Details for Patent: 12,033,733

Which drugs does patent 12,033,733 protect, and when does it expire?

Patent 12,033,733 protects DSUVIA and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 12,033,733

Title:	Storage and dispensing devices for administration of oral transmucosal dosage forms
Abstract:	Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.
Inventor(s):	Andrew Poutiatine, Bruce Edwards, Charles Rampersaud, Pamela Palmer, Bradley Blackwood, Benjamin K. Yaffe
Assignee:	CITO MECHANICAL DESIGN Inc , Vertical Pharmaceuticals LLC
Application Number:	US18/141,689
Patent Claim Types: see list of patent claims	Use; Delivery; Device; Dosage form;

US Patent 12,033,733: Scope, Claim-by-Claim Boundaries, and US Landscape Implications

US Patent 12,033,733 is directed to a single-use or actuated drug delivery apparatus that expels a drug-containing tablet from a housing volume by moving a delivery member distally. The claims focus on mechanical structure and travel-limiting features that (i) retain a tablet in a defined chamber, (ii) prevent premature distal actuation, (iii) create an expulsion opening by deforming the housing distal end, and (iv) manage relative motion using protrusions and a slidable/edge-limited elongate member. The patent also claims specific subject matter where the tablet contains sufentanil and where delivery targets sublingual mucosal tissue.

What is the core invention claimed in plain structural terms?

The apparatus has three functional blocks that appear repeatedly across claims:

1. A housing with an actuation pathway and a channel

   • The housing defines:
     • an actuation pathway
     • a channel in communication with the actuation pathway
   • The housing distal end portion interacts with the distal end portion of the delivery member to create an opening for tablet expulsion (via deformation).

2. A movable delivery member that expels a tablet

   • A delivery member sits in the actuation pathway such that:
     • its distal end plus the housing distal end define a volume containing the tablet
     • distal movement expels the tablet from that volume.

3. Mechanical travel control and housing release/opening generation

   • Proximal direction limiting:
     • The delivery member includes a protrusion engaging the housing to limit proximal movement.
   • Distal travel limiting:
     • The delivery member includes an elongate protrusion that is slidably disposed within the channel, with an edge configured to limit distal movement relative to the housing.
   • Distal end deformation and opening:
     • The housing distal portion is configured to deform when the delivery member moves distally, producing an opening for expulsion.
   • Separable bridge (claim 1 specific):
     • The housing includes a bridge that engages the delivery member and is configured to be separated from the housing when the delivery member moves distally.

How broad is claim scope? It is a mechanical device claim with drug and target add-ons

Claim scope is “device-first.” Drug identity and dosing are in dependent claims (6-7, 11). Delivery-site targeting is in dependent claim 8.

That makes the patent potentially easier to design around at the pharmacology layer (change drug) but harder to avoid if a competitor makes the same kind of deformable housing opening + tablet chamber + travel limiting features.

A useful way to model breadth is to split the claim into:

• Mandatory structural elements (present in independent claim 1 and/or independent claim 10)
• Optional/dose-specific elements (dependent claims)
• Optional delivery target (dependent claim 8)

Claim 1: Element-by-element scope and what each limitation buys the patentee

Independent claim 1 defines a full apparatus with the separation-bridge feature and multiple motion-limiting features.

Core mandatory limitations (Claim 1)

Claim 1 requires all of the following:

1. Housing

   • Housing defines:
     • an actuation pathway
     • a channel in communication with the actuation pathway

2. Delivery member within actuation pathway

   • A portion of the delivery member is disposed within the actuation pathway such that:
     • the distal end of the delivery member and the distal end of the housing define a volume configured to contain a drug-containing tablet
     • the delivery member moves distally relative to the housing to expel the tablet from the volume.

3. Proximal movement limiting via protrusion

   • Delivery member has a protrusion configured to engage the housing to limit movement relative to the housing in the proximal direction.

4. Distal movement limiting via an elongate protrusion in the channel

   • Delivery member includes an elongate protrusion that is slidably disposed in the channel
   • An edge of the elongate protrusion limits distal movement of the delivery member relative to the housing.

5. Housing bridge that separates upon distal actuation

   • Housing includes a bridge configured to engage the delivery member
   • At least a portion of the bridge is configured to be separated from the housing when the delivery member moves distally.

Claim 1 functional consequences

• The bridge separation suggests a manufacturing break, latch release, or staged safety feature where distal actuation causes a bridge to part.
• The combination of (i) bridge separation and (ii) proximal and distal travel limiting defines a very specific actuation event boundary.

What Claim 1 likely covers that competitors should watch

• Devices where a tablet sits in a distal chamber and a plunger-like member drives it out through a deformable outlet.
• Mechanisms that use:
  • a breakable/separable bridge for staged release
  • channel-guided travel limiting via a slidable protrusion edge.

Claim 2: Pre-actuation safety member (narrow but important in practice)

Claim 2 depends on claim 1 and adds:

• A removable safety member configured to engage the delivery member to prevent distal movement prior to removal.

This is a typical safety interlock concept, but as a dependent claim it tightens infringement to devices that use a removable safety feature that directly blocks distal actuation.

Claim 3: Concave distal end (narrow mechanical contour)

Claim 3 depends on claim 2 and requires:

• The distal end portion of the delivery member includes a concave portion.

This is likely a contouring detail that improves tablet contact and expulsion reliability. It also gives a clear non-infringement pathway for designs using a convex/flat distal surface.

Claim 4: Deformable distal housing producing an opening (explicit expulsion port generation)

Claim 4 depends on claim 1 and requires:

• The distal end portion of the housing is configured to deform when the delivery member moves distally to produce an opening through which the tablet can be expelled.

This limitation is central to the patent’s mechanical concept. If a competitor uses a rigid aperture already open, or uses a different expulsion port generation method (e.g., a hinged gate or a sliding sleeve), this may avoid “deform to produce an opening.”

Claim 5: Housing split into first and second portions with flexibly deforming part (materials/structure path)

Claim 5 depends on claim 1 and adds:

• Housing includes a first portion and a second portion
• Collectively they define the actuation pathway
• At least one of the portions is configured to flexibly deform.

This is another detail that ties the deformation to a particular structural arrangement. A competitor with an integral housing may fall outside if the “first and second portion” requirement is not met (though courts can treat some designs as equivalent if claim interpretation is broad, depending on prosecution history).

Claim 6: Tablet contains sufentanil (drug identity limitation)

Claim 6 depends on claim 1:

• A drug-containing tablet disposed in the volume
• The tablet includes a dosage of sufentanil.

This is a meaningful narrowing: a generic competitor delivering another opioid or non-opioid is outside claim 6 and likely claim 7 and 11 too.

Claim 7: Specific sufentanil dose set and tablet size constraints (very narrow dependent constraints)

Claim 7 depends on claim 6 and requires:

• Sufentanil dosage selected from: 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 100 mcg
• Tablet volume < 30 microliters OR tablet mass < 30 mg

This is tight. Infringement requires both the dose set match and the size constraint, unless the device uses a dose outside the enumerated group (then claim 7 likely does not read).

Claim 8: Delivery to sub-lingual mucosal membrane (target/indication use limitation)

Claim 8 depends on claim 1:

• Housing and delivery member are configured to enable delivery of the tablet to a sublingual mucosal membrane.

For apparatus claims, a “configured to enable” limitation can be satisfied by structure intended for sublingual placement, even without an explicit “method of use” claim. Still, it gives a design freedom: devices not designed for sublingual placement may reduce risk.

Claim 9: Sloped surface on delivery member for deforming distal housing opening (interaction surface detail)

Claim 9 depends on claim 1:

• Distal end portion includes a sloped surface
• The sloped surface is configured to engage the distal end housing to deform it and produce the opening.

This narrows the way the opening is produced. If a competitor uses a flat face or a different geometry (e.g., rounded boss), this could create a non-infringement position.

Claim 10: Independent claim alternative without the bridge separation and with explicit sloped engagement

Independent claim 10 defines a similar apparatus but differs in key structural limitations and wording.

Mandatory limitations (Claim 10)

It requires:

1. Housing defining actuation pathway and channel
2. Delivery member movable distally to expel tablet from a volume defined by distal end portions of delivery member and housing
3. Distal end portion of delivery member configured to engage distal end portion of housing to:
   • deform the distal end portion
   • produce an opening for expulsion
4. Delivery member includes:
   • protrusion engaging housing to limit proximal movement
   • elongate protrusion slidably disposed within channel
   • edge of elongate protrusion limiting distal movement

Key difference vs claim 1

• Claim 10 does not include the claim 1 bridge separation element.
• Claim 10 includes the deform-and-open interaction directly in the independent claim text.

Practical implication

If a competitor avoids the bridge concept but still uses:

• deformable distal housing that forms an expulsion opening
• channel-guided elongate protrusion with an edge limiting travel they may still fall within claim 10.

Claim 11: Sufentanil dependent on claim 10

Claim 11 depends on claim 10:

• Tablet contains sufentanil.

It does not import the enumerated dose set or size restriction found in claim 7.

What does this mean for infringement risk and design-around strategy?

Highest-risk design commonality

The strongest risk cluster is mechanical:

• A tablet chamber at a distal interface
• Distal motion expels the tablet
• Deformable housing forms an opening
• Travel-limiting structure uses channel/elongate protrusion edge
• Proximal movement limited via protrusion

Most obvious carve-out levers

Competitors can reduce risk by breaking one of these independent-claim essentials:

1. Avoid bridge separation (claim 1 specific)

   • Eliminates one claim path but not necessarily claim 10.

2. Avoid deforming distal housing to create an expulsion opening

   • If expulsion occurs through a pre-formed rigid aperture or a non-deforming mechanism, claim 4 and claim 10’s “deform to produce an opening” may not read.

3. Avoid the channel + slidable elongate protrusion with an edge limiting distal movement

   • If the device uses a different distal stop scheme (e.g., fixed end-stop, mechanical cam lock, stop pin not involving a slidable elongate protrusion in a channel), risk drops.

4. Avoid sloped surface engagement (claim 9 only)

   • Helps narrow dependent claims but does not defeat independent claims 1 or 10 if the independent claim does not require a sloped surface.

5. Change drug identity

   • Avoid claim 6/7/11 by using a different active, at least for those drug-containing dependent claims.

6. Change dose or tablet size constraints

   • Helps avoid claim 7 specifically, but does not avoid claim 6 or claim 11.

Coverage map: claim dependencies

Claim	Independent dependency	Key narrowing themes
1	none	bridge separation + motion limits + channel elongate edge
2	1	removable safety member
3	2	concave distal delivery end
4	1	deform distal housing to make opening
5	1	housing split into first/second portions with flex deformation
6	1	tablet includes sufentanil
7	6	dose set + tablet volume/mass constraint
8	1	sublingual mucosa delivery configuration
9	1	sloped surface on delivery end
10	none	deform distal housing to make opening; no bridge separation limitation
11	10	tablet includes sufentanil

US patent landscape: where this will collide (and how to position searches)

You provided the claims but not the full patent specification text, priority data, prosecution history, or inventor/assignee. Without those, a complete citation-grade landscape map (by family members, CPC classes, and nearest citations) cannot be verified from the record you supplied alone.

Still, the claim structure points to likely crowded technical neighborhoods in the US:

1) Sublingual opioid delivery devices with tablet-format dosing

CPC search targets (for your landscape work):

• A61M (medical apparatus for administering medicaments)
• A61K (pharmaceutical compositions)
• A61J (devices for delivering medicaments)

You will want to filter on:

• “tablet expulsion,” “sublingual,” “mouth dissolvable” (even if the tablet is expelled rather than dissolved)
• “single-use applicator,” “actuated delivery,” “plunger mechanism”

2) Actuated expulsion mechanics with deformable outlet/port formation

Mechanical novelty here sits in:

• deformable housing distal end that creates an opening during actuation
• channel-guided travel limitation using a slidable protrusion with an edge stop
• bridge/latch separation that releases upon actuation

CPC search targets:

• components in A61M devices: “disposable,” “actuator,” “housing,” “flexible,” “deformable,” “latch,” “breakable,” “safety lock”

3) Sufentanil combination products and device-specific claims

Landscape collision points likely include:

• drug product patents for sufentanil dosing
• and device patents for opioid delivery (especially those claiming specific dosing regimens or tablet formats)

Your search approach should separate:

• drug composition patents (composition, dosing, formulation) from
• device patents (delivery apparatus, actuation, expulsion)

This patent is a device claim that incorporates sufentanil as a limitation, not a formulation-only claim.

What to do next: a defensible landscape workflow for US 12,033,733

To convert this into a litigation-grade freedom-to-operate and validity map, build a claim-chart and then run structured US prior-art and family searches.

A. Claim chart build (minimum set)

For each candidate competitor design, map these elements:

• actuation pathway + channel
• distal tablet chamber defined by distal ends
• distal motion expels tablet
• proximal protrusion limits proximal travel
• elongate protrusion slidably disposed in channel; edge distal stop
• deformable distal housing creates opening (claim 4 / claim 10)
• bridge separation (claim 1 only)
• removable safety member (claim 2 only)
• sloped surface (claim 9 only)
• sufentanil and the dose set/size constraints (claims 6-7, 11)

B. Search in US for nearest mechanical art

• CPC: A61M + device actuation + flexible/deformable structures
• Keywords: “tablet expel,” “actuated,” “deformable housing,” “expulsion opening,” “safety lock removable,” “bridge,” “latch break,” “channel guided slider,” “distal stop edge”
• Use “sublingual” filter when relevant

C. Search for sufentanil tablet device patents

• Pull US applications that cite sufentanil and sublingual delivery systems.
• Then check whether they claim mechanical expulsion devices vs sublingual sprays/films/patches.

D. Validate claim interpretation with prosecution and specification

Key items that can change scope:

• how “bridge configured to be separated” is interpreted
• whether deformation must be of the housing distal end specifically
• whether the “channel” is structural or could be construed as a groove/track formed by portions of the housing

Key Takeaways

• US 12,033,733 is primarily a mechanical actuation and tablet expulsion patent: a distal chamber expels a tablet through an opening produced by deformation, with channel-guided motion limiting and, in claim 1 only, a bridge that separates during distal actuation.
• The highest-leverage infringement determinants are likely:
  • deformable housing that forms an opening during distal actuation (independent claim 10; dependent claim 4)
  • the specific channel + elongate protrusion + edge distal travel-limiting structure
  • the presence or absence of a bridge separation feature (claim 1)
• Drug limitations are concentrated in dependent claims:
  • sufentanil in claims 6 and 11
  • specific dose set and size limits in claim 7.
• Practical design-around options target mechanical features (opening generation and motion limiting) rather than dose, because independent claims can read without importing the dose set.

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FAQs

1) Does US 12,033,733 require the drug to be sufentanil in the independent claims?

No. Claims 1 and 10 do not require sufentanil. Sufentanil appears in dependent claims 6 and 11, and the specific dose set and size appear in claim 7.

2) Is the bridge separation limitation required for all independent claim coverage?

No. The bridge separation limitation is in claim 1 only. Claim 10 omits the bridge separation element.

3) What is the single most important mechanical limitation to map in competitor designs?

The mechanism that produces an opening through deforming the distal housing during distal actuation (explicit in claim 4 and built into claim 10).

4) If a competitor uses a rigid pre-made outlet hole, can they avoid the claims?

It can. If expulsion uses an outlet that is not produced by deforming the distal housing “to produce an opening,” it may fall outside the “deform to produce an opening” limitations in claim 4 and claim 10.

5) Does avoiding claim 1’s bridge feature automatically avoid infringement of claim 10?

Not automatically. A device can avoid claim 1 while still meeting claim 10 if it still includes the deformable opening and channel-guided elongate protrusion with an edge stop.

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References

1. United States Patent No. 12,033,733 (claim set provided by user).

Recent additions to Drugs Protected by US Patent 12,033,733

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET	209128	Nov 2, 2018	DISCN	Yes	12,033,733	Y

Drugs Protected by US Patent 12,033,733

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	12,033,733		Y

International Family Members for US Patent 12,033,733

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2010107761