutically acceptable salts.

Claim 5 may have value if a defendant contests whether a particular salt is pharmaceutically acceptable or whether the administered form converts to the free base in vivo. It does not expand the patent beyond SSR-125543.

What patents protect SSR-125543 and CAH treatment?

US 10,905,690 is a use patent. Its principal exclusionary right is directed to treating CAH with SSR-125543, rather than to the compound as a chemical entity in all fields of use.

A complete freedom-to-operate review should separate the patent landscape into five groups:

Patent category	Relevance to SSR-125543
Compound patents	May cover SSR-125543 itself, stereochemistry, salts, solvates, and chemical intermediates
CAH method patents	May cover treatment of CAH with SSR-125543 or other CRF1 antagonists
Regimen patents	May cover bedtime or pre-ACTH dosing
Formulation patents	May cover tablets, capsules, modified release, suspensions, or injectable products
Manufacturing patents	May cover synthesis, purification, polymorphs, or chiral resolution

US 10,905,690 does not, based on the supplied claims, include express limitations for a particular formulation, polymorph, manufacturing process, or dosage form. Those rights would need to arise from separate patents or unasserted claims in the same family.

The patent also does not establish ownership of the underlying SSR-125543 compound. A compound patent, if still enforceable, could create a separate barrier even when the use patent expires.

When does US Patent 10,905,690 lose exclusivity?

US Patent 10,905,690 was issued on February 2, 2021. The ordinary US patent term is generally 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any patent-term extension. [1]

The patent’s expected statutory expiration is approximately in 2036 if its earliest effective filing date was in 2016. The exact expiration date should be taken from the USPTO patent-term calculation and the patent’s continuity data. Patent-term adjustment could move the date later, while a terminal disclaimer could limit it.

The patent does not appear to provide an immediately relevant Hatch-Waxman exclusivity period because SSR-125543 is not identified here as an FDA-approved active ingredient. Patent exclusivity and regulatory exclusivity are separate rights. A patent can remain enforceable without generating an Orange Book-listed drug product.

What is the Orange Book status of US 10,905,690?

US 10,905,690 is not, by itself, an Orange Book listing. The Orange Book lists patents submitted by sponsors for approved drug products, including certain drug substance, drug product, and method-of-use patents. [2]

The patent would become relevant to an abbreviated new drug application only if:

1. SSR-125543 were approved as an FDA drug product;
2. the sponsor submitted the patent for listing;
3. the FDA accepted the listing under applicable Orange Book rules; and
4. the listed claims covered the approved product or an approved method of use.

Absent an approved SSR-125543 product and a qualifying listing, there is no conventional Paragraph IV pathway directed specifically to this patent. An ANDA applicant could still raise invalidity or noninfringement arguments in a regulatory or commercial setting, but the statutory Paragraph IV litigation framework depends on a listed patent.

Does the patent cover Crenessity or crinecerfont?

No literal coverage can be established from the supplied claims for Crenessity, whose active ingredient is crinecerfont.

Crenessity was approved by the FDA for reducing excess adrenal androgen production in adults and children with CAH. Its active ingredient is crinecerfont, a CRF1 antagonist, but it is not SSR-125543. [3]

Product or compound	CRF1 activity	Literal coverage under claim 1
SSR-125543	Yes	Yes, if used to treat CAH
SSR-125543 pharmaceutically acceptable salt	Yes	Yes
Crinecerfont	Yes	No, based on the claim language
Tildacerfont	Yes	No, based on the claim language
Unrelated CRF1 antagonist	Potentially	No, unless it is SSR-125543

The doctrine of equivalents could be asserted in some circumstances, but it cannot be assumed. A different CRF1 antagonist would present substantial noninfringement arguments because the patent expressly identifies a particular chemical structure. Prosecution-history estoppel, foreseeability, vitiation, and the scope of any prior-art disclaimer would be material.

What formulation patents are protected by US 10,905,690?

None are expressly recited in the supplied claims.

The patent covers SSR-125543 in a method of treatment and allows a pharmaceutically acceptable salt. It does not specify:

• immediate-release tablets;
• extended-release tablets;
• capsules;
• liquid formulations;
• injectable formulations;
• particle-size distributions;
• crystalline forms;
• amorphous forms;
• excipient combinations;
• bioavailability targets;
• food-effect conditions.

A commercial SSR-125543 product could therefore require separate formulation and solid-state patents. Those patents could extend practical market protection beyond the expiry of a compound patent or could create additional litigation exposure before the use patent expires.

Are there method-of-use patents for circadian ACTH control?

US 10,905,690 is itself a method-of-use patent directed to CAH and circadian timing. Claims 2-4 create distinct claim positions around the time of administration.

The strongest infringement theory would involve a product label or clinical protocol that expressly instructs:

• bedtime administration;
• administration before the expected ACTH rise; or
• administration 3-4 hours before the expected ACTH rise.

A label that merely identifies CAH as an indication but does not instruct the patented timing may create a weaker induced-infringement case. The analysis would turn on the full label, promotional materials, physician instructions, and evidence of intended use. The Federal Circuit has treated label-based induced infringement as fact-specific, particularly where a label includes both infringing and noninfringing uses. [4]

Which companies are challenging the patent?

The supplied information does not identify a Paragraph IV notice, district-court complaint, inter partes review, post-grant review, or settlement involving US 10,905,690.

The patent’s practical litigation exposure appears lower than that of a listed patent covering an approved blockbuster product because SSR-125543 is not identified as an approved commercial active ingredient. The principal risk would arise if a sponsor advanced SSR-125543 into clinical development or approval for CAH, or if a third party marketed the compound for CAH in a manner that met the claims.

No settlement agreement or license can be inferred from the patent claims. Any asserted license, assignment, or collaboration would need to be confirmed through USPTO assignment records, SEC filings, clinical-development disclosures, or court records.

How strong is the patent estate?

The patent is strong against the specific commercial use stated in the claims if SSR-125543 is administered for CAH during the patent term. It is weaker as a platform patent.

Strength factor	Assessment
Chemical specificity	Narrow; limited to SSR-125543 and salts
Disease scope	Broad across CAH subtypes unless limited elsewhere
Dose limitations	None in claim 1
Route limitations	None
Timing protection	Meaningful in claims 2-4
Formulation protection	Not shown
Compound protection	Not established by the supplied claims
Biosimilar relevance	None directly
Generic relevance	Relevant only to an SSR-125543 product
Orange Book leverage	Dependent on FDA approval and listing
Design-around potential	High through a different CRF1 antagonist

The patent’s value is therefore concentrated. It could be important to an SSR-125543 CAH program, but it does not materially constrain competing CRF1 antagonists unless separate patents cover those molecules or their regimens.

What generic launch risks exist?

A generic or follow-on applicant for an SSR-125543 product would face several possible barriers:

1. A compound patent, if still in force.
2. US 10,905,690, if the product is labeled for CAH.
3. Separate formulation or solid-state patents.
4. Manufacturing patents.
5. Patent-term adjustment or extension.
6. Label-based induced-infringement exposure.

A skinny-label strategy could attempt to omit CAH or the patented timing regimen. That strategy would be less useful if the product’s clinical use, marketing, or prescribing instructions still encourage CAH treatment. The feasibility of a carve-out would depend on the approved labeling and the exact Orange Book listing.

What is the competitive patent landscape for CAH therapies?

The CAH market includes conventional glucocorticoid and mineralocorticoid replacement, CRF1 antagonists, and emerging endocrine therapies. Crinecerfont has regulatory relevance because it is an approved CRF1 antagonist for CAH, but it is chemically distinct from SSR-125543. [3]

The main competitive distinction is:

Program type	Relationship to US 10,905,690
SSR-125543 CAH therapy	Directly within the claim scope
Crinecerfont CAH therapy	Outside the literal compound limitation
Tildacerfont CAH therapy	Outside the literal compound limitation
Conventional steroid replacement	Outside the CRF1 antagonist limitation
New non-CRF1 CAH therapy	Outside the claim unless another legal theory applies

Biosimilar risk is not applicable in the ordinary sense because SSR-125543 is a small molecule, not a biologic. The relevant competitors would be generics, new chemical entities, or other small-molecule endocrine therapies.

Key Takeaways

• US 10,905,690 is a narrow method patent centered on SSR-125543 for CAH.
• Claim 1 covers SSR-125543 and pharmaceutically acceptable salts, without limiting dose, route, or treatment duration.
• Claims 2-4 protect bedtime and pre-circadian-ACTH administration schedules.
• Claim 5 expressly recites the SSR-125543 free-base structure.
• The claims do not cover CRF1 antagonists generally.
• Crinecerfont and tildacerfont are outside the literal scope based on the supplied claim language.
• The patent does not itself establish formulation, manufacturing, compound, or solid-state protection.
• Orange Book and Paragraph IV relevance depend on FDA approval and listing of an SSR-125543 product.
• The expected patent term reaches approximately 2036, subject to the official USPTO term calculation.
• The commercial value is concentrated in an SSR-125543 CAH program rather than the broader CRF1 antagonist market.

FAQs About US Patent 10,905,690

Does US 10,905,690 cover all CRF1 antagonists for CAH?

No. The claims identify SSR-125543 specifically. Another CRF1 antagonist would not literally satisfy the active-agent limitation.

Does the patent cover crinecerfont?

No, not literally based on the supplied claims. Crinecerfont is a different chemical entity from SSR-125543.

Can a company avoid claim 4 by dosing at bedtime?

Potentially. Bedtime dosing is separately addressed in claim 2, while claim 4 requires administration 3-4 hours before the expected circadian ACTH release. The actual schedule and evidence of administration would control.

Is US 10,905,690 a patent for a drug product?

No. It is a method-of-treatment patent. The supplied claims do not recite a tablet, capsule, injectable product, formulation, or manufacturing process.

Would a generic SSR-125543 applicant automatically face a Paragraph IV lawsuit?

No. Paragraph IV exposure generally requires a qualifying Orange Book-listed patent associated with an approved reference product. The patent’s existence alone does not create an automatic Paragraph IV case.

References

1. United States Patent and Trademark Office. (2021). United States Patent No. 10,905,690, Methods of treating congenital adrenal hyperplasia.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2024). Crenessity (crinecerfont) prescribing information.
4. U.S. Court of Appeals for the Federal Circuit. (2015). Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920.

Drugs Protected by US Patent 10,905,690

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No	10,905,690					ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-002	Dec 13, 2024		RX	Yes	No	10,905,690					ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-003	Dec 13, 2024		RX	Yes	Yes	10,905,690					ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)
Neurocrine	CRENESSITY	crinecerfont	SOLUTION;ORAL	218820-001	Dec 13, 2024		RX	Yes	Yes	10,905,690					ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)

International Family Members for US Patent 10,905,690

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015209452
Australia	2020207774
Australia	2022263460
Australia	2024219813
Brazil	112016016975