Details for Patent: 9,241,910

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Which drugs does patent 9,241,910 protect, and when does it expire?

Patent 9,241,910 protects DEXILANT SOLUTAB and is included in one NDA.

This patent has thirty-one patent family members in twenty-six countries.

Summary for Patent: 9,241,910

Title:	Orally-disintegrating solid preparation
Abstract:	The present invention provides an orally-disintegrating solid preparation such as a tablet produced by tabletting fine granules showing controlled release of a pharmaceutically active ingredient and an additive, and the like, and the orally-disintegrating solid preparation containing fine granules coated with a coating layer containing a polymer affording a casting film having an elongation at break of about 100-about 700%. With the preparation, breakage of fine granules during tabletting can be suppressed in the production of an orally-disintegrating solid preparation containing fine granules showing controlled release of a pharmaceutically active ingredient.
Inventor(s):	Takashi Kurasawa, Yasuko Watanabe, Yoshihiro Omachi
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US12/921,731
Patent Claim Types: see list of patent claims	Formulation; Compound; Delivery; Dosage form;

US Patent 9,241,910: Scope, Claim Construction, Expiration, and Dexlansoprazole Patent Landscape

US Patent 9,241,910 protects a tablet containing two populations of R-lansoprazole, also known as dexlansoprazole, with different release profiles. The independent claim requires a tightly defined combination of controlled-release fine granules, enteric fine granules, polymer compositions, particle-size limits, dissolution performance, and tablet format.

The patent is more difficult to design around than a conventional active-ingredient or single-layer enteric-coating patent because infringement requires reproducing multiple formulation elements in combination. Its commercial relevance depends on whether the patented orally disintegrating tablet has regulatory approval or whether an approved product uses the claimed architecture.

What patent protects R-lansoprazole orally disintegrating tablets?

US 9,241,910 is directed to an orally disintegrating solid preparation containing two types of fine granules:

Element	Fine granules A	Fine granules B
Active ingredient	R-lansoprazole or a salt	R-lansoprazole or a salt
Core	Active-containing core granules	Active-containing granules
Release profile	Controlled release	Enteric and comparatively different release
Key polymer	Methacrylic acid-methyl acrylate-methyl methacrylate copolymer	Enteric polymer plus sustained-release substrate
Particle size	500 micrometers or below	500 micrometers or below under claim 2
Form	Incorporated into a tablet	Incorporated into the same tablet
Functional result	No more than 10% dissolved at two hours in pH 1.2, and no more than 5% at one hour in pH 6.8	Delayed or modified release through the enteric coating

The patent’s technical concept is a multi-population delivery system. Fine granules A provide a highly restricted release profile, while fine granules B use a separate enteric and sustained-release system. The tablet is designed to disintegrate rapidly in the mouth while retaining modified-release behavior after swallowing.

The public patent record identifies US 9,241,910 as a Takeda-related patent directed to an orally disintegrating preparation containing R-lansoprazole-based granules. The patent should be analyzed separately from patents covering the active compound itself, conventional delayed-release capsules, or other dexlansoprazole dosage forms. (United States Patent No. 9,241,910, 2016)

What does independent claim 1 require?

Claim 1 is a combination claim. Each listed limitation must generally be present for literal infringement.

1. A tablet

The preparation must be “in the form of a tablet.” A capsule, sachet, suspension, conventional orally disintegrating film, or multiparticulate-filled capsule would not literally satisfy this limitation without a claim-construction theory treating the alternative dosage form as equivalent.

The tablet must also be orally disintegrating. The claim does not require a specific commercial disintegration standard in claim 1, but dependent claim 9 requires an oral disintegration time of 90 seconds or less.

2. Fine granules A containing R-lansoprazole

Fine granules A must include:

• A core granule containing R-lansoprazole or a salt;
• An intermediate coating layer;
• A controlled-release film over the intermediate layer;
• An average particle size of 500 micrometers or less.

The intermediate layer must contain at least one specified polymer, including hydroxypropyl cellulose, hypromellose, polyvinylpyrrolidone, polyvinyl alcohol, methylcellulose, or hydroxyethylmethylcellulose.

The intermediate layer must be present at 0.02 to 1.5 parts by weight per part of core granules. This numerical range is a material limitation. A formulation using the same polymer but outside the range could avoid literal infringement, subject to doctrine-of-equivalents analysis.

3. A specific controlled-release film

The controlled-release film must contain a methacrylic acid-methyl acrylate-methyl methacrylate copolymer capable of producing a casting film with 100% to 700% elongation at break.

This limitation is narrower than a generic “methacrylate copolymer” requirement. The identity of the copolymer and the mechanical-property test are both relevant. A formulation using ethylcellulose, cellulose acetate, a different methacrylate polymer, or a polymer outside the stated elongation range may present a design-around position, although the full formulation and equivalence analysis would control.

4. Specific dissolution performance for fine granules A

Fine granules A must release:

• No more than 10% of the active ingredient in two hours in pH 1.2 solution; and
• No more than 5% in one hour in pH 6.8 solution.

These are unusually restrictive performance limitations. They shift infringement analysis from ingredient identity alone to validated dissolution testing. Testing conditions, apparatus, agitation speed, sampling, assay method, granule isolation, and calculation method can materially affect the result.

5. Fine granules B with a different release rate

Fine granules B must contain the same active ingredient but have a different release rate from fine granules A. They must be enteric-coated and use:

• An aqueous enteric polymer base; and
• A sustained-release substrate.

The enteric polymer base must be at least one of:

• Methacrylic acid-ethyl acrylate copolymer;
• Hydroxypropyl methylcellulose acetate succinate; or
• Carboxymethyl ethyl cellulose.

The sustained-release substrate must be at least one of:

• Methyl methacrylate-ethyl acrylate copolymer; or
• Ethylcellulose.

The claim also requires an enteric coating that is soluble at pH below 6.0 but not at pH below 5.0. This pH language creates a technical boundary that may require comparative dissolution testing rather than reliance on the trade name or nominal grade of the polymer.

How do dependent claims expand the patent scope?

Claim	Added limitation	Commercial significance
2	Fine granules B have average particle size of 500 micrometers or below	Extends the particle-size architecture to both granule populations
3	A:B active-ingredient weight ratio of 1:10 to 10:1	Covers balanced and substantially unbalanced release populations
4	Addition of an additive	Broadens tablet composition
5	Additive includes a water-soluble sugar alcohol	Covers common orally disintegrating-tablet excipients
6	Additive includes a disintegrant	Targets rapid tablet breakup
7	10-50 wt% A, 10-30 wt% B, and 20-80 wt% additive	Adds a quantitative composition window
8	Total tablet weight of 1,000 mg or below	Covers practical oral dosage formats
9	Oral disintegration time of 90 seconds or less	Establishes a measurable ODT performance requirement
10	Gastric pH reaches at least 4 within 0.5 hours and remains at that level for at least 14 hours	Claims a prolonged gastric-acid-suppression effect
11	30 mg dose reaches maximum blood concentration in five hours and maintains at least 100 ng/mL for four hours or longer	Adds a pharmacokinetic profile

Claims 3, 7, 9, 10, and 11 are particularly relevant to product development because they define commercial performance, not merely composition. A formulation could contain the required polymers but fall outside these dependent claims if its ratios, disintegration time, pharmacokinetics, or gastric-pH profile differ.

What patent expiration date applies to US 9,241,910?

The patent’s nominal term is governed by the US patent-term rules applicable to the earliest effective US nonprovisional filing date, subject to patent-term adjustment, terminal disclaimer, and any patent-term extension. The grant date alone does not determine expiration. (USPTO, n.d.-a)

The patent was issued on January 26, 2016. Based on the patent family’s approximately 2009 US filing period, the ordinary expiration window is expected to fall around 2029, before accounting for any patent-term adjustment. The controlling date should be confirmed in USPTO Patent Center and the patent’s continuity data. A regulatory patent-term extension would generally be relevant only if the patented product and approved indication satisfy the statutory requirements.

Exclusivity timeline

Event	Date or period
US patent grant	January 26, 2016
Ordinary patent term	Approximately 20 years from the relevant US nonprovisional filing date
Expected ordinary expiry window	Approximately 2029
Small-molecule regulatory exclusivity	Separate from patent term and dependent on the relevant NDA
Patent-term adjustment	Must be confirmed in USPTO records
Biosimilar exclusivity	Not applicable

The patent is not a biologic patent. Dexlansoprazole is a small molecule, so a competing manufacturer would generally use the ANDA pathway rather than the biosimilar pathway under section 351(k) of the Public Health Service Act.

What is the Orange Book status of US 9,241,910?

The FDA Orange Book lists patents associated with approved drug products and approved conditions of use. Listing depends on the relationship between the patent claims and the approved NDA product, not merely on ownership of a patent covering the same active ingredient. (FDA, n.d.-a)

Dexilant is an FDA-approved delayed-release oral dosage form of dexlansoprazole under NDA 022287. The approved commercial product has historically been a delayed-release capsule, while US 9,241,910 requires an orally disintegrating tablet. That dosage-form distinction is material.

The principal Orange Book questions are:

1. Whether US 9,241,910 is listed against NDA 022287.
2. Whether the NDA holder certified that the approved product practices the patent.
3. Whether the approved product has the claimed tablet architecture.
4. Whether the listing covers an approved method of use or only a formulation.
5. Whether the patent remains active on the current Orange Book publication date.

A patent directed to an unapproved ODT formulation may not be listable against an approved delayed-release capsule if the approved product does not fall within the patent claims. Conversely, a patent can create ANDA litigation risk if the NDA holder lists it and the proposed generic is represented as infringing.

When does a generic manufacturer face Paragraph IV risk?

A Paragraph IV certification is relevant only when a patent is listed in the Orange Book for the reference drug. The generic applicant must address each listed patent through a certification or statement under the Hatch-Waxman framework. (FDA, n.d.-b)

Scenario 1: The patent is not Orange Book listed

If US 9,241,910 is not listed for the relevant NDA, it would not ordinarily create a Paragraph IV certification obligation for an ANDA applicant. The patent could still support a separate infringement action if the marketed generic practices the claims.

Scenario 2: The patent is listed

A generic applicant could assert that the patent is:

• Not infringed;
• Invalid under sections 102, 103, or 112;
• Unenforceable; or
• Not applicable to the proposed dosage form.

A Paragraph IV notice could trigger a 45-day period for the patent owner or NDA holder to file suit. A timely action may create a 30-month stay of approval, subject to statutory exceptions and later court decisions. (21 U.S.C. § 355(j))

Scenario 3: The generic uses a different dosage form

A delayed-release capsule applicant has a stronger noninfringement position against a claim expressly requiring a tablet. The position weakens if the applicant’s product is an orally disintegrating tablet containing the same dual-granule architecture and the claimed polymer systems.

How strong is the patent estate for dexlansoprazole?

US 9,241,910 has a technically narrow but commercially meaningful claim set.

Strength factor	Assessment
Active ingredient limitation	Narrow because it requires R-lansoprazole or a salt
Dosage-form limitation	Narrow because claim 1 requires a tablet
Granule architecture	Strongly limiting and potentially difficult to prove without formulation records
Polymer limitations	Narrow and chemically specific
Dissolution limitations	Important for infringement and validity testing
Functional pharmacokinetic claims	Potentially valuable but vulnerable to reproducibility and written-description challenges
Design-around potential	Moderate to high for products using capsules, different polymers, different ratios, or different release testing results
Litigation leverage	Highest against an ODT that copies the two-population formulation
Biosimilar exposure	None

The strongest enforcement theory would target a competing orally disintegrating tablet that uses both fine-granule populations, the specified methacrylate and cellulose-based polymers, and comparable pH-dependent dissolution. The weakest theory would target a conventional dexlansoprazole delayed-release capsule lacking the tablet and granule requirements.

What validity issues could affect US 9,241,910?

Obviousness

A challenger could combine prior art on:

• R-lansoprazole;
• Enteric-coated lansoprazole granules;
• Orally disintegrating tablets;
• Methacrylate controlled-release films;
• Dual-release multiparticulate systems; and
• Sugar-alcohol-based ODT excipients.

The patentee’s strongest response would be an unexpected result tied to the specific polymer combination, dissolution profile, gastric-pH control, or pharmacokinetic profile.

Written description and enablement

Claims 10 and 11 create potential scrutiny because they recite physiological and pharmacokinetic outcomes. The specification would need adequate support across the claimed formulation scope, particularly across the broad polymer alternatives and wide A:B ratio range.

Indefiniteness

Potential disputes include:

• The meaning of “different release rate”;
• The test used to determine elongation at break;
• The pH conditions defining enteric solubility;
• The method used to measure average particle size;
• The specific dissolution protocol; and
• Whether the gastric-pH and blood-concentration limitations are sufficiently objective.

Anticipation

A single prior-art reference would need to disclose the combination of two active-containing granule populations, the specified coatings and polymers, the tablet, and the functional limitations. A reference disclosing only delayed-release lansoprazole capsules would likely not anticipate claim 1 as written.

What licensing deals and litigation affect this patent?

The patent record alone does not establish a license, settlement, covenant not to sue, or litigation disposition. No licensing right should be inferred from patent ownership, product distribution, or the existence of an NDA.

For transaction diligence, the material documents are:

• USPTO assignment and ownership records;
• Any recorded security interest;
• Orange Book listing history;
• ANDA litigation complaints and judgments;
• Paragraph IV notices;
• Settlement agreements involving the patent;
• FDA approval records for the relevant dosage form; and
• Any terminal disclaimer or post-grant proceeding.

A settlement involving another dexlansoprazole patent would not automatically resolve US 9,241,910. Each patent requires separate claim, listing, and release analysis.

How does US 9,241,910 compare with conventional Dexilant patents?

US 9,241,910 differs from conventional dexlansoprazole patent protection in four ways:

1. It focuses on an orally disintegrating tablet rather than a standard delayed-release capsule.
2. It requires two distinct fine-granule populations.
3. It specifies polymer chemistry and physical properties.
4. It claims release, gastric-pH, and pharmacokinetic outcomes.

The conventional commercial product presents a greater risk from patents covering the active ingredient, delayed-release capsule technology, or broad pharmaceutical compositions. US 9,241,910 presents its greatest risk to an ODT or multiparticulate tablet that deliberately reproduces the claimed architecture.

What generic launch scenarios exist?

Low-risk launch

A manufacturer develops a delayed-release capsule using a single granule population, avoids the claimed ODT format, and uses a different release mechanism. The manufacturer must still assess other dexlansoprazole patents.

Intermediate-risk launch

A manufacturer develops an ODT but uses one active-containing granule population, a different enteric polymer, or a release profile outside the claim limitations. Testing and prosecution history would determine the strength of the noninfringement position.

High-risk launch

A manufacturer develops an ODT containing:

• Fine granules A and B;
• R-lansoprazole;
• The claimed methacrylate film;
• The specified enteric polymer and sustained-release substrate;
• Granules no larger than 500 micrometers; and
• The claimed dissolution profile.

That product would require a detailed claim chart, laboratory testing, prosecution-history review, and Orange Book certification analysis before launch.

Key Takeaways

• US 9,241,910 is a formulation patent for an orally disintegrating dexlansoprazole tablet.
• Claim 1 requires two R-lansoprazole fine-granule populations with different release rates.
• The claim includes specific polymer classes, particle-size limits, coating weights, pH behavior, and dissolution results.
• The patent is materially narrower than a patent covering dexlansoprazole generally or a conventional delayed-release capsule.
• The ordinary patent-expiry window appears to be approximately 2029, subject to USPTO-confirmed term adjustment and continuity data.
• Biosimilar litigation is irrelevant because dexlansoprazole is a small molecule.
• Paragraph IV exposure depends on Orange Book listing and the relationship between the claimed ODT and the approved reference product.
• The most credible design-around strategies involve changing the dosage form, eliminating one granule population, using different polymers, or moving outside the numerical release and composition limits.
• The patent’s highest commercial value is against a competing orally disintegrating tablet that copies its dual-granule architecture.

FAQs

Does US 9,241,910 cover all dexlansoprazole products?

No. It requires a tablet containing two specified populations of fine granules and additional coating, polymer, particle-size, and dissolution limitations.

Can a delayed-release capsule infringe US 9,241,910?

Literal infringement of claim 1 is less likely because the claim expressly requires a tablet. Other dexlansoprazole patents may still apply to a delayed-release capsule.

Is R-lansoprazole the same active ingredient as dexlansoprazole?

Yes. Dexlansoprazole is the R-enantiomer of lansoprazole, generally administered as the active pharmaceutical ingredient in delayed-release products.

Does the 500-micrometer limitation apply to both granule populations?

Claim 2 expressly applies the limitation to fine granules B. Claim 1 expressly imposes the average-particle-size limitation on fine granules A.

Are method-of-use patents the main risk for a dexlansoprazole generic?

Not for this patent. US 9,241,910 is principally a formulation and dosage-form patent, although dependent claims 10 and 11 add physiological and pharmacokinetic performance limitations.

References

1. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (n.d.-b). Abbreviated new drug application regulations and patent certifications. U.S. Department of Health and Human Services.

3. United States Patent No. 9,241,910. (2016). Orally disintegrating preparation. United States Patent and Trademark Office.

4. United States Patent and Trademark Office. (n.d.-a). Patent term adjustment and patent term calculation. U.S. Department of Commerce.

5. 21 U.S.C. § 355(j). (2024). Abbreviated applications for new drugs.

6. U.S. Food and Drug Administration. (n.d.-c). Dexilant: Prescribing information, NDA 022287. U.S. Department of Health and Human Services.

Drugs Protected by US Patent 9,241,910

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 9,241,910

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2008-061673	Mar 11, 2008
Japan	2008-334920	Dec 26, 2008

PCT Information
PCT Filed	March 10, 2009	PCT Application Number:	PCT/JP2009/054983
PCT Publication Date:	September 17, 2009	PCT Publication Number:	WO2009/113703

International Family Members for US Patent 9,241,910

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	070863
Australia	2009224254
Brazil	PI0909439
Canada	2717947
Chile	2009000557
China	102026627