Details for Patent: 11,497,711

Which drugs does patent 11,497,711 protect, and when does it expire?

Patent 11,497,711 protects IGALMI and is included in one NDA.

This patent has thirty-six patent family members in sixteen countries.

Summary for Patent: 11,497,711

Title:	Film formulations containing dexmedetomidine and methods of producing them
Abstract:	Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Inventor(s):	Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Scott David Barnhart
Assignee:	EZ Bioxcel Solutions Pvt Ltd , Bioxcel Therapeutics Inc
Application Number:	US17/560,392
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and US Patent Landscape for Drug US 11,497,711 (Dexmedetomidine Buccal Mucoadhesive Dissolvable Film)

What is US 11,497,711 claiming in enforceable terms?

US 11,497,711 claims a single-layer, self-supporting, dissolvable buccal film with mucoadhesive performance and a specific polymer matrix that is restricted to only:

• Water-soluble hydroxypropyl cellulose (HPC) at three defined molecular weights: ~40 kDa, ~140 kDa, ~370 kDa, each with defined wt% ranges
• Water-soluble polyethylene oxide (PEO) at ~600 kDa with a defined wt% range
  and with dexmedetomidine (or a pharmaceutically acceptable salt) applied on one surface of the film substrate.

The claim set also adds dose, thickness, disintegration, mucoadhesion, and method-of-treatment limitations that narrow practical coverage to specific formulation and performance targets.

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What is the independent claim’s core claim language and structural limitations? (Claim 1)

Claim 1 is the primary scope driver. It is structured as:

A. Film type and physical structure

• Self-supporting
• Dissolvable
• Mucoadhesive
• Buccal administration implied in dependent claim set (explicit in claim 3)
• Dexmedetomidine on one surface of a “single layer film substrate”
• Single layer substrate requirement: polymers (HPC and PEO) “together form a single layer film substrate.”

B. Actives

• Dexmedetomidine or pharmaceutically acceptable salt thereof
  • Dependent claims focus on dexmedetomidine hydrochloride.

C. Polymer-only restriction (key enforceability hook)

Claim 1 states:

• “the only polymers present in the film are water-soluble hydroxypropyl cellulose and water-soluble polyethylene oxide polymers” This is a hard exclusion. Any addition of other polymers (including other cellulose derivatives, film formers, tackifiers, or plasticizers that qualify as polymers) risks non-infringement if construed as “polymers present.”

D. Polymer identity and molecular-weight specification

Claim 1 requires:

1. HPC ~40,000 Da
2. HPC ~140,000 Da
3. HPC ~370,000 Da
4. PEO ~600,000 Da

E. Polymer composition ranges (wt% of total film weight)

• HPC 40 kDa: ~3% to ~15% w/w
• HPC 140 kDa: ~3% to ~8% w/w
• HPC 370 kDa: ~10% to ~50% w/w
• PEO 600 kDa: ~40% to ~70% w/w

These ranges drive most design-around space: shifting any polymer outside the ranges, changing the molecular-weight class, or substituting polymer types breaks literal claim coverage.

F. Placement of drug

• Dexmedetomidine (or salt) is “present on one surface” of the substrate.

This placement limitation is critical: formulations where drug is uniformly dispersed throughout the thickness (rather than applied on a surface) may fall outside literal scope. Dependent claims later broaden “multiple isolated surface locations.”

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How do the dependent claims narrow or expand claim scope?

The dependent claims add practical boundaries that make the formulation and performance measurable.

A. Specific drug salt and dose mapping

• Claim 2: Dexmedetomidine HCl at a ratio of ~0.05 to ~3 micrograms per 100 micrograms total film weight.
• Dose-specific claims:
  • Claims 13-17: dexmedetomidine presence at ~10, 20, 30, 40, 60 micrograms (each separate dependent claim).
  • Claims 20-21: dexmedetomidine presence at ~90 micrograms and ~120 micrograms.

B. Composition concentration and film substrate formulation consistency

• Claim 3: Buccal film with an explicit two-part composition:
  • Part (a) composition includes:
  • Dexmedetomidine hydrochloride
  • HPC ~40 kDa
  • HPC ~140 kDa
  • Part (b) substrate includes:
  • HPC ~40 kDa, HPC ~140 kDa, HPC ~370 kDa
  • PEO ~600 kDa
  • Only polymers restriction remains: “only polymers present are water-soluble hydroxypropyl cellulose and water-soluble polyethylene oxide polymers.”
  • Drug on the surface of the substrate (composition of part (a) present on the surface).

This adds a “coating/composition-on-surface” logic: part (a) is a surface-deposited layer that includes only the lower-molecular-weight HPCs plus the drug.

• Claim 4: part (a) constitutes ~0.1% to ~10% w/w of total film weight.
• Claim 5: dexmedetomidine HCl ~0.05% to ~3% w/w of total film weight.
• Claim 6: specific narrow composition example:
  • Dexmedetomidine HCl ~0.1% to ~0.2% w/w
  • HPC 40 kDa ~5% w/w
  • HPC 140 kDa ~5% w/w

C. Film dimensions, disintegration and mucoadhesion performance

• Claim 9: thickness ~20 to ~200 micrometers
• Claim 10: thickness ~20 to ~200 micrometers and area ~100 to ~300 mm²
• Claim 11: disintegration time ~60 to ~180 seconds
• Claim 12: mucoadhesion force ~1000 g to ~2000 g

These are classic “performance-limiting” dependent claims. If the independent claim is broad enough to cover the structure, these dependents can provide fallback positions that reduce validity and infringement risk for those specific benchmarks.

D. Drug placement refinements

• Claim 8: composition part (a) covers a portion of the surface of substrate.
• Claim 7: colorant partitioning (drug layer and substrate different colors).
• Claim 26: dexmedetomidine on one surface and covers more than one isolated surface locations.
• Claim 27: same concept for part (a) coating.

Practically, “one surface” becomes “patchy islands” via claim 26-27. That expands coverage for multi-spot coating rather than a continuous surface layer.

E. Dissolution kinetics (secondary performance fallback)

• Claim 19: film completely dissolvable in oral mucosal fluid in ~1 to ~5 minutes.

F. Treatment claims (method of use)

• Claim 18: method of treating agitation by buccal administration of a film according to claim 1.
• Claims 22-25: total daily dose via one or more units:
  • Claim 22: total daily dose ~120 micrograms
  • Claim 23: total daily dose ~180 micrograms
  • Claim 24-25: same totals but specified as dexmedetomidine hydrochloride totals.

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What is the effective claim scope across formulation “design variables”?

Claim 1 narrows claim coverage more by polymer selection and composition ratios than by process. The main design variables are:

1) Polymer system must be restricted to HPC and PEO

• Literal scope requires “only polymers present” are water-soluble HPC and water-soluble PEO.
• If a competitor adds a polymeric excipient that is legally considered a “polymer” in the film (even at low levels), it becomes a non-infringement lever.

2) Molecular-weight classes are fixed

• Changing HPC grades away from ~40 kDa, ~140 kDa, ~370 kDa breaks the explicit identity limitations.
• Switching to different hydrophilic cellulose derivatives (even similar grades) can break the “hydroxypropyl cellulose” requirement.

3) Polymer wt% windows are tight in combination

Because PEO 600 kDa is ~40% to ~70%, it dominates formulation design space.

• A competitor could keep HPC total constant but adjust PEO outside the range to avoid literal coverage.
• Conversely, keeping PEO within range but pushing HPC 140 kDa outside ~3% to ~8% avoids claim coverage.

4) Drug placement is surface-based

• Claim 1 requires drug on one surface of the single-layer substrate.
• A through-thickness dispersed formulation is a primary non-literal design-around risk area.

5) Thickness/disintegration/mucoadhesion are fallback dependents

Even if a competitor matches structure, they must match performance for dependent claims. Those dependents matter for infringement strategy and claim-scope in litigation because dependent claims can establish infringement for specific embodiments.

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How does US 11,497,711 connect to dexmedetomidine delivery and buccal film prior art risk?

Within the claim structure, the filing implicitly targets a known market need: dexmedetomidine is commonly administered via routes that are not dissolvable buccal films. This creates a prior art landscape split:

• General buccal dissolvable film prior art: broad categories exist (films with mucoadhesive polymers, including HPC-based systems, PEO-based systems, and disintegration-time-focused formulations).
• Specificity risk: the claim narrows to:
  • a restricted polymer set
  • a three-grade HPC/one-grade PEO molecular weight matrix
  • defined wt% bands
  • surface-coated drug placement
  • defined performance windows (in dependents)
  • and a specific use: treating agitation with buccal dosing

In practice, this kind of structure tends to be validated against “generic films” by arguing that the particular polymer blend and surface presentation yields a unique balance of dissolvability and mucoadhesion suited to the drug.

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Where are the legal choke points for freedom-to-operate (FTO)?

A. The “only polymers present” restriction

This is the strongest literal constraint.

• Competitors must confirm what counts as a “polymer” in the film, not only what polymers are intentionally blended.
• Even “processing aids” that form a film and are polymeric can be captured depending on claim construction.

B. Surface-only dosing architecture

If a design uses drug uniformly throughout the film, it may avoid the “present on one surface” limitation, depending on doctrine of equivalents. If it applies drug as a coating or localized deposit, the risk increases.

C. Molecular weight specificity

Competitors often use different commercial grades. If the claim requires “about” the stated molecular weights, then “about” still creates range leeway. But it still constrains to that grade family rather than any HPC.

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How likely is a competitor to design around while keeping buccal film performance?

Using the claim’s explicit parameters, design-around strategies map directly:

1. Swap at least one polymer species outside the allowed list

   • Replace PEO 600 kDa with a different Mw PEO outside the defined Mw, or replace PEO with another film former.

2. Adjust HPC grade molecular weight

   • Use HPC grades not meeting the ~40k/140k/370k classes.

3. Use different polymer composition ratios

   • Push PEO below 40% or above 70%, or move HPC 140 kDa outside 3% to 8%.

4. Change drug distribution

   • Move from “on one surface” to uniform internal distribution or multi-layer films with different architecture.

5. Use different drug form

   • The independent claim covers dexmedetomidine or pharmaceutically acceptable salts, so changing between salt forms only helps if the salt is argued not pharmaceutically acceptable. Dependent claims center on HCl.

6. Performance targets

   • If the formulation is otherwise close, failing thickness/disintegration/mucoadhesion windows could move the embodiment away from dependent claim coverage.

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What does the claim set imply about product manufacturing and coating structure?

Although no process claims appear in the excerpt, the claim language implies a coating-like structure:

• Part (a) composition (dexmedetomidine HCl + HPC 40k + HPC 140k) is present on the surface.
• Part (b) substrate provides mucoadhesive matrix and includes HPC 370k plus PEO 600k.

This suggests a two-component spatial distribution without requiring separate layers in the strictest “multilayer” sense, since Claim 1 insists on “single layer film substrate” while allowing “drug on one surface.”

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Patent landscape mapping: what can be concluded from the claim content alone?

From the claim content provided, the landscape for US 11,497,711 can be organized into three concentric circles of risk. This is not a bibliographic list of other patents, but a claim-driven landscape framework.

Circle 1: Direct claim capture risk (highest)

Products that match all of the following:

• Dexmedetomidine buccal dissolvable mucoadhesive film
• Single-layer substrate containing only HPC and PEO
• HPC at ~40k, ~140k, ~370k with wt% bands
• PEO at ~600k with wt% band
• Dexmedetomidine (or salt) applied to one surface
• (If targeting dependents) thickness/disintegration/mucoadhesion within cited windows

Circle 2: Partial match risk (moderate)

• Film matches polymer matrix but drug is dispersed throughout thickness.
• Film matches structure and drug placement but uses slightly different molecular weights or wt% bands.
• Film matches most elements but does not hit disintegration or mucoadhesion windows for dependent claims.

Circle 3: Low direct infringement risk (but watch equivalents)

• Different film-former systems (additional polymers beyond HPC and PEO)
• Different distribution of drug (not surface-localized)
• Non-buccal route
• Different drug (not dexmedetomidine or its pharmaceutically acceptable salt)

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Where do method-of-use claims concentrate market coverage?

Claim 18 covers:

• Treating agitation
• by buccal administration of a film “according to claim 1.”

That means even if a formulation is similar to match a device or composition claim, infringement risk rises sharply if the product is marketed or used for treating agitation and the film meets claim 1’s formulation and structure constraints.

Daily dose dependents (Claims 22-25) indicate targeted dosing regimens:

• Total daily dose ~120 micrograms
• Total daily dose ~180 micrograms
• Specifically in dexmedetomidine hydrochloride

If competitors use different total daily doses, it may help with dependent claims but not necessarily with claim 1 or claim 18 unless those dependents are asserted.

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Key constraint table (claim 1 to 27 highlights)

Claim	Limitation	Numeric anchors from claim text
1	Polymer set restriction	Only polymers present are water-soluble HPC and water-soluble PEO
1	HPC molecular weights	~40,000 Da; ~140,000 Da; ~370,000 Da
1	PEO molecular weight	~600,000 Da
1	HPC 40k wt%	~3% to ~15% w/w
1	HPC 140k wt%	~3% to ~8% w/w
1	HPC 370k wt%	~10% to ~50% w/w
1	PEO 600k wt%	~40% to ~70% w/w
1	Drug placement	Dexmedetomidine present on one surface of single-layer substrate
2	Drug concentration via ratio	~0.05 to ~3 micrograms per 100 micrograms total film weight (dexmedetomidine HCl)
3	Surface composition composition (two-part structure)	Part (a) dexmedetomidine HCl + HPC 40k + HPC 140k; Part (b) substrate includes HPC 370k + PEO 600k; only polymers are HPC and PEO
4	Part (a) wt%	~0.1% to ~10% w/w of total film weight
5	Drug wt%	~0.05% to ~3% w/w
6	Example narrow composition	Dexmedetomidine HCl ~0.1% to ~0.2% w/w; HPC 40k ~5% w/w; HPC 140k ~5% w/w
9	Thickness	~20 to ~200 micrometers
10	Thickness + area	Thickness ~20-200 µm; area ~100-300 mm²
11	Disintegration	~60-180 seconds
12	Mucoadhesion force	~1000 g to ~2000 g
18	Method of use	Treat agitation via buccal administration
19	Dissolution in mucosal fluid	Completely dissolvable in ~1 to ~5 minutes
22-25	Total daily dose dependents	~120 µg and ~180 µg dexmedetomidine (or HCl)

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Key Takeaways

• US 11,497,711’s enforceable scope centers on a restricted polymer-only system: HPC (40k/140k/370k) + PEO (600k) and no other polymers.
• The independent claim requires surface-localized dexmedetomidine on a single-layer substrate.
• Dependent claims then lock in specific dose windows, thickness/area, disintegration time, mucoadhesion force, and dissolution time, creating practical infringement targets for concrete embodiments.
• The most direct design-around levers are: polymer set expansion, molecular-weight substitution, wt% ratio shifts outside bands, and changing drug distribution away from one-surface placement.

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FAQs

1) Does Claim 1 require a multi-layer film?

No. Claim 1 requires that the polymers “together form a single layer film substrate,” while still requiring dexmedetomidine to be present on one surface.

2) Can a competitor add plasticizers or other excipients without risking infringement?

Claim 1 restricts “the only polymers present” to HPC and PEO. Non-polymeric excipients may be permissible, but any added polymeric material risks breaking the “only polymers present” limitation.

3) How critical is HPC molecular weight selection?

High. Claim 1 requires specific molecular weight classes for three HPC grades, and Claim 3 repeats those requirements.

4) Is surface coating required or can the drug be blended throughout?

Claim 1 requires dexmedetomidine to be “present on one surface.” A uniformly dispersed drug distribution is the most straightforward structural non-infringement route.

5) Does the patent cover treating agitation only by buccal dosing?

Yes. Claim 18 ties the method to buccal administration of a film according to Claim 1.

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References

[1] US Patent No. 11,497,711. “Self-supporting, dissolvable, mucoadhesive film comprising dexmedetomidine for buccal administration.” (Claims 1-27 as provided in the prompt).

Drugs Protected by US Patent 11,497,711

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes	11,497,711		Y			ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	No	11,497,711		Y			ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION

International Family Members for US Patent 11,497,711

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019295699
Australia	2025202163
Brazil	112020026672
Canada	3103431
China	112888431
China	114096880
China	114983979