Details for Patent: 11,166,947

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Which drugs does patent 11,166,947 protect, and when does it expire?

Patent 11,166,947 protects COTEMPLA XR-ODT and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 11,166,947

Title:	Effective dosing of a child for the treatment of ADHD with methylphenidate
Abstract:	The present invention generally relates to treating attention-deficit disorders (e.g., ADHD) by providing an effective amount of an ADHD-effective agent to a patient in need thereof (e.g., a child).
Inventor(s):	Mark Tengler, Nathan TEUSCHER
Assignee:	Neos Therapeutics LP
Application Number:	US16/346,850
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 11,166,947: Claim Scope, Methylphenidate Formulation Coverage, and Generic Entry Risk

U.S. Patent No. 11,166,947 is a Tris Pharma patent directed to patient-specific dosing of an extended-release racemic methylphenidate formulation. Its claims combine three protected elements: a multipart methylphenidate-ion exchange resin dosage form, a defined in vitro dissolution profile, and weight-based dosing of 10 mg to 60 mg methylphenidate hydrochloride equivalent. The patent is most relevant to Tris extended-release methylphenidate products, including QuilliChew ER and related formulations.

The patent’s strongest commercial coverage is created by the combination of formulation, dissolution, pharmacokinetic, and dosing limitations. A competing product must satisfy every material limitation of an asserted method claim to create literal infringement.

What does U.S. Patent 11,166,947 protect?

The patent protects methods of treating ADHD using an oral methylphenidate dosage form that has a specific controlled-release architecture and a weight-based dosing schedule.

The core limitations are:

Claim element	Required feature
Active ingredient	Racemic methylphenidate, including methylphenidate hydrochloride equivalent
Sustained-release component	Water-insoluble, water-permeable, pH-independent barrier-coated methylphenidate-ion exchange resin complex in a polymeric matrix
Immediate-release component 1	Uncoated methylphenidate-ion exchange resin complex
Immediate-release component 2	Uncomplexed racemic methylphenidate
Dissolution medium	Initial 0.1 N hydrochloric acid, adjusted to approximately pH 6.8 after two hours
Apparatus	USP Apparatus 2
Initial release	30% to 33% within 30 minutes
Two-hour release	34% to 42%
Four-hour release	40% to 80%
Twenty-four-hour release	80% to 100%
Pharmacokinetics	At least one specified PK parameter has a 90% confidence interval within 80% to 125% of a bioequivalent reference composition
Dosing	10 mg to 60 mg based on patient body-weight ranges
Indication	ADHD treatment

The patent does not claim methylphenidate generally. It claims a specific method that requires use of a formulation with a defined release profile and a defined composition.

How does claim 1 operate?

Claim 1 is a treatment-method claim with a product-by-process-style formulation definition.

The accused method must include:

1. Administration to an individual patient.
2. A therapeutically effective amount.
3. An oral dosage form containing an ADHD-effective agent.
4. The specified dissolution profile.
5. The specified USP Apparatus 2 testing conditions.
6. At least one qualifying pharmacokinetic relationship to a bioequivalent reference composition.
7. The three-part methylphenidate formulation.
8. The weight-correlated dosing table.

What formulation structure is required?

The sustained-release portion must contain a racemic methylphenidate-ion exchange resin complex in a polymeric matrix. That complex must be covered by a barrier coating that is:

• water-insoluble;
• water-permeable; and
• pH-independent.

The claim also requires two separate immediate-release sources:

• an uncoated methylphenidate-ion exchange resin complex; and
• uncomplexed racemic methylphenidate.

This structure is narrower than a generic extended-release methylphenidate formulation. A formulation based solely on a coated drug particle, a multilayer tablet, an osmotic system, or a single ion-exchange resin population may avoid literal infringement if it does not contain all three claimed components.

The claim does not appear limited to one particular polymer, resin, tablet shape, capsule, chewable dosage form, or inactive ingredient. The formulation language therefore leaves room for multiple dosage-form presentations, provided the required resin-complex and immediate-release architecture is present.

What dissolution profile does Patent 11,166,947 require?

The claimed profile is cumulative release, not a series of independent release fractions.

Testing point	Claimed cumulative release
30 minutes	30% to 33%
2 hours	34% to 42%
4 hours	40% to 80%
24 hours	80% to 100%

The assay begins in 0.1 N hydrochloric acid. After two hours, the medium is adjusted to approximately pH 6.8. Testing uses USP Apparatus 2.

The narrowest practical limitation is the 30-minute range of 30% to 33%. A formulation releasing less than 30% or more than 33% at that point would fall outside the literal scope of that limitation. The four-hour limitation is materially broader, allowing release anywhere from 40% to 80%.

The pH transition matters. Dissolution testing performed only at neutral pH, only in acid, or with a different apparatus may not reproduce the claimed assay. In litigation, testing protocol, vessel conditions, paddle speed, sampling, assay method, and treatment of dose-form disintegration would likely become material evidence.

What pharmacokinetic limitation applies?

Claim 1 requires that at least one listed PK parameter have a 90% confidence interval with both bounds inside 80% to 125% of the corresponding value for a bioequivalent reference composition.

The listed parameters include:

• Cmax;
• AUC0-5;
• AUC5-12;
• AUC5-24;
• AUC5-1;
• AUC0-12;
• AUC0-24;
• AUC0-t; and
• AUC0-∞.

The phrase “at least one” is important. The claim does not require every listed PK parameter to satisfy the 80% to 125% interval. Proof of one qualifying parameter may be enough for this element, assuming the other limitations are met.

The PK limitation also creates potential proof issues. The claim refers to a “bioequivalent reference composition,” but the identity of the reference composition, study design, fed or fasted state, dose normalization, population, sampling schedule, and statistical model can affect the analysis. An accused product could contest whether the comparison composition is the proper reference or whether the cited confidence interval was generated under comparable conditions.

What dosing schedule does claim 1 cover?

The claim links the methylphenidate hydrochloride equivalent to the patient’s body weight:

Body weight	Dose
Less than 12 kg, or 26 lb	10 mg
12 kg to less than 33 kg, or 26 lb to less than 73 lb	20 mg
33 kg to less than 55 kg, or 73 lb to less than 121 lb	30 mg
55 kg to less than 77 kg, or 121 lb to less than 169 lb	40 mg
77 kg to less than 99 kg, or 169 lb to less than 218 lb	50 mg
More than 99 kg, or more than 218 lb	60 mg

The boundaries create a drafting issue. The table uses overlapping or incompletely specified endpoints in places such as 33 kg, 55 kg, 77 kg, and 99 kg. A court could construe the ranges using the corresponding pound values, the intended sequential ranges, or the specification’s broader disclosure. The boundary language should be reviewed against the patent specification, prosecution history, and any terminal disclaimer or certificate of correction.

What does claim 2 add?

Claim 2 is a physician-assistance and prescribing method. It requires:

1. Determining the patient’s weight.
2. Referring to a chart or reference tool.
3. Identifying one dose corresponding to the patient’s weight range.
4. Administering the identified dose.

The chart must include the same 10 mg to 60 mg weight-based correlations.

Claim 2 is narrower in subject matter but potentially broader in practical actors because it addresses the prescribing workflow. It may implicate physicians, healthcare systems, electronic prescribing software, patient-support programs, and product labeling.

The claim requires use of the oral dosage form of claim 1. Therefore, claim 2 inherits the formulation, dissolution, PK, and composition limitations of claim 1. A dosing chart using the same weight ranges but paired with a materially different formulation would not necessarily satisfy claim 2.

When does U.S. Patent 11,166,947 expire?

The patent belongs to an older Tris methylphenidate patent family with priority claims dating to the late 2000s. The expected base patent-term endpoint is in 2027, subject to the controlling earliest effective nonprovisional or PCT filing date, patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

A practical expiration analysis should use the USPTO Patent Center term calculation rather than the issue date. The issue date, November 9, 2021, does not establish a new 20-year term. A continuation patent generally inherits the earlier family term and cannot reset expiration to 2041 merely because it issued in 2021. [1]

What related patents cover the Tris methylphenidate platform?

The relevant estate includes a series of U.S. patents directed to methylphenidate resin complexes, controlled-release formulations, dissolution characteristics, and related dosage forms. The following patents are commonly associated with the Tris methylphenidate platform and should be analyzed together rather than in isolation:

Patent	General subject matter	Strategic relevance
U.S. 8,778,390	Methylphenidate formulation technology	Foundational formulation coverage
U.S. 9,011,905	Methylphenidate dosage-form architecture	Resin-complex and release protection
U.S. 9,192,644	Extended-release methylphenidate formulations	Additional formulation coverage
U.S. 9,687,454	Methylphenidate release and dosage forms	Layered estate protection
U.S. 10,292,922	Methylphenidate formulation and treatment claims	Later continuation protection
U.S. 11,166,947	Weight-based treatment and prescribing methods	Patient-specific dosing and PK-linked coverage

The patents may have overlapping specifications, common inventorship, continuation relationships, or terminal disclaimers. Their enforceability cannot be determined from claim text alone. Prosecution history is material because narrowing amendments, examiner interviews, and arguments concerning dissolution or bioequivalence may limit claim construction.

What is the Orange Book status of Patent 11,166,947?

Orange Book listing depends on the specific approved product and NDA. A patent may be relevant to a product without being listed for every methylphenidate product.

For an approved product such as QuilliChew ER, the relevant questions are:

• whether Patent 11,166,947 is listed against the NDA;
• whether the listed claims are formulation, composition, or method-of-use claims;
• whether an unexpired claim corresponds to the approved labeling;
• whether the FDA has assigned a use code;
• whether the listed patent covers the dosage form actually marketed.

FDA-approved product labels and the FDA Orange Book remain the controlling sources for approved indications, dosage strengths, patent listings, and exclusivity data. [2][3]

A method-of-use patent can create a Paragraph IV issue if it is listed against an NDA and the generic applicant files a certification alleging that the patent is invalid, unenforceable, or not infringed. A product-by-product Orange Book review is required because patent listings can differ between Quillivant XR, QuilliChew ER, and other methylphenidate products.

What Paragraph IV and generic entry risks exist?

A generic applicant seeking approval of a therapeutically equivalent extended-release methylphenidate product may pursue one of four relevant approaches:

Strategy	Principal risk
Paragraph III certification	Defers approval until patent expiration
Paragraph IV certification	Creates potential Hatch-Waxman litigation
Section viii carve-out	Removes patented method language from labeling where legally supportable
Non-infringing formulation	Avoids one or more composition or dissolution limitations

The patent’s method claims create a possible carve-out pathway if the patented weight-based dosing method is not necessary for the proposed generic labeling. That pathway is limited where the approved label, dosing instructions, or product characteristics substantially practice the claimed method.

A generic that uses the same resin-complex architecture and substantially matches the claimed dissolution profile faces greater risk than a product using a different release technology. The PK limitation may complicate early screening because the generic applicant may establish bioequivalence for regulatory purposes while disputing whether the specific claim’s comparison and confidence-interval language is satisfied.

How strong is the patent estate?

The estate is strongest against products that match all of the following:

• racemic methylphenidate;
• ion-exchange resin complexes;
• a coated sustained-release resin-matrix fraction;
• two separate immediate-release fractions;
• the claimed acid-to-neutral dissolution transition;
• the 30-minute release window;
• the weight-based 10 mg to 60 mg dosing table.

Its weaker points are the method-of-treatment format and the dependence on patient administration. A formulation manufacturer alone may not directly infringe a treatment-method claim unless it performs the claimed method or liability is established through induced or contributory infringement theories.

The estate also faces potential challenges based on:

• written description and enablement for the full release-profile range;
• indefiniteness in weight-range boundaries;
• indefiniteness or proof problems concerning the “bioequivalent reference composition”;
• anticipation by earlier methylphenidate resin-complex formulations;
• obviousness based on known immediate-release and sustained-release combinations;
• divided infringement for prescribing and administration steps;
• prosecution-history estoppel arising from amendments.

What litigation and settlement issues matter?

A complete litigation assessment requires docket-level review of Hatch-Waxman complaints, Paragraph IV notices, claim-construction rulings, stipulated dismissals, settlements, licenses, and authorized-generic arrangements.

For business planning, the key questions are:

1. Was Patent 11,166,947 listed for the target NDA?
2. Was a Paragraph IV notice served?
3. Did the NDA holder file within the 45-day statutory period?
4. Was a 30-month stay triggered?
5. Did the parties enter a settlement with an agreed generic launch date?
6. Does the settlement include a license, supply arrangement, or authorized generic?
7. Were any asserted claims dismissed, invalidated, or disclaimed?

A settlement involving an earlier family patent does not automatically resolve Patent 11,166,947. Each listed patent and each claim family must be tested against the settlement’s definitions and release provisions.

How does Patent 11,166,947 compare with competing methylphenidate estates?

Product or technology	Release technology	Main IP distinction
QuilliChew ER	Resin-complex multipart release system	Closely aligned with the Tris formulation estate
Quillivant XR	Extended-release oral suspension	Different dosage-form presentation, but may share platform IP
Concerta	Osmotic delivery system	Uses a different release architecture
Ritalin LA	Bead-based bimodal release	Different multiparticulate technology
Aptensio XR	Multi-layer or bead-based release approach	Different formulation architecture
Jornay PM	Delayed-release and extended-release methylphenidate	Distinct timing and release profile
Generic ER methylphenidate	Product-specific	Risk depends on formulation and listed patents

The key distinction is not merely active ingredient identity. It is whether the competing product reproduces the claimed resin-complex, barrier-coating, immediate-release, dissolution, and dosing combination.

Key Takeaways

• U.S. Patent 11,166,947 is a method patent covering weight-based ADHD treatment with a specific racemic methylphenidate resin-complex formulation.
• Claim 1 requires all major formulation, dissolution, PK, and dosing limitations.
• Claim 2 covers physician-assisted prescribing using the same weight-based dosing chart and the claim 1 dosage form.
• The most restrictive technical limitation is the 30% to 33% cumulative release requirement within 30 minutes under the specified USP Apparatus 2 assay.
• The PK limitation requires only one listed parameter to meet the 80% to 125% confidence-interval requirement, but the reference composition and study conditions may be contested.
• The patent family is expected to run into 2027, subject to the official USPTO term calculation.
• Generic risk is highest for products using the same methylphenidate-ion exchange resin and coated-matrix architecture.
• The principal legal vulnerabilities are claim construction, bioequivalence-reference ambiguity, weight-range boundaries, obviousness, enablement, and method-of-treatment enforcement.
• Orange Book status and Paragraph IV exposure must be assessed against the specific NDA and product, not methylphenidate products as a class.

FAQs

Does Patent 11,166,947 cover all extended-release methylphenidate products?

No. It requires a specific racemic methylphenidate-ion exchange resin architecture, release profile, PK relationship, and dosing method.

Can a generic avoid infringement by using dexmethylphenidate?

Potentially. The claims are directed to racemic methylphenidate formulations. A dexmethylphenidate product would require separate analysis and would not automatically satisfy the racemic methylphenidate limitations.

Does matching the FDA-approved dose automatically infringe the patent?

No. Dose matching alone is insufficient. The product must also satisfy the formulation, dissolution, PK, and administration limitations.

Can a generic use a Section viii labeling carve-out?

Possibly, if the patented dosing method can be omitted from the proposed labeling and the remaining label does not instruct conduct that practices the patented method. The outcome depends on the listed use code and FDA labeling.

Does patent issuance in 2021 extend protection until 2041?

No. Continuation patents generally retain the earlier family term. The controlling expiration date depends on the earliest effective filing date, patent-term adjustment, terminal disclaimers, and any extension reflected in USPTO records.

References

1. United States Patent and Trademark Office. (2021). U.S. Patent No. 11,166,947, Methylphenidate formulations.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (n.d.). QuilliChew ER prescribing information.
4. U.S. Food and Drug Administration. (n.d.). Quillivant XR prescribing information.
5. U.S. Food and Drug Administration. (2017). Draft guidance for industry: ANDAs for certain highly variable drug products.

Drugs Protected by US Patent 11,166,947

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 Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017	AB	RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017	AB	RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-003	Jun 19, 2017	AB	RX	Yes	Yes						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS

Foreign Priority and PCT Information for Patent: 11,166,947

PCT Information
PCT Filed	October 31, 2017	PCT Application Number:	PCT/US2017/059256
PCT Publication Date:	May 11, 2018	PCT Publication Number:	WO2018/085256

International Family Members for US Patent 11,166,947

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017353921
European Patent Office	3585439
Japan	2020504763
South Korea	20190107655
South Korea	20240033130