Details for Patent: 9,066,942

Which drugs does patent 9,066,942 protect, and when does it expire?

Patent 9,066,942 protects TUXARIN ER and is included in one NDA.

Summary for Patent: 9,066,942

Title:	Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer
Abstract:	The disclosed invention is drawn to pharmaceutical tablets that provide delivery of active agents having at least three oxygen-containing groups, as well as a second active ingredient. Non-limiting examples of three oxygen-containing group active agents include guaifenesin, codeine, hydrocodone, and their pharmaceutically acceptable salts. In one embodiment, a pharmaceutical tablet for oral administration once every 12 hours is provided. The tablet includes a first active agent that is a tri-oxy active agent, a second active agent, and a release rate controlling non-ionic oxyl-containing hydrophilic polymer. The total oxyl content of the hydrophilic polymer in the tablet is about 4×10−4 moles to about 2.0×10−3 moles.
Inventor(s):	Chandrashekar Giliyar, Satish Kumar Nachaegari, Chidambaram Nachiappan, Mahesh V. Patel, Srinivansan Venkateshwaran
Assignee:	Spriaso LLC
Application Number:	US14/194,523
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 9,066,942 Scope, Claims, and Patent Landscape (Codeine Phosphate + Chlorpheniramine/Salts + Oxyl-Containing Hydrophilic Polymer Matrix Tablets)

US Patent 9,066,942 claims a specific long-acting, twice-daily solid monolithic matrix tablet therapy for cough/cold. The asserted scope is concentrated in (i) the clinical use (cough/cold symptom treatment), (ii) a two-active combination dose (codeine phosphate plus chlorpheniramine or salt, optionally pseudoephedrine), (iii) a solid monolithic matrix tablet formulation, and (iv) a defined release-rate controlling polymer defined by an oxyl (non-ionic oxyl-containing) hydrophilic polymer architecture and a quantitative oxyl-to-oxygen molar ratio. The patent’s highest-value claim gates are the polymer definition and the release profile (about 12 hours per single dose) combined with the tablet matrix form.

What this patent is trying to protect (plain-terms)

• A modified-release cough/cold combination using codeine phosphate (54 mg) and chlorpheniramine maleate (8 mg) (or chlorpheniramine salt).
• A monolithic matrix tablet with 60 mg to 125 mg of a release-rate controlling non-ionic oxyl-containing hydrophilic polymer.
• A controlled-release mechanism keyed to the polymer’s oxyl group content (quantified in dependent claim 3) and polymer class constraints (HPMC and related celluloses in dependent claims).
• A dosing and duration outcome: twice per day administration, with single-dose coverage of ~12 hours for therapeutic levels and symptom relief.

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How broad is US Patent 9,066,942 claim scope for cough and cold treatment?

Core claim 1 is a method-of-treatment claim for cough/cold patients, tied to administering a very specific composition and schedule. Method claims in the US turn on (a) infringement by use/administration and (b) whether the administered product meets the claim’s structural/formulation constraints.

Claim 1 key limitations (infringement gates)

Claim 1 requires all of the following:

1. Method: “method of treatment … administering to an individual having cough or cold”
2. Dosing frequency: twice a day
3. Composition form: “solid monolithic matrix tablet”
4. Actives and amounts:
   • 54 mg codeine phosphate
   • 8 mg chlorpheniramine maleate (or chlorpheniramine salt)
5. Excipients/material requirement:
   • 60 mg to 125 mg of a release rate controlling non-ionic oxyl-containing hydrophilic polymer
6. Polymer definition: release-rate controlling, non-ionic, oxyl-containing, hydrophilic

The claim is not limited to a specific manufacturing process beyond “solid monolithic matrix tablet,” and it is not limited to a single named polymer in claim 1. That makes it broader than the dependent cellulose/HPMC variants, but narrower than any codeine + chlorpheniramine long-acting product that uses a different release mechanism (coatings, ion exchange resins, different polymer classes, ionic polymers, or non-oxyl release systems).

Practical scope characterization

• Therapeutic area is narrow: cough or cold.
• Product definition is narrow: monolithic matrix tablet + specific mg levels + polymer quantity band.
• Mechanism/chemistry is narrow: non-ionic oxyl-containing hydrophilic polymer.
• Time outcome is tied to the formulation via dependent claims, not fully in claim 1.

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What are the strongest “claim bottlenecks” in US Patent 9,066,942?

The strongest bottlenecks are those that are both chemically specific and economically material for generic/formulation work.

1) Polymer identity and chemistry (claim 1 and claim 3)

• Claim 1 requires a “non-ionic oxyl-containing hydrophilic polymer.”
• Claim 3 adds a measurable quantitative constraint:
  • ratio of “total molar content of oxyl groups in the release rate controlling non-ionic oxyl-containing hydrophilic polymer” to the “total molar content of the oxygen groups in the codeine” is about 2.5 to about 9.0.

This is a major narrowing lever because it pushes the design space toward polymers whose functional group count, as measured in the claim’s terms, falls within range.

2) Specific dose strengths (claim 1)

• 54 mg codeine phosphate
• 8 mg chlorpheniramine maleate
• Polymer loading 60 mg to 125 mg

Any “near” product with different strength (even if clinically similar) will not fit claim 1 as written. If a challenger argues different salt form conversions, claim construction would pivot on whether equivalents exist. As drafted, the claim is anchored to those amounts.

3) 12-hour single-dose coverage (claims 4 and 5)

Claims 4 and 5 require:

• “single dose administration … therapeutic levels … for about 12 hours”
• “single dose administration … symptom relief for about 12 hours”

Even if formulation meets claim 1’s polymer definition, these dependent claims add performance outcomes. If a product shows materially different pharmacokinetics or effect duration, dependent claims can be harder to prove.

4) Matrix tablet architecture (claim 1)

“Solid monolithic matrix tablet” is a structural bottleneck. Products using layered tablets, reservoir devices, coated pellets, or osmotic systems likely fall outside.

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Which dependent claims materially narrow infringement risk? (2, 3, 4, 5, 6, 7, 8, 9)

Claim 2: HPMC as the polymer

• “release rate controlling non-ionic oxyl-containing hydrophilic polymer is hydroxypropyl methylcellulose.”

This makes claim 2 a narrower subset of claim 1. If a generic uses HPMC-like cellulose ethers but not HPMC, claim 2 is avoided, though claim 1 may still capture it if the polymer still meets “non-ionic oxyl-containing hydrophilic polymer” requirements.

Claim 3: oxyl-to-oxygen molar ratio (2.5 to 9.0)

This is the most “quantitative” narrowing. It can be attacked by measurement methodology disputes or by choosing polymers that shift the molar ratio outside the range.

Claim 4–5: ~12-hour therapeutic levels/symptom relief

These are outcome-linked dependent claims. They can be addressed via PK/PD demonstrating shorter or longer duration.

Claim 6: optional pseudoephedrine addition

“composition further comprises pseudoephedrine.”

This claim is narrower than claim 1. A product without pseudoephedrine avoids claim 6.

Claim 7: enumerated cellulose polymers

Polymer can be:

• hydroxypropyl cellulose
• methyl cellulose
• carboxymethyl cellulose
• hydroxypropyl methylcellulose
• or combinations

Note: this expands from HPMC-only (claim 2) to multiple cellulose derivatives. The phrasing still ties back to claim 1’s “non-ionic oxyl-containing hydrophilic polymer” concept, but the list includes carboxymethyl cellulose, which raises the question of ionic character under the patent’s definition. Whether CMC qualifies turns on claim construction and the patent’s definitions in the specification.

Claim 8: HPMC methoxy content 15–30 mole %

This is a chemical specificity gate within HPMC. A generic that selects an HPMC grade outside this methoxy content range may avoid claim 8 while still potentially meeting claim 2 (depending on how “is hydroxypropyl methylcellulose” is construed).

Claim 9: resistant to alcohol extraction

“pharmaceutical composition is resistant to alcohol extraction.”

This adds a stability/extraction-resistance functional requirement. It can be tested experimentally in litigation to argue whether a formulation remains intact or leaches under defined extraction conditions. It is also potentially a manufacturing-process dependent trait.

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What formulation designs are most likely to fall outside US 9,066,942?

Most viable design-around categories

Based on the claim language, the following changes are the most likely to avoid at least one key limitation:

1. Non-matrix architecture: use coatings, coated pellets, osmotic cores, or layered release systems rather than a “solid monolithic matrix tablet.”
2. Different polymer category: use ionic polymers, polyacrylic derivatives, lipids, or other release mechanisms that do not qualify as “non-ionic oxyl-containing hydrophilic polymer.”
3. Different dose strengths: change codeine phosphate or chlorpheniramine salt strength away from 54 mg and 8 mg respectively.
4. Different polymer loading band: polymer mass outside 60 mg to 125 mg.
5. Different dosing profile: single-dose coverage not “about 12 hours” (depending on dependent claim proof).
6. No pseudoephedrine: if trying to avoid claim 6 specifically.

What remains risky

A product that keeps the same actives at the same strengths and uses a monolithic matrix with cellulose ethers in the relevant band is likely to remain exposed to claim 1. Even if performance differs, claim 1 may still be asserted as a product-structure infringement in an administration-based method claim.

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How does US Patent 9,066,942 compare with common US cough/cold combination long-acting IP patterns?

The claim’s technical structure resembles a typical US approach: narrow the claim to a combination of actives + controlled-release matrix + chemical definition of the polymer.

Key differences vs. broader controlled-release drug claims

• Many controlled-release patents for multi-active cough/cold combinations rely on general “controlled release” language. Here, polymer is defined by:
  • non-ionic oxyl-containing hydrophilic nature
  • quantity range and composition ratio constraint (claim 3)
• The tablet is explicitly “solid monolithic matrix,” reducing cross-technology overlap.

Exposure profile vs. generic alternatives

If a potential challenger files an ANDA or 505(b)(2) for a similar cough/cold combination but selects:

• a different strength,
• different release design,
• or a different polymer system not meeting the oxyl criteria, it can reduce infringement risk.

If the challenger targets the same actives and strengths with cellulose-ether matrices, risk stays high because claim 1 does not require HPMC specifically.

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What does the patent claim structure imply for FDA regulatory and Orange Book risk?

Patent 9,066,942 is a method-of-treatment claim for a specific dosage form and dosing regimen. In practice, this type of patent is typically listed to cover:

• the approved drug product’s formulation and/or
• the approved use regimen.

From a generic entry standpoint, Orange Book relevance depends on:

• listing status under the relevant NDA,
• claim scope mapping to the listed formulation and labeling.

If this patent is listed for a marketed NDA for a codeine phosphate + chlorpheniramine maleate controlled-release product with the same dose strengths and dosing instructions, a generic would face:

• potential Paragraph IV exposure if the ANDA label and product match the claim limitations, or
• non-infringement/invalidity challenges if a design-around is used.

This is the highest-level regulatory linkage that follows from the claim text: method claims tied to administration of the coded product.

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How strong is the patent estate around US 9,066,942 based on claim specificity?

No public patent family data is included in the input, so the analysis below is limited to in-claim strength indicators.

Strength indicators in the claims you provided

• High specificity of active doses: 54 mg codeine phosphate + 8 mg chlorpheniramine maleate.
• Material polymer constraints:
  • polymer loading band (60–125 mg)
  • polymer class restriction (non-ionic oxyl-containing hydrophilic polymer)
  • quantitative molar ratio (claim 3)
  • HPMC grade and methoxy content windows (claims 2 and 8)
• Architecture restriction: “solid monolithic matrix tablet”
• Performance outcomes: ~12-hour therapeutic levels and symptom relief (claims 4 and 5)

These features increase the chance that:

• a court will treat claims as relatively narrow and tied to measurable product attributes, and
• design-around space will exist but requires non-trivial formulation change.

Litigation leverage profile

• If an accused product matches the dose strengths and uses the same general cellulose-matrix concept, plaintiffs can use claim 1 and claim 7/2/8 depending on polymer grade.
• If the accused product differs mainly in polymer grade, claim 2/8 become focal.
• If it differs mainly in release duration, claim 4/5 become focal.
• If it differs in polymer chemistry, claim 3 and claim 1’s definition become focal.

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What would a generic entry risk look like for US 9,066,942?

A risk map based strictly on claim limitations:

Highest risk generic scenario

• ANDA/505(b)(2) product is a long-acting, twice-daily monolithic matrix tablet
• codeine phosphate at 54 mg and chlorpheniramine maleate at 8 mg
• uses an oxyl-containing non-ionic hydrophilic polymer, likely HPMC/cellulose ether in a relevant loading range

If the generic’s label instructs twice-daily administration for cough/cold and the PK supports ~12-hour coverage, infringement risk increases for:

• claim 1 and
• claims 4 and 5.

Medium risk scenario

• Product meets dose strengths and matrix form
• but uses a different polymer grade or polymer blend that may or may not meet the oxyl-to-oxygen molar ratio

This scenario targets:

• claim 3 defensibility and measurement/definition issues.
• whether the polymer is still “non-ionic oxyl-containing.”

Lower risk scenario

• Product changes one or more hard gates:
  • different codeine/chlorpheniramine strengths
  • different tablet architecture (not monolithic matrix)
  • different non-qualifying polymer system
  • different dosing frequency/label not twice daily
  • no pseudoephedrine (only affects claim 6)

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Patent landscape gaps: what you can infer without family/Orange Book details

Your prompt requests “Detailed analysis of the scope and claims and patent landscape.” The claim set provided is enough to do a scope analysis, but not enough to build a complete US patent landscape (related family members, continuations, continuations-in-part, prosecution history, licensing settlements, or ANDA litigation) because those require identifying:

• the patent’s publication/application numbers,
• specification definitions for “oxyl,”
• listed Orange Book drug/NDA,
• and the existence of parallel patents in the same family.

Under the constraints here, only scope-level landscape can be inferred from the claim language.

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Key Takeaways

• US 9,066,942 claim 1 is a narrow method-of-treatment claim requiring administration of a twice-daily cough/cold monolithic matrix tablet containing 54 mg codeine phosphate and 8 mg chlorpheniramine maleate (salt allowed) plus 60–125 mg of a non-ionic oxyl-containing hydrophilic release-rate controlling polymer.
• The most critical narrowing features are the polymer chemistry definition and the quantitative oxyl-to-oxygen molar ratio in claim 3, plus the monolithic matrix architecture.
• Dependent claims 4–5 tie infringement to ~12-hour therapeutic/symptom outcomes, creating an evidentiary pathway via PK/PD and clinical endpoints.
• Claims 2 and 8 narrow further to HPMC and HPMC methoxy content (15–30 mole%).
• A credible design-around must change at least one of the hard gates: actives/strengths, monolithic matrix, polymer class/oxyl chemistry, polymer loading, or release duration.

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FAQs

1) Does claim 1 require HPMC specifically?
No. Claim 1 requires a “non-ionic oxyl-containing hydrophilic polymer.” HPMC is specified only in dependent claim 2.

2) Can a product with different codeine strength avoid claim 1?
Yes, on the face of the claim language: claim 1 requires 54 mg codeine phosphate and 8 mg chlorpheniramine maleate (or salt).

3) What limits risk most: polymer identity or polymer oxyl ratio?
Claim 1 sets the baseline polymer type; claim 3 adds the oxyl-to-oxygen molar ratio constraint. Both are material, but claim 3 is the most measurable chemical bottleneck.

4) If a generic achieves 12-hour PK but not 12-hour symptom relief, which claims are implicated?
Claim 4 focuses on therapeutic levels for about 12 hours; claim 5 focuses on cough/cold symptom relief for about 12 hours. A product could potentially map to claim 4 while disputing claim 5.

5) Does absence of pseudoephedrine avoid infringement of all claims?
It avoids the narrower limitation in claim 6 only. Claim 1 and other dependent claims without pseudoephedrine are still potential targets.

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References (APA)

1. United States Patent 9,066,942, “Method of treatment for cough or cold using codeine phosphate, chlorpheniramine, and a non-ionic oxyl-containing hydrophilic polymer matrix tablet,” claims as provided in prompt.

Drugs Protected by US Patent 9,066,942

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No	9,066,942					TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS