Details for Patent: 10,086,087

Which drugs does patent 10,086,087 protect, and when does it expire?

Patent 10,086,087 protects DYANAVEL XR and is included in one NDA.

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

Summary for Patent: 10,086,087

Title:	Modified release formulations containing drug-ion exchange resin complexes
Abstract:	A particulate, modified release barrier coated drug-cation exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. Methods of making and products containing this coated complex are described.
Inventor(s):	Ketan Mehta, Yu-Hsing Tu
Assignee:	PROVIDENT BANK
Application Number:	US15/619,637
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,086,087
Patent Claim Types: see list of patent claims	Compound;

US Patent 10,086,087: Claim Scope, Exclusivity, Litigation Risk, and Amphetamine Suspension Patent Landscape

US Patent 10,086,087 protects specific extended-release oral liquid suspensions containing amphetamine or dextroamphetamine bound to a water-insoluble cation-exchange resin. The core combination is a population of heavily barrier-coated drug-resin particles, uncoated immediate-release drug-resin particles, and an aqueous suspension vehicle. The independent claims require a narrowly defined formulation architecture, including particle size, coating weight, coating elasticity, plasticizer content, and, in claim 1, a polyvinyl acetate diffusion barrier.[1]

The patent is most relevant to Dyanavel XR-type amphetamine extended-release oral suspensions. It does not broadly cover every liquid amphetamine formulation, every ion-exchange-resin product, or every extended-release stimulant dosage form.

What drug product and technology does US Patent 10,086,087 protect?

The patent covers an orally ingestible aqueous suspension using ion-exchange-resin drug complexes to control amphetamine release.

The claimed formulation has two functional drug populations:

1. Modified-release particles consisting of amphetamine or dextroamphetamine bound to a water-insoluble cation-exchange resin and coated with a water-permeable diffusion barrier.
2. At least one uncoated amphetamine-resin or dextroamphetamine-resin particulate population.

The formulation may also contain free, non-resin-bound amphetamine or dextroamphetamine. This creates a release profile with an initial drug component and a prolonged-release component.

The patent claims a formulation rather than a treatment regimen, manufacturing process, patient population, or dosing schedule.

Core technical elements

Claim element	Required limitation
Dosage form	Orally ingestible aqueous liquid suspension
Active drug	Amphetamine or dextroamphetamine
Resin	Pharmaceutically acceptable, water-insoluble cation-exchange resin
Particle size	Capable of passing through a number 40 mesh screen
Modified-release coating	Water-permeable, water-insoluble, non-ionic diffusion barrier
Coating weight	About 20% to about 50% of barrier-coated particulate weight
Coating elasticity	Elongation factor of about 125% to about 400%
Plasticizer	About 2.5% to about 20% of coating weight
Independent claim 1 polymer	Polyvinyl acetate
Additional drug population	Uncoated dextroamphetamine-resin or amphetamine-resin particles
Suspension medium	Pharmaceutically acceptable aqueous base

The claimed architecture is designed to avoid reliance on an enteric coating. Release control comes from the diffusion barrier surrounding the drug-resin particles.

How do claims 1 through 11 differ from claims 12 through 22?

Claims 1 and 12 are separate independent claims with different points of technical emphasis.

Claim 1 family

Claim 1 requires:

• A barrier-coated drug-resin complex;
• A coating containing a water-insoluble polymer;
• Polyvinyl acetate as the water-insoluble polymer;
• A plasticizer;
• Uncoated resin-bound amphetamine or dextroamphetamine particles;
• An aqueous suspension base.

Claims 2 through 11 narrow claim 1 by adding:

• Cured coating;
• Specified plasticizers;
• Stabilizer;
• Higher coating levels of 30% to 50% or 30% to 45%;
• Uncoated dextroamphetamine-resin particles;
• Uncoated amphetamine-resin particles;
• Free amphetamine or dextroamphetamine;
• A sulfonated styrene-divinylbenzene resin;
• Plasticizer concentration of 5% to 10%.

Claim 12 family

Claim 12 differs because the drug-resin complex itself must further contain a polymer or copolymer, or a hydrophilic polymer, forming a matrix with the drug-resin complex.

This creates a two-level structure:

1. A drug-resin-polymer matrix; and
2. A modified-release diffusion coating around the matrix.

Claims 13 through 22 narrow this structure through:

• Polyvinylpyrrolidone as the hydrophilic matrix polymer;
• Coating levels of 30% to 50% or 30% to 45%;
• Uncoated dextroamphetamine-resin or amphetamine-resin particles;
• Free active drug;
• Sulfonated styrene-divinylbenzene resin;
• Listed plasticizers;
• Polyvinyl acetate in the diffusion coating;
• Cured coating.

Claim 12 may be broader than claim 1 with respect to the outer coating polymer because it does not expressly require polyvinyl acetate in the independent claim. Claim 21 adds that limitation to claim 12.

What is the likely scope of claim 1?

Claim 1 is a combination claim. An accused product must contain each required element, including the particular release architecture.

A product is more likely to fall within claim 1 if it has all of the following:

• An aqueous amphetamine suspension;
• Amphetamine or dextroamphetamine bound to a water-insoluble cation-exchange resin;
• Resin particles below approximately 420 micrometers, corresponding generally to a number 40 sieve;
• A polyvinyl acetate-containing outer barrier coating;
• Coating weight within the 20% to 50% range;
• Plasticizer within the 2.5% to 20% range;
• Coating elongation within the 125% to 400% range;
• A separate uncoated amphetamine-resin or dextroamphetamine-resin population.

The uncoated population is a major limitation. A formulation containing only coated particles may avoid literal infringement of claim 1 if it does not satisfy the independent claim's requirement for at least one uncoated resin-bound component.

The optional free-drug elements in claims 1 and 12 do not narrow the independent claims unless present. The claim requires at least one uncoated resin-bound component, but free amphetamine or dextroamphetamine is optional.

What formulation parameters create the greatest design-around opportunities?

The most important design-around variables are the outer polymer, particle population, coating percentage, and release-control mechanism.

Polymer substitution

Claim 1 expressly requires polyvinyl acetate. A formulation using ethylcellulose, cellulose acetate, ammonio methacrylate copolymers, polyethylene, or another water-insoluble polymer may avoid literal infringement of claim 1. It could still face claim 12 if the formulation uses the claimed internal polymer matrix and satisfies the remaining elements.

Removal of uncoated particles

A product using only modified-release coated particles may avoid claims requiring uncoated amphetamine-resin or dextroamphetamine-resin particles. The risk depends on whether uncoated particles are present as a manufacturing residual, separate release fraction, or measurable formulation component.

Alteration of coating weight

The 20% to 50% coating range is central to the independent claims. A coating below 20% or above 50% may provide a literal-claim design-around, although the terms "about" and potential equivalents analysis could expand the practical range.

Change in particle size

The number 40 mesh limitation provides another potential design-around. A formulation using larger particles may avoid the claim, but particle size must be assessed against the actual screening method, batch distribution, and whether a substantial portion of particles passes the specified mesh.

Change in release mechanism

A formulation using a chemically modified active ingredient, an osmotic system, a lipid matrix, a pH-dependent coating, or a non-resin polymer matrix would have a stronger non-infringement position if it does not contain the claimed drug-cation exchange resin complex.

What is the patent strength of US 10,086,087?

The patent has moderate-to-strong blocking value against close copies of the claimed formulation, but weaker coverage against alternative extended-release technologies.

Strengths

• The claims combine multiple formulation parameters, making a close commercial copy easier to identify.
• Polyvinyl acetate, resin binding, particle size, coating weight, plasticizer content, and uncoated drug-resin particles provide several independent infringement hooks.
• The claims cover both dextroamphetamine and amphetamine.
• The claims address an aqueous suspension, a dosage form with fewer conventional extended-release design options than tablets or capsules.
• Claim 12 adds an internal matrix limitation that can capture formulations using a polymer-containing drug-resin particulate.

Vulnerabilities

• The claims are technically dense and contain multiple quantitative limitations.
• Terms such as "about," "elongation factor," "water permeable," and "non-ionic" may generate claim-construction disputes.
• A competitor can potentially change one major structural variable while preserving an extended-release profile.
• The claim requires a specific combination of coated and uncoated particle populations.
• Patent validity could be challenged using earlier ion-exchange-resin stimulant formulations, polymer-coated resin particles, and prior art concerning aqueous sustained-release suspensions.

The patent's commercial strength is therefore highest against a Dyanavel XR-like formulation and lower against unrelated amphetamine delivery systems.

When does US Patent 10,086,087 lose exclusivity?

US Patent 10,086,087 issued on October 2, 2018.[1] Its patent term is generally governed by the 20-year term from the earliest effective nonprovisional U.S. filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.[2]

The patent family is associated with an early-2030s expiration horizon. The effective expiration date must be taken from the USPTO patent-term calculation and any Orange Book patent record applicable to the approved product. The issue date alone does not determine expiration.

The relevant exclusivity layers are:

Exclusivity layer	Relevance
Patent exclusivity	Expected to extend into the early 2030s, subject to the official term calculation
FDA new-drug exclusivity	Depends on the applicable NDA approval and exclusivity designation
Pediatric exclusivity	May add six months if granted for the relevant NDA
Orange Book listing	Determines whether an ANDA applicant must address the patent through certification
Regulatory exclusivity	Separate from patent enforceability and may expire earlier

A patent expiration date does not automatically authorize generic launch if other listed patents, regulatory exclusivities, or litigation restraints remain in force.

What is the Orange Book status and Paragraph IV risk?

The key regulatory question is whether US Patent 10,086,087 is listed in the FDA Orange Book for the relevant amphetamine extended-release suspension, most likely Dyanavel XR or a related approved product.[3]

If listed, an ANDA applicant seeking approval before patent expiration would typically need to submit one of the following certifications:

• Paragraph I: No patent information has been submitted;
• Paragraph II: The patent has expired;
• Paragraph III: The applicant will wait until patent expiration;
• Paragraph IV: The patent is invalid, unenforceable, or will not be infringed.

A Paragraph IV certification can trigger a patent-infringement action within 45 days of notice. A timely suit can impose a 30-month FDA approval stay under the Hatch-Waxman framework, subject to statutory exceptions and court rulings.[4]

For this patent, a Paragraph IV challenge would likely focus on:

1. Whether the proposed product contains the required coated and uncoated resin-bound particle populations;
2. Whether the coating is polyvinyl acetate;
3. Whether the coating weight falls within the claimed range;
4. Whether the coating has the claimed elongation factor;
5. Whether the drug-resin particles pass a number 40 mesh screen;
6. Whether prior art renders the formulation obvious.

An ANDA applicant could also pursue a product design that avoids one or more claim limitations and file a Paragraph III certification for patents it does not challenge.

Which products compete with the protected formulation?

The competitive landscape includes both liquid amphetamine products and non-liquid extended-release stimulants.

Product or platform	Active ingredient	Dosage form	Relationship to patent
Dyanavel XR	Amphetamine extended release	Oral suspension	Closest commercial technology
Adderall XR	Mixed amphetamine salts	Extended-release capsule	Different dosage form and release platform
Mydayis	Mixed amphetamine salts	Extended-release capsule	Different multiparticulate technology
Vyvanse	Lisdexamfetamine	Capsule and chewable	Prodrug, not resin-based
Adzenys ER	Amphetamine	Extended-release oral suspension	Potentially relevant competing liquid product
Evekeo	Amphetamine sulfate	Tablet	Immediate-release product
Xelstrym	Dextroamphetamine	Transdermal system	Non-oral delivery system

The closest competitive threat is another amphetamine oral suspension using a different release technology. Capsule and tablet products generally do not practice the claimed aqueous suspension limitations.

Is biosimilar risk relevant to this patent?

No. Biosimilar law does not apply because amphetamine and dextroamphetamine are small-molecule active ingredients, not biologic products regulated through the Biologics Price Competition and Innovation Act pathway.[5]

The relevant competitors are ANDA applicants and, potentially, 505(b)(2) applicants. A generic liquid suspension could seek approval through an ANDA if it can establish pharmaceutical equivalence and bioequivalence. A materially different formulation, delivery system, or clinical profile could require a 505(b)(2) application.

What litigation and settlement issues matter?

The patent text does not establish litigation, settlement, licensing, or covenant-not-to-sue terms. Those issues must be assessed through court dockets, FDA Paragraph IV records, SEC disclosures, and transaction announcements.

For commercial diligence, the material questions are:

• Whether the patent has been asserted against an ANDA applicant;
• Whether a 30-month stay was triggered;
• Whether a court entered a claim-construction or validity decision;
• Whether a settlement includes a licensed entry date;
• Whether the settlement contains restrictions on authorized generic supply;
• Whether another Tris-related patent remains a separate entry barrier.

A settlement can permit a generic launch before patent expiration while leaving the patent valid. The launch date, not the existence of a settlement alone, determines practical market erosion.

What manufacturing and IP barriers does the patent create?

The formulation requires process control over:

• Resin loading with amphetamine or dextroamphetamine;
• Particle-size classification;
• Polymer matrix formation for claim 12 embodiments;
• Application of a high-weight diffusion coating;
• Plasticizer incorporation;
• Coating curing;
• Measurement of elongation and release performance;
• Uniform suspension of coated and uncoated particle populations.

These requirements create manufacturing barriers even where a competitor avoids literal infringement. Reproducing the release profile may require similar coating equipment, curing conditions, resin chemistry, and particle-size controls.

The highest-risk technical area is the coating. A 20% to 50% coating level is substantial, and the claimed elongation range indicates that coating flexibility is important to prevent cracking during processing, storage, and suspension handling.

How does this patent compare with broader amphetamine patent protection?

US Patent 10,086,087 is narrower than a patent claiming amphetamine generally, but potentially more commercially relevant for an aqueous extended-release suspension.

Patent type	Scope	Competitive impact
Active-ingredient patent	Amphetamine or dextroamphetamine molecule	Usually unavailable for older active ingredients
Salt or crystal patent	Specific salt, polymorph, or solid form	Relevant to tablets and capsules
Method-of-use patent	ADHD, narcolepsy, or dosing regimen	Can affect product labeling and ANDA carve-outs
Formulation patent	Resin complex, polymer coating, aqueous suspension	Directly relevant to Dyanavel XR-type products
Manufacturing patent	Coating, curing, resin loading, or particle classification	Can block production processes
Device or packaging patent	Metering, dosing, or suspension delivery	May create secondary barriers

This patent is principally a formulation and composition patent. It does not independently create broad exclusivity over amphetamine therapy.

Key Takeaways

• US Patent 10,086,087 targets a specific extended-release amphetamine aqueous suspension.
• The central formulation requires coated drug-resin particles plus at least one uncoated drug-resin population.
• Claim 1 expressly requires polyvinyl acetate in the diffusion barrier.
• Claim 12 covers a related structure with a polymer-containing drug-resin matrix.
• The principal quantitative limitations are 20% to 50% coating weight, 2.5% to 20% plasticizer, 125% to 400% elongation, and number 40 mesh particle size.
• The patent is strongest against close Dyanavel XR-type copies and weaker against capsules, tablets, prodrugs, transdermal systems, and non-resin liquid formulations.
• Generic exposure would proceed through the ANDA and Paragraph IV framework, not biosimilar litigation.
• The patent has an early-2030s expiration horizon, subject to official patent-term adjustment and any applicable regulatory extensions.
• Product-specific Orange Book listings and later-issued family patents must be reviewed together before determining a launch date.

Frequently Asked Questions

Does US Patent 10,086,087 cover all Dyanavel XR formulations?

It may cover formulations that satisfy the claimed resin, coating, particle-size, plasticizer, and mixed coated/uncoated particle limitations. Coverage depends on the approved product's actual composition and the patent listing applicable to that product.

Can a generic avoid this patent by using ethylcellulose instead of polyvinyl acetate?

Potentially. Substituting ethylcellulose may avoid the express polyvinyl acetate limitation in claim 1, but claim 12 and other related patents must be analyzed separately.

Is free amphetamine required for infringement?

No. Free amphetamine or dextroamphetamine is optional under claims 1 and 12. The required additional drug population is an uncoated amphetamine-resin or dextroamphetamine-resin particulate population.

Does the patent cover a tablet containing amphetamine resin particles?

Not under the claims provided. Each independent claim requires an orally ingestible aqueous liquid suspension.

What is the most important prior-art risk?

The principal prior-art risk concerns combinations of ion-exchange-resin drug complexes, polymer-coated sustained-release particles, plasticized water-insoluble coatings, and aqueous suspensions. Obviousness analysis would likely focus on whether a skilled formulator would have combined those teachings for amphetamine or dextroamphetamine.

Can a 505(b)(2) applicant avoid the patent?

A 505(b)(2) applicant may avoid particular claims through a materially different formulation, but the application pathway does not eliminate patent infringement risk. Any formulation practicing the claimed structure can remain subject to enforcement.

References

1. U.S. Patent No. 10,086,087. (2018). Orally ingestible aqueous liquid suspension comprising modified-release amphetamine or dextroamphetamine ion-exchange-resin particulates. United States Patent and Trademark Office.

2. United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation. https://www.uspto.gov

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.accessdata.fda.gov

4. Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).

5. Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. § 262.

Drugs Protected by US Patent 10,086,087

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes			Y

International Family Members for US Patent 10,086,087

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E536867
Australia	2007227569
Brazil	PI0709606
Canada	2645855