Details for Patent: 9,283,214

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Which drugs does patent 9,283,214 protect, and when does it expire?

Patent 9,283,214 protects JORNAY PM and is included in one NDA.

This patent has forty-eight patent family members in seventeen countries.

Summary for Patent: 9,283,214

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.
Inventor(s):	David Lickrish, Feng Zhang
Assignee:	Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:	US14/704,836
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

US Patent 9,283,214: Methylphenidate Bead Formulation, Claim Scope, Orange Book Status and Generic Risk

US Patent 9,283,214 protects a delayed-onset, extended-duration methylphenidate formulation based on a single population of multilayer beads. The patent requires a methylphenidate-containing core, a sustained-release coating, and a pH-dependent delayed-release coating. Its principal commercial relevance is the formulation used for evening administration and next-day ADHD symptom control associated with JORNAY PM.

The broadest claim is narrower than a generic “extended-release methylphenidate” claim. A potentially infringing product must satisfy the structural coating limitations and the specified pharmacokinetic and clinical-performance limitations. The patent’s projected term runs into 2032, subject to any applicable patent-term adjustment or regulatory exclusivity.

What does US Patent 9,283,214 protect?

The patent protects a solid oral composition containing methylphenidate beads with two functional coating layers:

1. A drug-containing core.
2. A sustained-release layer surrounding the core.
3. A delayed-release layer surrounding the sustained-release layer.

The formulation must also produce a defined pharmacokinetic profile in fasted human subjects:

Required parameter	Claim 1 limitation
Initial lag period	At least 7 hours
Plasma methylphenidate during lag	Less than 5% of Cmax
AUC0-10	Less than approximately 7% of AUC0-48
Tmax	Between 12 and 19 hours
Clinical effect	Significant ADHD-related improvement for at least 12 continuous hours

The claim therefore combines composition, dosage-form architecture, pharmacokinetics and clinical performance. Each limitation is material to infringement.

The patent is directed to a chronotherapeutic methylphenidate product. The formulation is administered at night, remains largely inactive during the early post-dose period, and releases methylphenidate during the morning and daytime period. This differentiates the claimed product from conventional extended-release products taken in the morning.

How broad is independent claim 1?

Claim 1 is a combination claim with four principal claim boundaries.

Structural limitation: a single population of beads

The composition must contain “a single population of beads.” The claim does not require one bead. It requires a bead population having the specified core and coating architecture.

A product containing several distinct bead populations with materially different release profiles may argue that it does not satisfy the “single population” limitation. That defense would depend on the product’s actual manufacturing design and the patent’s prosecution history.

The claim also requires each bead to have:

• A methylphenidate-containing core;
• A sustained-release layer enclosing the core; and
• A delayed-release layer enclosing the sustained-release layer.

A formulation using matrix particles, osmotic tablets, drug-layered pellets without the required coating sequence, or a capsule containing multiple independently engineered bead populations would present a stronger non-infringement position, subject to equivalence analysis.

Sustained-release limitation

The inner coating must provide sustained release. Dependent claims identify water-insoluble and water-permeable polymers, including ethyl cellulose, and may include water-soluble polymers.

Claim 15 specifies a sustained-release layer comprising:

• Ethyl cellulose;
• Hydroxypropyl cellulose;
• Dibutyl sebacate; and
• A metal stearate.

Claim 16 narrows the metal stearate to magnesium stearate.

These claims are directed to a controlled-permeability coating. Ethyl cellulose provides the principal water-insoluble film, while hydroxypropyl cellulose and excipients influence permeability, film formation and release rate. Dibutyl sebacate functions as a plasticizer.

Delayed-release limitation

The outer coating must delay release until the dosage form reaches a suitable intestinal environment. Claim 7 requires a pH-dependent polymer or copolymer that is insoluble in aqueous medium below pH 5.5.

The patent identifies several possible enteric or pH-dependent materials, including:

• Methacrylic acid copolymers;
• Cellulose acetate phthalate;
• Hydroxypropyl methylcellulose phthalate;
• Polyvinyl acetate phthalate;
• Hydroxypropyl methylcellulose acetate succinate;
• Cellulose acetate trimellitate;
• Shellac; and
• Other acrylic or cellulose-based polymers.

Claim 11 specifically recites methacrylic acid copolymer Type B. Claim 12 adds mono- and diglycerides, dibutyl sebacate and polysorbate 80.

The outer coating is central to the delayed-onset profile. A formulation with an equivalent in vitro dissolution profile but a different coating mechanism could still avoid literal infringement if it does not use the claimed structural limitations. The doctrine of equivalents could remain relevant, particularly if the alternative polymer performs substantially the same delayed-release function in substantially the same way.

Pharmacokinetic limitation

The pharmacokinetic limitations make claim 1 materially narrower than a conventional formulation claim. A potentially infringing product must demonstrate the claimed profile in fasted human subjects.

The relevant requirements are:

• At least seven hours during which plasma methylphenidate remains below 5% of Cmax;
• AUC0-10 below approximately 7% of AUC0-48; and
• Tmax between 12 and 19 hours.

A generic applicant would normally evaluate these limitations through comparative pharmacokinetic studies, dissolution data and formulation characterization. A product could contain the same polymers and still dispute infringement if it does not meet the claimed pharmacokinetic thresholds.

What do the dependent claims add?

The dependent claims divide into five major protection groups.

What core materials are protected?

Claims 2 through 6 cover the drug-containing core:

Claim	Added limitation
2	Substantially spherical bead
3	Methylphenidate hydrochloride
4	Povidone, hydroxypropyl methylcellulose, lactose, sucrose or microcrystalline cellulose
5	Microcrystalline cellulose
6	Nonpareil bead coated with methylphenidate

These claims protect common multiparticulate manufacturing approaches, particularly drug layering onto nonpareil seeds and the use of microcrystalline cellulose as a core excipient.

What coating compositions are protected?

Claims 9 through 17 cover coating chemistry.

The sustained-release layer may contain a plasticizer, including:

• Dibutyl sebacate;
• Tributyl citrate;
• Acetyl tributyl citrate;
• Acetyl triethyl citrate;
• Mineral oil;
• Castor oil; or
• A fixed oil.

The claims also cover water-insoluble, water-permeable polymers combined with water-soluble polymers. The most commercially relevant narrower combination is the ethyl cellulose, hydroxypropyl cellulose, dibutyl sebacate and magnesium stearate formulation recited in claim 16.

What dosage form and strength are protected?

Claims 18 through 20 require the bead population to be contained in a water-soluble capsule. Claim 19 covers 1 mg to 150 mg of methylphenidate or a pharmaceutically acceptable salt. Claim 20 narrows the dose to 80 mg.

The dosage-form limitation matters because a product using a tablet, sachet, or non-capsule multiparticulate package could challenge claims 18 through 20 while remaining exposed to claim 1.

What clinical outcomes are protected?

Claims 21 through 29 recite ADHD efficacy endpoints, including:

• ADHD-RS-IV;
• BSFQ;
• CGI;
• CGI-P;
• PREMB;
• PERMP; and
• SKAMP.

Claims 22 through 25 focus on children or adolescents and PERMP performance. Claim 24 covers evening administration around 8:00 p.m. to 10:00 p.m. followed by improvement from approximately 7:00 a.m. through 9:00 p.m. the next day. Claim 25 requires at least a 50% improvement over placebo.

Claims 26 through 28 cover SKAMP performance over approximately 12 continuous hours. Claim 29 addresses measurable BSFQ improvement over placebo following evening administration.

These clinical limitations create potential proof issues. A patent owner may need to establish that the accused product provides the claimed clinical effect, although infringement theories may focus first on the structural and pharmacokinetic elements.

When does US Patent 9,283,214 expire?

US Patent 9,283,214 was issued on March 15, 2016. Its term is based on the underlying nonprovisional application and related priority chain. Public patent records associate the patent with an expiration date in June 2032, commonly reported as June 18, 2032, before any applicable patent-term adjustment.[1]

Event	Date
Earliest relevant priority period	June 2012
US application filing	June 2013
US publication	December 2014
Patent grant	March 15, 2016
Projected expiration	June 2032
FDA approval of JORNAY PM	2018

Patent expiration does not by itself establish the end of all exclusivity. Other patents, pediatric exclusivity, regulatory exclusivity or later-issued continuation patents may affect generic launch timing.

What is the Orange Book status of US Patent 9,283,214?

US Patent 9,283,214 has been associated with the FDA Orange Book patent listing for JORNAY PM, the methylphenidate hydrochloride extended-release capsule product approved under NDA 211369.[2][3]

The patent’s relevance to an ANDA applicant is its coverage of the marketed product’s delayed-release and extended-release bead architecture. An ANDA applicant seeking approval before patent expiry would generally need to address the listed patent through one of the statutory certification pathways.

The Orange Book distinction is important:

• A listed patent may create a Paragraph IV certification issue.
• A patent not listed in the Orange Book may still support a separate patent infringement action.
• Orange Book listing does not establish validity or enforceability.
• A listed patent may cover the formulation, an approved method of use, or both.

The FDA label identifies JORNAY PM as a methylphenidate hydrochloride extended-release capsule intended for evening dosing and next-day ADHD symptom management.[3]

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant could challenge the patent through a Paragraph IV certification asserting that the patent is invalid, unenforceable or not infringed. The most credible technical routes would involve one or more of the following:

1. A non-bead dosage form.
2. Multiple bead populations rather than a single population.
3. A different delayed-release mechanism.
4. A formulation that fails the claimed fasted-state pharmacokinetic thresholds.
5. A product with a Tmax outside the 12-to-19-hour range.
6. A product that does not demonstrate the claimed clinical performance.
7. A formulation using different coating materials and a substantially different release mechanism.

The claim’s combination of structural and pharmacokinetic limitations creates both strength and vulnerability. It is stronger against a product that closely copies the marketed bead system. It is more difficult to enforce against a technically differentiated delayed-release methylphenidate product.

A Paragraph IV notice could trigger Hatch-Waxman litigation and, if filed within the statutory period, a potential 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii). The exact effect depends on the timing of notice, litigation filing, patent listing and FDA decision-making.

How strong is the patent estate for JORNAY PM?

The principal strength of US 9,283,214 is its alignment with the commercial product’s differentiated feature: evening administration followed by delayed morning release and extended daytime effect.

Strengths

• The claim requires a distinctive three-part bead architecture.
• The delayed-onset profile is defined by quantitative pharmacokinetic thresholds.
• The claims cover both formulation composition and clinical performance.
• Dependent claims capture common implementation details, including nonpareil cores, methylphenidate hydrochloride and ethyl cellulose coatings.
• The patent reaches the commercial rationale for the product, not merely the active ingredient.

Vulnerabilities

• Many coating materials listed in the claims are established pharmaceutical excipients.
• Delayed-release and sustained-release multiparticulate systems were known before the patent’s priority date.
• The claim combines numerous functional limitations that may create enablement, written-description and indefiniteness disputes.
• “Significant improvement” may require careful interpretation in litigation.
• The patent may be vulnerable to an engineered-around product that uses a different release mechanism or misses the specified pharmacokinetic window.
• Clinical limitations can be difficult to prove against an ANDA product without access to equivalent patient-level data.

The strongest claim for commercial enforcement is likely claim 1 because it does not require a particular polymer or dose. The strongest narrower claims for formulation mapping are claims 15, 16 and 20, provided the accused product uses the recited excipients and 80 mg strength.

How does JORNAY PM compare with competing methylphenidate products?

Product	Manufacturer or sponsor	General release profile	Evening dosing	Main distinction from the patented formulation
JORNAY PM	Ironshore Pharmaceuticals	Delayed and extended release	Yes	Night dosing with next-day coverage
Concerta	Janssen	Extended release	Generally morning	Osmotic tablet technology
Ritalin LA	Novartis and authorized generic suppliers	Biphasic extended release	Generally morning	Immediate-release and delayed-release bead fractions
Metadate CD	Various suppliers	Biphasic bead release	Generally morning	Immediate and extended-release bead populations
Aptensio XR	Rhodes Pharmaceuticals	Extended release	Generally morning	Different multiparticulate release design
Quillivant XR	Tris Pharma	Extended release suspension	Generally morning	Liquid formulation
Dyanavel XR	Tris Pharma	Extended release suspension	Generally morning	Liquid and chewable delivery options

The patent does not cover methylphenidate as an active ingredient generally. It targets a specific delayed-onset, extended-duration delivery strategy. Competing products using osmotic tablets, liquid suspensions or different bead populations occupy separate formulation territory, although their own patents may create independent freedom-to-operate issues.

What manufacturing and intellectual-property barriers matter?

The manufacturing barrier is not the active pharmaceutical ingredient. Methylphenidate hydrochloride is a known compound with established commercial manufacturing routes. The more significant barriers are:

• Consistent drug layering onto spherical cores;
• Uniform sustained-release film thickness;
• Control of delayed-release coating weight gain;
• Reproducible dissolution across pH conditions;
• Prevention of dose dumping;
• Capsule filling with a consistent bead load;
• Maintenance of the claimed fasted-state lag period; and
• Scale-up of coating processes without changing Tmax or early AUC.

A competing manufacturer may avoid literal infringement through a different coating sequence, polymer system or dosage form. That approach can increase development risk because the new formulation must still deliver the required morning onset, daytime duration, food-effect profile and dose proportionality.

What litigation and settlement issues should be monitored?

The most important litigation indicators are:

• Paragraph IV notices involving JORNAY PM;
• District court complaints by the NDA holder or patent owner;
• ANDA filer identity and proposed launch date;
• Patent-term or pediatric-exclusivity calculations;
• Claim-construction decisions involving “single population of beads”;
• Expert testimony on fasted-state PK testing;
• Prior-art attacks against the delayed-release bead architecture; and
• Any settlement granting a licensed or contingent generic launch.

A settlement could permit an authorized or independent generic launch before June 2032. Without a publicly reported agreement, no specific early-entry date should be treated as established.

Key Takeaways

• US Patent 9,283,214 is a formulation patent directed to delayed-onset and extended-duration methylphenidate beads.
• Claim 1 requires a single population of multilayer beads with a methylphenidate core, sustained-release coating and pH-dependent delayed-release coating.
• The claimed product must meet quantitative fasted-state PK requirements, including at least a seven-hour lag and Tmax between 12 and 19 hours.
• Dependent claims protect spherical cores, nonpareil beads, methylphenidate hydrochloride, ethyl cellulose systems, methacrylic acid copolymers, capsule dosage forms and 80 mg strength.
• The patent is associated with JORNAY PM and has a projected expiration in June 2032.
• Generic risk is highest for products that copy the marketed bead architecture and release profile.
• An engineered-around product could target a different dosage form, multiple bead populations, alternative polymers or a PK profile outside the claimed ranges.
• The patent’s enforceability will depend on claim construction, prior art, prosecution history and proof of the pharmacokinetic and clinical limitations.

FAQs

Does US Patent 9,283,214 cover all extended-release methylphenidate products?

No. It covers a specific multilayer bead composition with delayed-release and sustained-release functions plus defined pharmacokinetic and clinical limitations. Osmotic tablets, liquid suspensions and other release systems may fall outside the claim scope.

Does an 80 mg methylphenidate product automatically infringe the patent?

No. Claim 20 requires 80 mg, but the product must also meet the incorporated limitations of claim 1, including the bead structure, coating sequence and pharmacokinetic profile.

Can a generic avoid the patent by using a different enteric polymer?

Potentially. A different polymer may avoid literal infringement of narrower claims, but claim 1 contains broader functional and structural limitations. The doctrine of equivalents and prosecution history would remain relevant.

Is JORNAY PM protected by regulatory exclusivity after patent expiration?

Patent expiry and FDA regulatory exclusivity are separate issues. The approval date, pediatric exclusivity, Orange Book listings and any later-issued patents must be evaluated independently.

What is the most important technical test for a competing product?

The critical tests are multiparticulate structure, pH-dependent release, fasted-state lag, early AUC, Tmax and duration of clinical effect. Dissolution alone may not resolve infringement because claim 1 includes human pharmacokinetic and clinical limitations.

References

1. United States Patent and Trademark Office. (2016). US Patent No. 9,283,214, Methylphenidate formulations.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2018). JORNAY PM prescribing information. Ironshore Pharmaceuticals.
4. United States Code. (2023). 21 U.S.C. § 355: New drugs.
5. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation guidance.

Drugs Protected by US Patent 9,283,214

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 9,283,214

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788
China	103608004