Details for Patent: 9,717,740

Which drugs does patent 9,717,740 protect, and when does it expire?

Patent 9,717,740 protects ALKINDI SPRINKLE and is included in one NDA.

This patent has twenty-six patent family members in twenty-one countries.

Summary for Patent: 9,717,740

Title:	Treatment of adrenal insufficiency
Abstract:	The disclosure relates to the treatment of adrenal insufficiency with particular but not limiting application to pediatric treatment regimens, the treatment of the elderly and non-human animals.
Inventor(s):	Hiep Huatan, Richard Ross, Martin Whitaker
Assignee:	Neurocrine Uk Ltd
Application Number:	US15/473,724
Patent Claim Types: see list of patent claims	Use; Dosage form;

US Patent 9,717,740: Hydrocortisone Microparticle Claims, Exclusivity, and Generic Risk

US Patent 9,717,740 protects a specific multiparticulate hydrocortisone delivery system used to treat adrenal insufficiency. The patent is assigned to Diurnal Limited and is associated with Alkindi Sprinkle, an FDA-approved hydrocortisone product containing taste-masked granules for pediatric patients.

The core claim is a method-of-treatment claim. Infringement requires use of an oral dosage form containing hydrocortisone multilayer microparticles with the claimed core, sealing layer, active layer, and taste-masking exterior layer. The patent does not broadly cover every hydrocortisone product, every adrenal-insufficiency treatment, or every modified-release formulation.

Based on the patent’s priority and filing history, the nominal US patent term extends into December 2032, subject to any patent-term adjustment and terminal disclaimer reflected in the official USPTO record. The FDA product most closely associated with the patent is Alkindi Sprinkle, approved in 2020 for replacement therapy in pediatric patients with adrenocortical insufficiency.

What does US Patent 9,717,740 protect?

US 9,717,740 protects the use of hydrocortisone-containing multilayer microparticles in pediatric or elderly patients with adrenal insufficiency. The independent claim requires all of the following elements:

Required element	Claim 1 requirement
Patient	Pediatric or elderly human
Condition	Adrenal insufficiency
Administration	Oral administration
Dosage form	Oral dosage form containing multiple hydrocortisone microparticles
Core	Inert core consisting essentially of microcrystalline cellulose
Sealing layer	Hydroxypropyl methylcellulose and magnesium stearate
Active layer	Hydrocortisone and hydroxypropyl methylcellulose
Layer arrangement	Active layer between the core and sealing layer
Exterior layer	Hydroxypropyl methylcellulose and ethyl cellulose
Function	Exterior layer provides taste masking
Dose	Therapeutically effective amount of hydrocortisone

The claim is narrow in composition but broad in dosage-form presentation. Claims 3 through 6 extend coverage to tablets, capsules, liquids, suspensions, foodstuffs, drinks, and immediate-release dosage forms.

The claim also covers multiple adrenal-insufficiency conditions, including primary, secondary, and tertiary adrenal failure; congenital adrenal hyperplasia; late-onset congenital adrenal hyperplasia; congenital adrenal dysfunction; polycystic ovarian failure; and glucocorticoid-remediable aldosteronism.

How strong is the independent claim?

The principal claim has meaningful commercial value because it combines a patient population, a therapeutic indication, and a highly specified microparticle architecture.

Its strength comes from the cumulative formulation limitations:

1. Microcrystalline cellulose core.
2. HPMC and magnesium stearate sealing layer.
3. Hydrocortisone/HPMC active layer.
4. HPMC/ethyl cellulose taste-masking layer.
5. Oral administration for adrenal insufficiency.
6. Pediatric or elderly patient.

A competing product must avoid at least one required limitation to avoid literal infringement. A generic applicant could pursue a formulation using a different core material, omit magnesium stearate from the sealing layer, use a different polymer in the active layer, or use an alternative taste-masking coating.

The claim is therefore stronger against a close copy of the Alkindi Sprinkle formulation than against conventional hydrocortisone tablets, compounded suspensions, uncoated granules, or products using a materially different multiparticulate design.

What does “consisting essentially of” mean for the core?

The inert core must consist essentially of microcrystalline cellulose. This language generally permits additional ingredients if they do not materially affect the basic and novel characteristics of the claimed core. The phrase creates more flexibility than “consisting of,” but less than “comprising.”

A product using sugar spheres, starch pellets, silica particles, or another non-cellulosic inert carrier would present a stronger non-infringement position. A product using microcrystalline cellulose with minor conventional excipients would require a fact-specific analysis.

What do the dependent claims add?

The dependent claims define narrower commercial embodiments and create fallback positions if the broader claim is challenged.

Claims	Added limitation
2	Hydrocortisone is about 0.65% by weight
3	Tablet, capsule, or liquid
4	Suspension
5	Foodstuff or drink
6	Immediate-release dosage form
7	Specified adrenal-failure conditions
8	Congenital adrenal dysfunction
9	Particle diameter of 100 to 1,200 micrometers
10	Particle diameter of 400 to 1,000 micrometers
11	Active-layer HPMC at 0.60% to 0.70% by weight
12	Active-layer HPMC at about 0.65% by weight
13	Hydrocortisone dose of 0.25 mg to 30 mg
14	Specific doses from about 0.25 mg to 30 mg
15	Sealing layer at 25% to 35% by weight
16	Sealing layer at about 30% by weight
17	Exterior taste-masking layer at 0.5% to 2.5% by weight
18	Exterior layer at about 2% by weight
19	Exterior-layer HPMC at 0.25% to 0.35% by weight
20	Exterior-layer ethyl cellulose at 1% to 2% by weight
21	Exterior-layer HPMC at about 0.3% and ethyl cellulose at about 1.2%

The claims directed to particle size, polymer percentages, and coating weight percentages are particularly relevant to formulation reverse engineering. A generic applicant could attempt to design around these numerical limitations while retaining the overall clinical concept.

What patents protect Alkindi Sprinkle?

US Patent 9,717,740 is the principal patent identified with the claimed hydrocortisone microparticle architecture. The product’s regulatory protection also depends on FDA exclusivity, any additional Orange Book-listed patents, and other members of the patent family.

Item	Status or relevance
Patent	US 9,717,740
Title	Hydrocortisone formulations
Assignee	Diurnal Limited
Technology	Taste-masked hydrocortisone multilayer microparticles
FDA product association	Alkindi Sprinkle
Dosage form	Hydrocortisone granules administered from capsules
Patient focus	Pediatric adrenal insufficiency
Nominal patent term	Into December 2032, subject to USPTO term adjustment
Patent type	Method of treatment with formulation limitations
Product class	Small-molecule drug, not a biologic

The full Orange Book position should be checked against the current FDA Orange Book patent listing and the product’s latest FDA labeling. Orange Book status can change through patent-listing updates, delistings, litigation certifications, and regulatory amendments. Patent-family members in Europe and other jurisdictions do not automatically create US exclusivity.

When does US Patent 9,717,740 expire?

The patent has a priority date in December 2011 and a US term that runs nominally to December 2032 under the standard 20-year term rules applicable to the relevant application chain. The precise expiration date depends on the effective US filing date, any patent-term adjustment, and whether a terminal disclaimer applies.

For commercial planning, the relevant conclusion is that the patent estate extends beyond the FDA’s pediatric exclusivity period and remains potentially relevant to generic entry through 2032.

A patent expiration estimate should not be confused with regulatory exclusivity:

Protection	Commercial effect
US patent	Can support infringement litigation and block or delay a close-copy product
FDA new-drug exclusivity	Restricts certain FDA approvals for a defined period
Pediatric exclusivity	Adds six months to qualifying regulatory exclusivities, not normally to the patent term
Orphan-drug exclusivity	May restrict approval of the same drug for the same disease or condition
Orange Book listing	Enables statutory patent certifications and potential ANDA litigation

What is the FDA regulatory status of the covered product?

The product most closely aligned with the claimed technology is Alkindi Sprinkle, a hydrocortisone product approved by FDA in 2020 for replacement therapy in pediatric patients with adrenocortical insufficiency. The product contains hydrocortisone granules inside capsules. The capsule is opened and the granules are administered directly into the child’s mouth or sprinkled onto a small amount of soft food, according to the FDA-approved labeling.

The formulation is intended to address problems associated with pediatric hydrocortisone administration, including dose flexibility, swallowing difficulty, and the bitter taste of hydrocortisone. The FDA label identifies strengths of 0.5 mg, 1 mg, 2 mg, and 5 mg per capsule, while the patent claims cover a broader dose range extending to 30 mg.[1]

The patent claims reach elderly patients as well as pediatric patients, but the FDA product’s principal commercial positioning is pediatric adrenal insufficiency. A method claim covering elderly patients may have limited practical value unless a marketed product is actually used in that population with the claimed microparticle structure.

How does the patent relate to the Alkindi formulation?

The claimed architecture closely tracks a taste-masked, immediate-release multiparticulate product:

• The microcrystalline cellulose core provides a carrier substrate.
• The hydrocortisone/HPMC active layer carries the drug.
• The HPMC/magnesium stearate sealing layer separates and stabilizes the active layer.
• The HPMC/ethyl cellulose exterior layer reduces exposure to the bitter active ingredient.
• The particle-size ranges support administration as granules rather than as a conventional tablet.

The claim does not require sustained release. Claim 6 expressly covers an immediate-release dosage form. The protection therefore focuses on palatability, dose flexibility, and administration of hydrocortisone microparticles rather than on delayed or chronically extended drug release.

What generic entry risks exist?

Generic entry would most likely proceed through an abbreviated new drug application if the proposed product can establish pharmaceutical equivalence and bioequivalence to the relevant reference product. The product is a small molecule, so biosimilar approval under the Public Health Service Act is not the appropriate pathway.

Potential entry routes include:

Entry route	Risk to patent holder
Close-copy hydrocortisone granules	High risk of a formulation and method-of-use challenge
Conventional hydrocortisone tablet	Lower risk under this patent, but may not be therapeutically substitutable for Alkindi
Uncoated hydrocortisone granules	Possible design-around, subject to taste-masking and other patent claims
Different inert core	Potentially strong non-infringement position
Different coating polymers	Potentially avoids literal infringement
Compounded pediatric suspension	Regulatory and quality limitations, but may avoid the claimed structure
Alternative multiparticulate technology	Depends on the exact excipient and layer composition

An ANDA applicant certifying that the patent is invalid, unenforceable, or not infringed would typically file a Paragraph IV certification if the patent is listed in the Orange Book. The patent holder could then bring an infringement action under 35 U.S.C. § 271(e)(2). A timely action can trigger a statutory stay of FDA approval for up to 30 months, subject to statutory exceptions and court developments.[2]

No conclusion about a Paragraph IV challenge should be drawn solely from the existence of the patent. A certification may be filed confidentially and may not become public until litigation is initiated or other disclosure occurs.

Are there biosimilar risks for hydrocortisone?

There is no conventional biosimilar pathway for hydrocortisone because hydrocortisone is a chemically synthesized small molecule. Competitive risk comes from generic hydrocortisone products, 505(b)(2) applications, compounded preparations, and alternative pediatric delivery systems.

A 505(b)(2) applicant could rely partly on FDA findings for an existing hydrocortisone product while introducing a new dosage form, strength, or administration method. Such an applicant would still need to address listed patents and applicable method-of-use protections.

The most direct competitive threat is therefore an ANDA or 505(b)(2) product that replicates the clinical utility of pediatric hydrocortisone granules while changing one or more claimed formulation components.

Which companies are challenging US 9,717,740?

Publicly available information does not establish a definitive active Paragraph IV challenger or a final judgment invalidating US 9,717,740. The absence of a publicly reported challenge does not prove that no certification has been filed.

The relevant potential challengers are generic manufacturers with pediatric hydrocortisone capabilities, including companies active in oral multiparticulate dosage forms, pediatric liquids, and specialty endocrine products. A company would face a higher litigation risk if its product used:

• Microcrystalline cellulose cores;
• HPMC and magnesium stearate as a sealing layer;
• HPMC in the hydrocortisone layer;
• HPMC and ethyl cellulose in an external taste-masking layer; and
• the claimed particle-size and composition ranges.

What manufacturing and intellectual-property barriers apply?

The patent creates a formulation barrier, but it does not independently protect every manufacturing step. The commercial difficulty lies in reproducing consistent multilayer particles at small hydrocortisone loadings while maintaining dose uniformity, coating integrity, acceptable dissolution, and taste masking.

The most sensitive manufacturing variables include:

1. Uniform deposition of the hydrocortisone active layer.
2. Control of the active-layer HPMC concentration.
3. Formation of the sealing layer at approximately 30% of particle weight.
4. Application of the thin HPMC/ethyl cellulose exterior layer.
5. Particle-size control between 100 and 1,200 micrometers.
6. Prevention of agglomeration and dose segregation.
7. Consistent release after sprinkling onto food or administration directly to the mouth.

A design-around may avoid literal infringement but still require substantial development work to meet FDA specifications. Formulation patents therefore create both a legal barrier and a process-development barrier.

How does this patent compare with conventional hydrocortisone products?

Attribute	US 9,717,740 formulation	Conventional hydrocortisone tablet
Dosage technology	Multilayer microparticles	Compressed tablet
Taste masking	Required exterior HPMC/ethyl cellulose layer	Usually limited or absent
Pediatric administration	Designed for granules and flexible administration	May require swallowing or manipulation
Release profile	Includes immediate-release embodiments	Usually immediate release
Core material	Microcrystalline cellulose	Tablet excipients
Patent risk under 9,717,740	Higher if all layers are replicated	Generally lower
Regulatory substitution	Product-specific	Not necessarily substitutable for granules
Main commercial advantage	Pediatric usability and dose flexibility	Established, low-cost oral dosage form

The patent’s commercial value is concentrated in pediatric delivery. It is less likely to block ordinary adult hydrocortisone tablets or unrelated hydrocortisone dosage forms.

What is the revenue exposure associated with the patent?

The patent’s revenue exposure is primarily tied to Alkindi Sprinkle and any follow-on products using the same multiparticulate platform. Public company disclosures do not isolate revenue attributable solely to US Patent 9,717,740.

Revenue risk depends on:

• The size of the US pediatric adrenal-insufficiency market.
• The ability of generic products to demonstrate equivalent administration and performance.
• Whether a challenger offers a lower-cost product that physicians consider interchangeable.
• The patent status of additional listed patents.
• The availability and acceptance of compounded hydrocortisone formulations.
• Reimbursement coverage for the branded product.

Because the patent is formulation-specific, a successful design-around could reduce the patent holder’s exclusivity without eliminating competition barriers created by regulatory requirements, manufacturing complexity, or other patents.

What is the overall patent strength?

US 9,717,740 is a moderately strong formulation patent against a close copy and a weaker barrier against technically distinct hydrocortisone products.

Factor	Assessment
Claim specificity	High
Breadth against all hydrocortisone products	Low
Protection against close Alkindi-type copies	High
Design-around difficulty	Moderate
Method-of-treatment limitation	Narrows enforceability to covered use
Pediatric commercial relevance	High
Adult commercial relevance	Limited
Small-molecule generic exposure	Material
Biosimilar exposure	Not applicable
Expected exclusivity horizon	Through approximately 2032, subject to official term data

The principal weakness is the number of formulation elements that must be proven. The principal strength is that the elements collectively describe the product’s commercially important architecture.

Key Takeaways

• US 9,717,740 covers oral treatment of adrenal insufficiency using hydrocortisone multilayer microparticles.
• The claim requires a microcrystalline cellulose core, HPMC/magnesium stearate sealing layer, hydrocortisone/HPMC active layer, and HPMC/ethyl cellulose taste-masking layer.
• The patent is closely associated with Alkindi Sprinkle and has its greatest commercial relevance in pediatric adrenal insufficiency.
• The nominal US term extends into December 2032, subject to official USPTO term adjustment and disclaimer data.
• A conventional hydrocortisone tablet is less likely to infringe than a close-copy granule product.
• Generic competition would proceed through an ANDA or, for a novel dosage form, potentially a 505(b)(2) application.
• Hydrocortisone is a small molecule, so biosimilar litigation is not the relevant competitive framework.
• The patent is strongest against products reproducing the same multilayer microparticle design and weaker against products using different cores, polymers, or delivery technologies.
• Publicly available information does not establish a final invalidity judgment or confirmed active Paragraph IV challenger against this patent.

Frequently Asked Questions

Does US 9,717,740 cover all pediatric hydrocortisone products?

No. The product must use the claimed multilayer microparticle structure and must be administered orally to a pediatric or elderly patient for adrenal insufficiency.

Can a generic avoid the patent by changing the particle size?

Possibly, but particle size is only one limitation. The product would also need to avoid the required core, active layer, sealing layer, exterior layer, and other claim elements.

Does the patent cover hydrocortisone liquid formulations?

Potentially. Claim 3 expressly includes liquids, and claim 4 includes suspensions. The liquid or suspension must still contain the claimed hydrocortisone multilayer microparticles.

Is Alkindi Sprinkle protected by orphan-drug exclusivity?

Alkindi Sprinkle received FDA approval for pediatric adrenal insufficiency. Any orphan-drug exclusivity must be evaluated separately from patent protection and against the FDA’s product-specific exclusivity records.

Can a compounded hydrocortisone suspension infringe this patent?

A compounded product could infringe if it uses the claimed microparticles and is administered for the claimed treatment. A conventional suspension without the claimed multilayer particles would generally present a lower risk under this patent.

References

1. U.S. Food and Drug Administration. (2020). Alkindi Sprinkle (hydrocortisone) oral granules: Prescribing information. FDA.
2. U.S. Patent No. 9,717,740. (2017). Hydrocortisone formulations. United States Patent and Trademark Office.
3. United States Code, 35 U.S.C. § 271(e)(2). (2024). Infringement related to submission of an abbreviated new drug application.
4. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation. USPTO.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

Drugs Protected by US Patent 9,717,740

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-001	Sep 29, 2020		RX	Yes	No						TREATMENT OF ADRENAL INSUFFICIENCY
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-002	Sep 29, 2020		RX	Yes	No						TREATMENT OF ADRENAL INSUFFICIENCY
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-003	Sep 29, 2020		RX	Yes	No						TREATMENT OF ADRENAL INSUFFICIENCY
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-004	Sep 29, 2020		RX	Yes	Yes						TREATMENT OF ADRENAL INSUFFICIENCY

Foreign Priority and PCT Information for Patent: 9,717,740

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1119985.8	Nov 19, 2011

International Family Members for US Patent 9,717,740

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012338583
Brazil	112014011745
Canada	2854717
Cyprus	1123130
Denmark	2780003
European Patent Office	2780003