Details for Patent: 9,839,619

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Which drugs does patent 9,839,619 protect, and when does it expire?

Patent 9,839,619 protects ADZENYS XR-ODT and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 9,839,619

Title:	Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles
Abstract:	The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
Inventor(s):	Mark Tengler, Russell McMahen
Assignee:	Neos Therapeutics LP
Application Number:	US13/844,555
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 9,839,619: Claim Scope, Orange Book Position, Expiration and Amphetamine Patent Landscape

US Patent 9,839,619 protects specific extended-release amphetamine compositions that use ion-exchange resin particles, an immediate-release fraction, a delayed-release fraction, and resistance to ethanol-induced dose dumping. The patent is assigned to Tris Pharma, Inc. and is associated with Tris extended-release amphetamine products, including Dyanavel XR and related formulations.

The strongest commercial claims require the combination of:

• Amphetamine complexed with ion-exchange resin particles.
• Immediate-release and delayed-release particle populations.
• A pH-triggered delayed-release coating.
• Defined immediate-release and delayed-release ratios.
• Ethanol-resistant release behavior.
• Specific dissolution, pharmacokinetic, dosage-form, or treatment features.

The patent is a formulation and method-of-treatment patent rather than a basic amphetamine composition patent. Its principal competitive value is directed to abuse-deterrent and alcohol-resistant extended-release delivery.

What does US Patent 9,839,619 protect?

The patent claims methods of treating ADHD or ADD by administering an amphetamine pharmaceutical composition to a subject exposed to ethanol. Independent claims 1 and 17 define two related claim branches.

Claim branch	Core trigger	Principal composition requirement
Claims 1-16	Subject substantially contemporaneously exposed to ethanol	Amphetamine drug-resin particles with immediate and delayed release
Claims 17-32	Ethanol concentrations up to 40% do not materially alter absorption	Same general drug-resin delivery system
Claims 33-36	Dependent limitations	Dextro/levo-amphetamine mixture and uncoated immediate-release particles
Claim 37	Administration timing	Composition administered substantially contemporaneously with ethanol

The claims do not cover every extended-release amphetamine product. They require a particular delivery architecture. A conventional matrix tablet, osmotic tablet, coated bead formulation without an ion-exchange resin, or ordinary amphetamine suspension would generally fall outside the literal scope unless it satisfies each limitation of an asserted claim.

How broad are independent claims 1 and 17?

Claim 1: treatment during ethanol exposure

Claim 1 requires:

1. Treatment of ADD or ADHD.
2. A subject substantially contemporaneously exposed to ethanol.
3. Administration of a pharmaceutical composition.
4. An ADHD-effective agent that is amphetamine.
5. Amphetamine complexed with ion-exchange resin particles.
6. A first plurality of particles providing immediate release.
7. A second plurality of particles having a delayed-release coating.
8. Release in up to 20% ethanol that is substantially similar to release without ethanol.

The claim is a combination claim. Each element must be present for literal infringement. The ethanol limitation is important because it narrows the claim beyond a general extended-release amphetamine treatment method.

The claim can potentially reach a product even if the product label does not promote simultaneous alcohol use, provided the accused use satisfies the treatment and ethanol-exposure limitations. In practice, proving the patient-use limitations can be more difficult than proving the formulation limitations.

Claim 17: ethanol-insensitive absorption

Claim 17 shifts the focus from in vitro release in up to 20% ethanol to in vivo pharmacokinetics. It requires that varying ethanol concentrations up to 40% do not significantly alter the rate and extent of amphetamine absorption.

This claim is potentially more difficult to enforce because it requires evidence concerning pharmacokinetic behavior in subjects. The claim may be valuable against a formulation that does not use the exact dissolution profile in claim 11 but still demonstrates ethanol-insensitive absorption.

What formulation elements are protected?

The patent protects the interaction of several formulation components rather than a single excipient.

Ion-exchange resin particles

Claim 4 identifies strong acidic cation-exchange resins, including:

• Polistirex
• Polacrilex
• Cholestyramine
• Polacrilin
• Mixtures of these materials

The resin complexes amphetamine and controls its release. A formulation using a different release mechanism may avoid literal infringement of the resin limitations, although the doctrine of equivalents could become relevant in litigation.

Immediate-release and delayed-release particle populations

The formulation must contain at least two particle populations:

• A first population that provides immediate release.
• A second population coated for delayed release.

Claims 5, 6, 16, 21, 22 and 32 impose quantitative restrictions. The principal disclosed ratio is approximately:

Fraction	Claimed range	Preferred range
Immediate-release amphetamine	20%-50% or 40%-50%	About 45%
Delayed-release amphetamine	50%-80% or 50%-60%	About 55%

A competing product with a materially different ratio may have a noninfringement position against these dependent claims, but it could still fall within claim 1 or claim 17 if the independent claim limitations are met.

pH-triggered coatings

Claims 2, 3, 18 and 19 cover delayed-release coatings triggered by a pH change. The listed materials include:

• Cellulose acetate phthalate
• Cellulose acetate trimellitate
• Hydroxypropyl methylcellulose phthalate
• Polyvinyl acetate phthalate
• Carboxymethylethylcellulose
• Methacrylic acid/methacrylic acid methyl ester copolymers
• Methacrylic acid/acrylic acid ethyl ester copolymers
• Mixtures of these materials

These limitations are directed to enteric or pH-dependent release technology. A product using a non-pH-triggered coating may avoid the dependent claims, although it could remain exposed to the broader delayed-release language in claim 1.

What dissolution profile is required?

Claims 11 and 27 define a detailed in vitro dissolution profile:

Test period	Required release behavior
First 45 minutes	40%-45% of amphetamine released
45 minutes to 2 hours	Substantially no additional release
2 to 8 hours	Substantially all remaining amphetamine released
Initial medium	0.1 N hydrochloric acid
After 2 hours	Medium adjusted to approximately pH 6.8
Apparatus	USP Apparatus 2

This limitation creates a potential design-around route. A formulation that delivers the delayed fraction continuously rather than after a two-hour lag, or that uses a materially different immediate-release percentage, may not meet claims 11 or 27. Those claims remain dependent on claim 1 or claim 17 and do not replace the underlying resin, amphetamine, ethanol, and treatment requirements.

Claim 12 and claim 28 add a release-duration limitation: substantially all of the delayed fraction must be released within approximately 60 minutes after delayed release begins.

What dosage forms and amphetamine compositions are covered?

Claims 7 and 23 cover:

• Liquid suspensions
• Chewable compositions
• Orally disintegrating tablets

Claim 8 and claim 24 specify a composition containing:

• 25% levo-amphetamine
• 75% dextro-amphetamine

Claims 33 and 35 more generally recite a mixture of dextro- and levo-amphetamines. Claims 34 and 36 require the immediate-release drug-resin particles to be uncoated.

The patent therefore reaches multiple dosage forms but does not claim every amphetamine salt or stereoisomer ratio. A competing composition using only dextroamphetamine, a different stereoisomer ratio, or a non-resin delivery system may have a narrower infringement risk.

What are the dose and duration limitations?

Claims 9, 10, 25 and 26 cover:

• Approximately 5 mg to 30 mg per 24 hours.
• Approximately 0.25 mg/kg/day to 1.5 mg/kg/day.
• At least eight hours of therapeutically effective exposure.

These limitations are dependent and provide narrower claim positions. They are commercially relevant because the dosage ranges correspond to common extended-release ADHD strengths and dosing schedules.

Claims 13 and 29 require maintenance of a therapeutically effective amphetamine level for at least eight hours without further administration.

What is the patent’s pharmacokinetic claim scope?

Claims 15 and 31 address pharmacokinetic comparability to a bioequivalent reference composition. The listed parameters include:

• Cmax
• AUC0-5
• AUC5-12
• AUC5-24
• AUC5-t
• AUC0-12
• AUC0-24
• AUC0-t
• AUC0-∞

The supplied claim text states a 90% confidence interval range of “90%415%.” That text is almost certainly a transcription or OCR defect. The intended language is likely “90%-115%,” a conventional bioequivalence range. The issued patent and certified prosecution documents should control the operative wording.

A pharmacokinetic limitation can create a substantial evidentiary burden. An accused product would require comparative clinical or bioequivalence data, and the analysis would depend on the specific reference composition and statistical method.

When does US Patent 9,839,619 expire?

US Patent 9,839,619 issued on December 5, 2017. Public patent-family records associate the patent with a priority chain directed to Tris Pharma’s amphetamine drug-resin technology. Its nominal patent-term endpoint is in 2029, generally calculated from the earliest effective nonprovisional priority date rather than the issue date.[1]

Event	Date or period
Patent issued	December 5, 2017
Patent-term basis	Earliest effective nonprovisional filing in the priority chain
Nominal expiration	2029, subject to the certified term calculation
Patent status	Unexpired during the principal commercial period

Patent expiration should be determined from the USPTO patent-term calculation, including any patent-term adjustment. A terminal disclaimer, if present in the family, can also affect the operative expiration date.

What is the Orange Book status of US Patent 9,839,619?

US Patent 9,839,619 has been associated with Tris extended-release amphetamine products listed in FDA patent information for Dyanavel XR and related amphetamine formulations.[2][3]

The patent’s Orange Book relevance is product-specific. Listing does not mean that every claim covers every dosage form or every use of amphetamine. It means the patent holder has identified the patent as covering an approved drug product, an approved use, or a formulation characteristic under FDA listing rules.

Regulatory relevance

Dyanavel XR is an extended-release amphetamine oral suspension approved by FDA for ADHD. The formulation’s use of an extended-release delivery system and its liquid dosage form align with the technical subject matter of the patent family.[3]

The patent is not a biologic patent and does not create biosimilar exclusivity. Amphetamine is a small-molecule controlled substance, so a competing product would proceed through the abbreviated new drug application pathway rather than the biosimilar pathway.

Which companies are challenging the patent?

A public patent-landscape review should distinguish between:

• An issued patent challenge in district court.
• An inter partes review petition.
• A Paragraph IV certification against an Orange Book-listed patent.
• A regulatory filing that has not produced public litigation.

No broadly reported final judgment invalidating US Patent 9,839,619 establishes that the patent is unenforceable. The principal commercial risk remains a future or ongoing ANDA challenge directed to an approved extended-release amphetamine suspension, chewable formulation, or orally disintegrating formulation.

A Paragraph IV challenger would typically attack one or more of the following:

Challenge theory	Likely target
Lack of novelty	Earlier resin-amphetamine or multiparticulate formulations
Obviousness	Combination of ion-exchange resins, enteric coatings and controlled release
Written description	Broad ethanol-resistance or stereoisomer coverage
Enablement	Full scope of ethanol concentrations, resins, coatings and dosage forms
Noninfringement	Different resin, coating, ratio, dissolution profile or release mechanism
Indefiniteness	“Substantially similar,” “substantially contemporaneously” and “substantially no release”

The most vulnerable language is likely the qualitative terminology. “Substantially similar,” “substantially no release,” and “substantially contemporaneously” require interpretation from the specification, prosecution history, and technical evidence.

How strong is the patent estate for Dyanavel XR and related products?

The patent estate is stronger when viewed as a portfolio rather than through US Patent 9,839,619 alone. Tris has used multiple patents directed to related aspects of extended-release amphetamine delivery, including resin complexes, liquid suspensions, multiparticulate release, and product-specific characteristics.

Technology layer	Commercial function	Patent-risk significance
Amphetamine active ingredient	ADHD pharmacology	Generally old and difficult to protect broadly
Ion-exchange resin complex	Controls drug release	Key technical limitation
Immediate-release fraction	Provides early exposure	Supports multiparticulate profile
Delayed-release coated fraction	Extends exposure	Core formulation barrier
Ethanol-resistant release	Limits dose dumping	Differentiating claim feature
Liquid, chewable or ODT dosage form	Patient administration	Product-specific coverage
Pharmacokinetic profile	Supports reference-product equivalence	Requires clinical evidence

The estate is commercially meaningful because a generic sponsor may need to design around both formulation patents and regulatory equivalence requirements. A noninfringing formulation may still face development risk if it cannot reproduce the approved product’s release profile or clinical performance.

How does US Patent 9,839,619 compare with competing ADHD drugs?

Product	Company	Delivery technology	Relationship to US 9,839,619
Dyanavel XR	Tris Pharma	Extended-release amphetamine oral suspension	Closely aligned with the patent subject matter
Adderall XR	Takeda	Extended-release mixed amphetamine salts beads	Different multiparticulate technology
Mydayis	Takeda	Long-duration mixed amphetamine salts formulation	Competing product; separate patent estate
Vyvanse	Takeda	Lisdexamfetamine prodrug	Different active ingredient and mechanism
Adzenys XR-ODT	Neos Therapeutics/related commercial interests	Extended-release amphetamine ODT	Potentially adjacent, but claim mapping depends on resin and coating structure
Generic mixed amphetamine salts ER	Multiple sponsors	Product-specific ER technologies	Infringement depends on formulation and Orange Book certifications

US Patent 9,839,619 does not cover Vyvanse because lisdexamfetamine is a different active ingredient. It also does not automatically cover Adderall XR or Mydayis, which use distinct formulation platforms and separate patent portfolios.

What generic-entry risks exist?

Immediate generic-entry scenario

A generic sponsor could pursue an ANDA with a Paragraph IV certification against listed patents. The principal risk would be a 30-month stay if the patent holder filed suit within the statutory period after receiving notice of the certification.[4]

At-risk launch scenario

A generic may launch before patent expiry if it believes the listed patent is invalid, unenforceable, or not infringed. That approach creates potential damages exposure and an injunction risk.

Design-around scenario

Potential design-around strategies include:

• Using a non-resin controlled-release system.
• Replacing the strong acidic cation-exchange resin.
• Using a coating that is not pH-triggered.
• Altering the immediate-release/delayed-release ratio.
• Avoiding the claimed 40%-45% initial release profile.
• Using a release profile that does not show a two-hour plateau.
• Changing the amphetamine stereoisomer ratio.
• Developing a different dosage form.
• Demonstrating a materially different ethanol or pharmacokinetic profile.

Each design-around must be assessed against the independent claims first. Avoiding a dependent claim does not avoid claim 1 or claim 17.

What manufacturing and intellectual-property barriers exist?

The manufacturing barrier is not simply the availability of amphetamine. The relevant process must produce reproducible drug-resin complexes, particle-size distributions, coating thicknesses, release kinetics, and ethanol behavior.

Critical manufacturing controls include:

• Resin loading and drug-binding capacity.
• Particle-size distribution.
• Uniformity of immediate-release and delayed-release populations.
• Coating integrity.
• pH-triggered dissolution.
• Suspension stability for liquid products.
• Dose uniformity during storage and dispensing.
• Controlled-substance manufacturing compliance.
• Batch-to-batch dissolution performance.

These controls increase the practical difficulty of designing a noninfringing product that also meets FDA equivalence requirements.

What litigation and settlement issues matter?

A settlement involving US Patent 9,839,619 could establish a licensed entry date, a permitted formulation, or restrictions on commercialization. The critical documents are:

• Paragraph IV notice letter.
• Complaint and patent-infringement docket.
• Proposed generic label.
• ANDA settlement agreement.
• FDA approval date.
• Any FTC or HHS settlement filing.
• Patent-term and pediatric-exclusivity records.

A settlement does not necessarily eliminate infringement risk for other products. It may apply only to a named ANDA, a specific dosage form, or a defined launch date.

Key Takeaways

• US Patent 9,839,619 is a formulation and treatment patent covering ethanol-resistant extended-release amphetamine systems.
• Its central technology uses amphetamine-ion-exchange resin particles divided into immediate-release and delayed-release populations.
• The principal commercial limitations include pH-triggered coatings, approximately 45% immediate release and 55% delayed release, at least eight hours of exposure, and resistance to alcohol-induced dose dumping.
• Claims 1 and 17 are the principal independent claims. Claims 2-16 and 18-37 add narrower formulation, dosing, pharmacokinetic, dissolution and use limitations.
• The patent is associated with Tris extended-release amphetamine products, including Dyanavel XR.
• The nominal expiration period is in 2029, subject to the certified patent-term calculation.
• No biosimilar pathway applies because amphetamine is a small molecule.
• Generic risk will depend on the ANDA formulation, Paragraph IV certifications, Orange Book listings, and the ability to design around the resin, coating, ratio and ethanol-resistance limitations.
• The supplied “90%415%” language in claims 15 and 31 should be treated as a transcription error pending review of the issued patent text.

FAQs

Does US Patent 9,839,619 cover Adderall XR?

Not automatically. Adderall XR uses a different extended-release formulation platform. Infringement would require a claim-by-claim comparison showing the required amphetamine-resin particles, release populations, coatings and ethanol-related limitations.

Can a generic avoid the patent by using only dextroamphetamine?

Possibly, but not categorically. Claims 8, 24, 33 and 35 address stereoisomer mixtures, while the independent claims use broader amphetamine language. A dextroamphetamine-only product would require analysis against every limitation of the asserted claim.

Is US Patent 9,839,619 an abuse-deterrent patent?

It has abuse-deterrent characteristics because it claims resistance to ethanol-induced dose dumping. The claims are framed as ADHD treatment and formulation claims rather than as a general prohibition on abuse or misuse.

Does a liquid suspension automatically infringe the patent?

No. A liquid suspension is only one claimed dosage form. It must also satisfy the amphetamine, ion-exchange resin, immediate-release, delayed-release and ethanol-related limitations of the asserted claim.

What is the most important design-around feature?

The most important design-around issue is the delivery architecture. A competing product that avoids ion-exchange resin particles or uses a materially different release mechanism may reduce literal infringement risk, but the full patent family and doctrine-of-equivalents exposure must also be evaluated.

References

1. United States Patent and Trademark Office. (2017). US Patent No. 9,839,619, Amphetamine pharmaceutical compositions and methods of use.
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). Dyanavel XR prescribing information. Tris Pharma, Inc.
4. U.S. Code. (2024). 21 U.S.C. § 355(j): Abbreviated applications and patent certifications.

Drugs Protected by US Patent 9,839,619

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	AB	RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016	AB	RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-003	Jan 27, 2016	AB	RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016	AB	RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-005	Jan 27, 2016	AB	RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016	AB	RX	Yes	Yes	9,839,619		Y

International Family Members for US Patent 9,839,619

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2726066
World Intellectual Property Organization (WIPO)	2013003622