Details for Patent: 10,792,246

Which drugs does patent 10,792,246 protect, and when does it expire?

Patent 10,792,246 protects IGALMI and is included in one NDA.

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

Summary for Patent: 10,792,246

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:	US16/453,679
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,792,246: Dexmedetomidine Sublingual Film Claims, Expiry and Patent Landscape

US Patent No. 10,792,246 protects a narrowly defined dexmedetomidine sublingual film platform. Its core limitation is a single-layer, self-supporting, dissolvable mucoadhesive film using four specified water-soluble polymers: three hydroxypropyl cellulose grades and one polyethylene oxide grade. The patent also covers dexmedetomidine loading, film geometry, dissolution, mucoadhesion, isolated drug deposits, color differentiation, and treatment of agitation.

The patent is commercially relevant to IGALMI, the dexmedetomidine sublingual film approved by the U.S. Food and Drug Administration for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.[1] The statutory patent term is expected to run through approximately April 10, 2035, subject to any applicable patent-term adjustment.

What does US Patent 10,792,246 protect?

The patent protects both a product and a treatment method.

Claim 1 is the principal composition claim. It requires every one of the following elements:

Required element	Claim limitation
Dosage form	Self-supporting, dissolvable, mucoadhesive film
Route	Sublingual administration
Active ingredient	Dexmedetomidine or a pharmaceutically acceptable salt
Polymer 1	Water-soluble hydroxypropyl cellulose, approximately 40,000 daltons
Polymer 2	Water-soluble hydroxypropyl cellulose, approximately 140,000 daltons
Polymer 3	Water-soluble hydroxypropyl cellulose, approximately 370,000 daltons
Polymer 4	Water-soluble polyethylene oxide, approximately 600,000 daltons
Polymer restriction	The only polymers are hydroxypropyl cellulose and polyethylene oxide
40,000-dalton polymer	Approximately 3% to 8% of total film weight
140,000-dalton polymer	Approximately 3% to 8% of total film weight
370,000-dalton polymer	Approximately 20% to 40% of total film weight
600,000-dalton polymer	Approximately 50% to 60% of total film weight
Structure	The polymers form a single-layer film substrate
Drug placement	Dexmedetomidine is present on one surface of the substrate

The claim is compositionally narrow but commercially meaningful. A competing product must avoid at least one required limitation to avoid literal infringement. Substituting a different polymer, changing the polymer molecular-weight profile, using a multilayer structure, incorporating a polymer outside the two permitted polymer classes, or placing the active ingredient within the substrate rather than on its surface could create design-around opportunities.

The doctrine of equivalents could still be relevant where a substituted polymer or architecture performs substantially the same function in substantially the same way with substantially the same result. The express restriction that the only polymers are hydroxypropyl cellulose and polyethylene oxide may limit the patentee’s ability to extend the claim to materially different polymer systems.

How do the dependent claims expand patent coverage?

The dependent claims create several commercial fallbacks.

Drug loading and dosage

Claims 2, 5, 6 and 13 through 20 cover dexmedetomidine hydrochloride and specific concentration or dose ranges:

Claim	Covered feature
2	Dexmedetomidine hydrochloride at approximately 0.05 to 3 micrograms per 100 micrograms of film
5	Dexmedetomidine hydrochloride at approximately 0.05% to 3% by weight
6	Approximately 0.1% to 0.2% dexmedetomidine hydrochloride, 5% 40,000-dalton HPC and 5% 140,000-dalton HPC
13	Approximately 10 micrograms per film
14	Approximately 20 micrograms per film
15	Approximately 40 micrograms per film, based on the apparent transcription of “4-0 micrograms”
16	Approximately 60 micrograms per film
19	Approximately 90 micrograms per film
20	Approximately 120 micrograms per film

The dose claims are narrower than the independent composition claim. They are useful against a product that adopts the patented polymer platform but markets different unit doses.

Claims 21 through 24 cover administration of one or more units to provide total daily doses of approximately 120 or 180 micrograms. These claims track the commercial dose strengths and administration patterns associated with IGALMI.[1]

Film performance and physical characteristics

Claims 9 through 12 and 18 cover performance parameters:

Claim	Limitation
9	Thickness of approximately 20 to 200 micrometers
10	Thickness of approximately 20 to 200 micrometers and area of approximately 100 to 300 mm²
11	Disintegration time of approximately 60 to 180 seconds; the supplied text contains a formatting defect before “60 seconds”
12	Mucoadhesion force of approximately 1,000 to 2,000 grams
18	Complete dissolution in oral mucosal fluid in approximately one to five minutes

These limitations can be important in infringement testing because they require laboratory measurement. They also create evidentiary issues concerning test method, substrate, saliva substitute, temperature, force measurement, and whether “about” permits a meaningful margin around the stated range.

Surface drug placement and visual identification

Claims 3 through 8 and 25 through 26 cover a two-part architecture:

1. A film substrate containing the four specified polymers.
2. A separate composition containing dexmedetomidine hydrochloride and the two lower-molecular-weight hydroxypropyl cellulose polymers, applied to the surface of the substrate.

Claim 3 is broader in some respects than claim 1 because it describes the drug-containing composition and film substrate separately. It also requires the same polymer classes and molecular weights but does not state a separate percentage for each polymer in the drug-containing composition.

Claims 7 and 8 cover colorants and partial surface coverage. Claims 25 and 26 cover drug placement at more than one isolated surface location. These claims may reach a product with discrete drug-containing spots, stripes, patches or deposits rather than a continuous drug layer.

How strong is the patent estate for dexmedetomidine sublingual film?

The claim set has strong product-specific coverage but limited breadth outside the defined formulation.

Strengths

The principal strengths are:

• Four-polymer combination defined by molecular weight.
• Required polymer percentages that correspond to film-forming and mucoadhesive performance.
• Explicit single-layer substrate architecture.
• Surface application of dexmedetomidine.
• Separate coverage of film thickness, area, dissolution and mucoadhesion.
• Dose claims aligned with the approved product.
• A treatment claim directed to agitation.

The combination of polymer identity, molecular weight, concentration and architecture is more difficult to design around than a claim directed only to dexmedetomidine in an oral film.

Vulnerabilities

The main vulnerabilities are:

• The molecular-weight limitations may depend on how the polymer is characterized and measured.
• “About” may create claim-construction disputes at the boundaries.
• The claims use broad functional terms such as “self-supporting,” “dissolvable” and “mucoadhesive.”
• The claim text supplied for claim 3 contains punctuation and formatting defects.
• Claims 13 through 20 may be vulnerable if the dose is not consistently measured as free dexmedetomidine, dexmedetomidine hydrochloride or total active pharmaceutical ingredient.
• Claims 11 and 15 contain apparent transcription errors.
• Prior-art risk exists for oral dissolving films, mucoadhesive films, hydroxypropyl cellulose systems, polyethylene oxide systems and dexmedetomidine delivery.

The independent claims are likely to be more valuable in enforcement than the performance claims. A product that uses the same polymer system and surface-loaded dexmedetomidine could infringe claim 1 even if its dissolution time, dose or color differs.

When does US Patent 10,792,246 lose exclusivity?

The patent was issued on October 6, 2020. The application claims an April 10, 2015 priority date. On that basis, the ordinary 20-year patent term is expected to expire on or about April 10, 2035, before accounting for any patent-term adjustment.[2]

Milestone	Date
Earliest stated priority	April 10, 2015
Patent issuance	October 6, 2020
Expected ordinary expiration	Approximately April 10, 2035
FDA approval of IGALMI	April 5, 2022
Approved product	Dexmedetomidine sublingual film

The patent does not receive patent-term extension merely because the product was approved by FDA. Patent-term extension is governed by 35 U.S.C. § 156 and requires satisfaction of statutory conditions.[3] The expected commercial planning date should therefore be treated as the patent’s applicable expiration date after confirmation of the USPTO patent-term adjustment record.

Regulatory exclusivity is separate from patent exclusivity. IGALMI received approval in 2022, but the relevant small-molecule new-drug exclusivity period does not extend to the expected 2035 patent expiration.[1]

What is the Orange Book status of US Patent 10,792,246?

IGALMI was approved under NDA 214375 and is identified by FDA as a dexmedetomidine sublingual film product.[1] US Patent 10,792,246 is associated with the commercial product and is relevant to Orange Book patent-listing analysis.

Orange Book-listed patents can support a Paragraph IV notice and a 30-month stay under the Hatch-Waxman Act if a generic applicant certifies that the listed patent is invalid, unenforceable or will not be infringed, and the patent holder files an infringement action within the statutory period.[4]

The practical significance depends on:

• Whether the patent remains listed for the relevant NDA.
• The listed expiration date.
• The use code attached to any method-of-use listing.
• Whether the generic applicant seeks approval for the same agitation indication.
• Whether the proposed generic film uses the claimed polymer architecture.

A generic applicant seeking approval only for unpatented indications could attempt a section viii statement rather than a Paragraph IV certification. That pathway would not remove a formulation patent that is listed against the drug product itself.

Which companies are challenging the patent?

No publicly established Paragraph IV challenger or federal patent litigation against US Patent 10,792,246 is identified in the supplied record. A definitive current litigation position requires review of FDA Orange Book updates, FDA Paragraph IV notices, PACER filings and district-court docket activity.

The absence of an identified challenger does not eliminate future generic risk. IGALMI is a small-molecule product, and a generic applicant can pursue an ANDA with a noninfringement or invalidity position focused on:

• Polymer molecular weight.
• Polymer percentages.
• Surface versus bulk drug distribution.
• Single-layer versus multilayer construction.
• Dissolution or disintegration parameters.
• The scope of the agitation method claim.
• Written description and enablement of the defined polymer ranges.

What generic entry risks exist for IGALMI?

Generic entry before 2035 would most likely require one of four strategies.

A noninfringing formulation

A challenger could replace one of the four polymers or use different molecular-weight grades. It could also place dexmedetomidine throughout the film rather than on one surface, use a multilayer film, or use a different mucoadhesive matrix.

This strategy carries formulation-development risk. The polymer combination is likely tied to mechanical strength, rapid dissolution and mucosal adhesion. A design-around that avoids the claim may have inferior handling, dose uniformity or residence time.

Paragraph IV invalidity challenge

A challenger could argue that the polymer combination and dosage form would have been obvious based on prior art involving:

• Dexmedetomidine formulations.
• Sublingual or buccal films.
• Hydroxypropyl cellulose as a film former.
• Polyethylene oxide as a mucoadhesive polymer.
• Surface-loaded active pharmaceutical ingredients.
• Oral films with rapid dissolution.

The strongest invalidity case would require a prior-art reference or combination that teaches the particular polymer molecular weights, concentration ranges and surface-loaded architecture, not merely oral films in general.

ANDA with a different indication

A generic applicant might pursue a label that omits the protected agitation use if FDA permits the proposed labeling and the product’s formulation does not infringe the composition claims. This option is weakened when the patent is listed for the product formulation rather than solely for a method of treatment.

Litigation settlement

A settlement could establish a licensed or agreed generic entry date before patent expiration. No publicly established settlement involving this patent is identified in the supplied record.

Does biosimilar risk apply to dexmedetomidine sublingual film?

No. Dexmedetomidine is a chemically synthesized small molecule, not a biologic. Competitive entry would proceed through the ANDA pathway rather than the biosimilar pathway under the Biologics Price Competition and Innovation Act.[5]

The principal regulatory route is therefore an abbreviated new drug application demonstrating pharmaceutical equivalence and bioequivalence to the reference listed drug, subject to the applicable film dosage-form requirements.

What FDA regulatory status does IGALMI have?

FDA approved IGALMI on April 5, 2022, for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.[1]

The approved product uses sublingual films containing 120 micrograms or 180 micrograms of dexmedetomidine. The label provides dosing based on agitation severity and includes safety restrictions associated with dexmedetomidine, including risks of hypotension, bradycardia, somnolence and sedation.[1]

The approved product therefore overlaps directly with claims 13, 20, 21 and 22. Claims 17, 23 and 24 also track the claimed treatment of agitation and 120- or 180-microgram total dosing.

How does this patent compare with competing dexmedetomidine products?

Product	Active ingredient	Dosage form	Primary route	Regulatory position
IGALMI	Dexmedetomidine	Sublingual film	Sublingual	FDA-approved for adult agitation
Precedex	Dexmedetomidine hydrochloride	Intravenous injection	Intravenous	Hospital procedural and intensive-care uses
Generic dexmedetomidine injection	Dexmedetomidine hydrochloride	Injection	Intravenous	Multiple generic suppliers
Dexmedetomidine sublingual-film challenger	Dexmedetomidine	Likely oral film	Sublingual or buccal	Requires separate FDA approval

The patent does not broadly control dexmedetomidine as an active ingredient. It targets a particular delivery system. Injectable dexmedetomidine products generally fall outside the claimed film limitations.

What manufacturing and intellectual-property barriers exist?

The main manufacturing barriers are technical rather than chemical.

A manufacturer must produce a thin, self-supporting film with:

• Uniform dexmedetomidine distribution.
• Adequate tensile strength.
• Controlled moisture content.
• Rapid but reproducible dissolution.
• Reliable adhesion to sublingual mucosa.
• Low-dose content uniformity.
• Stable surface deposition.
• Consistent polymer molecular-weight characteristics.

The surface-loaded architecture may create additional manufacturing steps, including coating, printing, lamination or localized deposition. Those steps can create separate process know-how and trade-secret barriers even when a competitor avoids literal infringement.

Geographic protection is limited to the United States patent rights. Parallel patent rights may exist in Europe and other jurisdictions through the underlying patent family, but foreign scope, prosecution history, validity and expiry must be assessed jurisdiction by jurisdiction. U.S. infringement does not establish infringement in Canada, Europe, Japan or other markets.

What is the commercial exposure from this patent?

The commercial exposure is concentrated in the sublingual dexmedetomidine film market. IGALMI was the first FDA-approved dexmedetomidine product for the acute treatment of agitation in adults with schizophrenia or bipolar disorder.[1]

The patent’s economic value depends on:

• Adoption in emergency departments, psychiatric units and other acute-care settings.
• Reimbursement and hospital formulary placement.
• Physician preference for a noninvasive sublingual product.
• The ability to maintain differentiation from injectable dexmedetomidine.
• The absence of a credible formulation design-around.
• The timing and strength of any Paragraph IV challenge.

Revenue forecasts should not treat the patent as blocking all dexmedetomidine competition. It is more accurate to treat US 10,792,246 as a barrier to a specific sublingual film architecture that may be difficult to reproduce without using the claimed polymer combination.

Key Takeaways

• US 10,792,246 covers dexmedetomidine sublingual films using three specified hydroxypropyl cellulose grades and 600,000-dalton polyethylene oxide.
• Claim 1 is the central product claim and requires a single-layer substrate with surface-applied dexmedetomidine.
• Dependent claims cover dexmedetomidine hydrochloride, 10- to 120-microgram units, 120- and 180-microgram daily dosing, film dimensions, dissolution and mucoadhesion.
• The patent directly overlaps with the formulation and dosing profile of IGALMI.
• The expected ordinary patent expiration is approximately April 10, 2035, subject to patent-term adjustment.
• Dexmedetomidine is a small molecule, so generic competition would proceed through the ANDA pathway, not the biosimilar pathway.
• The most credible design-around strategies involve changing the polymer system, molecular-weight profile, film architecture or drug-placement method.
• No publicly established Paragraph IV challenge or settlement involving this patent is identified in the supplied record.

FAQs

Can a competitor avoid US 10,792,246 by using a buccal film instead of a sublingual film?

Possibly, but the answer depends on the product’s actual administration instructions and claim construction. A film expressly limited to buccal administration may avoid the literal “sublingual administration” limitation, although product claims without a route limitation and the doctrine of equivalents may remain relevant.

Does using dexmedetomidine free base instead of dexmedetomidine hydrochloride avoid the patent?

No automatic exemption exists. Claim 1 covers dexmedetomidine and pharmaceutically acceptable salts. Free-base dexmedetomidine would remain within the active-ingredient limitation if the remaining claim elements are met.

Can a generic use the same polymer classes with different molecular weights?

That is a principal potential design-around route. The competitor would need to establish that its polymers fall outside the claimed approximate molecular-weight ranges and do not otherwise satisfy the claims under their proper construction.

Are the 120- and 180-microgram doses independently protected?

They are expressly recited in claims 20 through 24. The dose claims are dependent on the film architecture of claim 1 or claim 3 and therefore do not independently cover every dexmedetomidine product containing 120 or 180 micrograms.

Does the patent protect the manufacturing process for IGALMI?

The supplied claims are directed primarily to the film, its composition, physical characteristics, drug placement and use in treating agitation. They do not independently claim a manufacturing process. Separate process patents, published applications and trade secrets may provide additional protection.

References

1. U.S. Food and Drug Administration. (2022). IGALMI (dexmedetomidine) sublingual film prescribing information. FDA.

2. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,792,246, dexmedetomidine film compositions. USPTO.

3. 35 U.S.C. § 156. Patent term extension.

4. 21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.

5. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. FDA.

Drugs Protected by US Patent 10,792,246

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			Y			ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	No			Y			ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION

International Family Members for US Patent 10,792,246

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