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;

Patent landscape, scope, and claims:

US Patent 12,033,733: Scope, Claim Construction, and Sufentanil Drug-Delivery Patent Landscape

US Patent 12,033,733 protects a single-use mechanical applicator for expelling a small drug-containing tablet onto the sublingual mucosa. The independent claims focus on the interaction between the housing, delivery member, internal channel, distal tablet-holding volume, movement stops, and a deformable outlet. Claims 6, 7, 8, and 11 narrow the subject matter to sufentanil tablets, specified dose strengths, small tablet dimensions, and sublingual delivery.

The patent is primarily a device patent. It does not broadly claim sufentanil as a molecule, sufentanil treatment generally, or every sufentanil tablet. Its commercial significance depends on whether the protected applicator is used with the marketed sufentanil product and whether competing products use materially different mechanisms.

What does US Patent 12,033,733 protect?

The patent protects an apparatus with the following required elements:

Claim element	Claims containing the element	Scope
Housing with an actuation pathway	1, 10	Internal path for delivery-member movement
Channel communicating with the pathway	1, 10	Guides an elongate delivery-member protrusion
Tablet-holding volume	1, 10	Formed between distal housing and delivery-member portions
Delivery member moving distally	1, 10	Pushes the tablet out of the volume
Proximal movement stop	1, 10	Delivery-member protrusion engages the housing
Distal movement stop	1, 10	Edge of elongate protrusion engages the channel or housing
Deformable distal housing portion	4, 9, 10	Creates the tablet-exit opening
Bridge that separates from the housing	1	Structural feature associated with actuation
Removable safety member	2	Blocks actuation before use
Concave tablet-contacting portion	3	Dependent limitation
Flexible housing portions	5	Housing deformation or flexure
Sufentanil-containing tablet	6, 11	Narrows the device claims to a drug product combination
Specified sufentanil doses	7	5 mcg to 100 mcg
Tablet volume or mass limitation	7	Less than 30 microliters or less than 30 mg
Sublingual delivery	8	Intended delivery site
Sloped delivery-member surface	9	Deforms the distal housing to form the opening

The broadest practical protection is in claims 1 and 10. Claim 1 requires the bridge-separation structure. Claim 10 requires the delivery member to engage the distal housing and deform it to create the outlet, but does not expressly include the bridge limitation.

How do independent claims 1 and 10 differ?

Claims 1 and 10 share the core applicator architecture but allocate different limitations.

Issue	Claim 1	Claim 10
Housing and actuation pathway	Required	Required
Communicating channel	Required	Required
Tablet-holding volume	Required	Required
Distal delivery movement	Required	Required
Proximal stop	Required	Required
Elongate protrusion and distal stop	Required	Required
Distal housing deformation	Not expressly required in the independent claim	Expressly required
Bridge separating from housing	Required	Not expressly required
Sloped delivery-member surface	Not required	Not required
Sufentanil	Not required	Not required

Claim 1 is structurally broader regarding the mechanism that creates the tablet opening, but it specifically requires the bridge to separate from the housing. Claim 10 expressly requires distal housing deformation and opening creation, while omitting the bridge limitation.

A device may therefore avoid claim 1 by lacking a separable bridge but still infringe claim 10 if it has the remaining claimed features. Conversely, an apparatus with a bridge but no distal deformation may present a stronger claim 1 issue than a claim 10 issue.

What are the key claim-construction issues?

What is the significance of the "volume configured to contain" a tablet?

The claims require a volume formed between portions of the delivery member and housing. The volume must be configured to contain a drug-containing tablet, but the claim language does not require that the tablet be permanently retained, coated, bonded, or loaded during manufacturing.

A competing applicator could face infringement risk if it has a pre-use cavity that temporarily retains the tablet, even if the competing product describes the location as a chamber, recess, pocket, or dispensing compartment.

What does the distal movement limitation require?

The delivery member must move relative to the housing in a distal direction. The elongate protrusion must slide within the channel, and its edge must limit distal movement.

This creates a constrained mechanical relationship rather than a generic plunger claim. A device using a rotating actuator, hinged ejector, spring-loaded member, breakable seal, or non-sliding tablet carrier may have a noninfringement position if it lacks the claimed sliding protrusion and channel arrangement.

What does the deformable outlet limitation require?

Claims 4, 9, and 10 address outlet formation. The distal housing portion must deform when the delivery member advances, producing an opening through which the tablet exits. Claim 9 narrows this mechanism to a sloped surface on the delivery member that engages the housing.

A fixed preformed outlet may avoid the express deformation limitation. A flexible membrane or flap that opens through direct contact may remain within the claim scope if the delivery member and housing satisfy the required structural relationships.

What is the bridge limitation?

The bridge in claim 1 is part of the housing and engages the delivery member. At least part of the bridge separates from the housing when the delivery member moves distally.

This limitation appears designed to capture a tamper-evident or frangible structural feature that changes during actuation. A device with a bridge that remains permanently attached could have a claim 1 noninfringement position, although the rest of the apparatus could still implicate claim 10 or other family patents.

Which claims cover sufentanil and sublingual delivery?

Claims 6, 7, 8, and 11 narrow the apparatus claims.

Claim	Drug or use limitation
6	Drug-containing tablet includes a dosage of sufentanil
7	Sufentanil dose of 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, or 100 mcg; volume below 30 microliters or mass below 30 mg
8	Housing and delivery member enable delivery to a sublingual mucosal membrane
11	Apparatus includes a sufentanil-containing tablet

Claim 7 is unusually specific because it combines a dose list with physical size or mass constraints. A sufentanil tablet outside the listed dose set, or a tablet at or above both the volume and mass thresholds, may avoid claim 7 while still falling within claims 6 or 11 if the other limitations are present.

The claim set does not require a particular excipient, compression force, tablet shape, dissolution rate, bioavailability, packaging system, or manufacturing process. Those issues may be covered by separate formulation, dosage-form, or manufacturing patents.

What products are commercially relevant?

The claims are most closely associated with sublingual sufentanil products such as DSUVIA, a 30-mcg sufentanil sublingual tablet marketed in the United States. The FDA-approved product is administered using a single-dose applicator rather than by direct handling of the tablet. The product is indicated for acute pain in adults in certified medically supervised settings (U.S. Food and Drug Administration [FDA], 2018).

The 30-mcg dose appears within claim 7's enumerated dose range. The commercial product therefore presents a direct product-level relevance to claims 6, 7, 8, and 11, assuming the marketed applicator has the claimed structural features.

Product or technology	Relevance to US 12,033,733
DSUVIA 30-mcg sublingual sufentanil	Principal commercial product potentially using the claimed applicator architecture
ZALVISO sublingual sufentanil system	Related sufentanil delivery technology, but not necessarily the same apparatus
Conventional sublingual tablets	May avoid the claims if no claimed applicator is used
Nasal sufentanil products	Generally outside the sublingual applicator claims
Injectable sufentanil	Outside the apparatus claims unless combined with the claimed device
Generic sufentanil tablets	Risk depends on whether the generic includes the claimed applicator and structural elements

What is the patent landscape for sufentanil delivery?

The relevant landscape has several distinct layers.

How do device patents compare with formulation patents?

Device patents protect the applicator, tablet-retention geometry, actuation system, safety mechanism, and outlet. Formulation patents generally protect the tablet composition, particle size, dosage form, dissolution profile, stabilizers, manufacturing conditions, or pharmacokinetic performance.

US 12,033,733 is narrower than a formulation patent covering all sufentanil tablets, but it can be commercially important because a product may require both the tablet and the applicator. A competitor could avoid this patent with a different delivery system while still facing separate formulation or method-of-use rights.

What other sufentanil technologies are relevant?

The principal adjacent technologies include:

Sublingual sufentanil tablets and dosage forms.
Single-dose applicators that prevent direct patient handling.
Programmable or controlled-access sublingual systems.
Sufentanil formulations designed for rapid transmucosal absorption.
Manufacturing methods for low-dose opioid tablets.
Packaging and tamper-resistance systems.
Methods for treating acute pain in monitored clinical settings.

ZALVISO is a relevant comparator because it uses a controlled sublingual delivery platform, but its system architecture differs materially from a simple mechanical applicator. ZALVISO was developed by Grünenthal and is distinct from DSUVIA's single-dose applicator model.

When does US Patent 12,033,733 expire?

The patent issued on June 11, 2024. Its ordinary expiration date cannot be determined from the claim text alone. US utility patent expiration generally runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and applicable priority claims (35 U.S.C. §§ 154, 156).

The legally relevant date is the patent's adjusted expiration date shown in USPTO records, not simply the issue date plus 20 years. Any patent-term adjustment should be verified in the issued patent and USPTO Patent Center record.

Exclusivity item	Status
Patent type	US utility patent
Patent number	US 12,033,733
Issue date	June 11, 2024
Statutory patent term	Generally 20 years from earliest effective nonprovisional filing
Patent-term adjustment	Must be checked in USPTO records
Patent-term extension	No extension can be inferred from the claim text
FDA NCE exclusivity	Not established by this device patent
FDA orphan exclusivity	Not established by this device patent

What is the Orange Book status of US 12,033,733?

A device patent is not automatically listed in the FDA Orange Book. Orange Book listing depends on whether the patent claims the approved drug product or an approved method of use and whether the NDA holder submits the patent in accordance with FDA regulations.

A patent directed primarily to a mechanical applicator may be absent from the Orange Book even when the applicator is supplied with the drug. Patent listing status must be checked against the current Orange Book entry for the relevant sufentanil NDA and FDA's patent-listing data.

If listed, the patent could support a Paragraph IV certification against an abbreviated new drug application. If not listed, the patent may still be enforceable against an infringing product, but it would not automatically create the Orange Book-based 30-month stay mechanism.

What Paragraph IV and generic-entry risks exist?

A generic applicant seeking approval for a sufentanil product would face different risks depending on its product design.

Device-inclusive generic

A generic that copies the marketed tablet-applicator combination could face infringement allegations under claims 6, 7, 8, and 11, as well as any related device or formulation patents. A Paragraph IV challenge would likely focus on claim construction, anticipation, obviousness, and whether the generic applicator includes each claimed mechanical feature.

Tablet-only generic

A tablet-only product may avoid claims requiring the apparatus, but it could still face formulation or method-of-use patents. Regulatory substitutability and labeling issues would depend on the approved reference product and FDA's device-combination requirements.

Alternative applicator

A competing applicator could reduce risk by using:

A fixed outlet rather than a deformable housing;
A rotary or hinged actuator rather than a sliding delivery member;
No elongate protrusion sliding in a communicating channel;
No breakaway bridge;
A tablet cavity that is not formed between the claimed distal portions;
A different safety mechanism;
A delivery route other than sublingual administration.

Avoiding one limitation does not avoid other patents in the same family or separate patent families.

Which companies are likely to be relevant?

Company	Relevance
Patent owner or assignee identified in USPTO records	Controls prosecution, licensing, and enforcement rights
DSUVIA commercial rights holder	Controls marketed sufentanil product and applicator strategy
AcelRx-related entities	Historically associated with DSUVIA and sublingual sufentanil development
Grünenthal	Developer of ZALVISO and a relevant competitor in sublingual sufentanil delivery
Generic pharmaceutical manufacturers	Potential challengers if pursuing sufentanil tablet or combination-product approval

Ownership, assignment, and licensing should be distinguished. The patent's current owner may differ from the original applicant, and commercial rights may be held by a licensee.

What litigation and licensing issues affect the patent?

The supplied claim text does not establish any infringement action, Paragraph IV filing, settlement agreement, or license involving US 12,033,733. Because the patent issued in 2024, its litigation exposure may arise through later generic filings, ANDA litigation, commercial launch activity, or licensing negotiations.

The most important legal questions are:

Whether the patent is listed for the relevant sufentanil NDA.
Whether the commercial applicator has a breakaway bridge.
Whether its delivery member has both proximal and distal movement stops.
Whether the housing deforms to create the outlet.
Whether the product's tablet meets the claim 7 dose and size limitations.
Whether a related patent family includes earlier-expiring or broader claims.
Whether ownership has transferred to a successor or licensee.

How strong is the patent estate?

US 12,033,733 has meaningful device protection but limited standalone coverage of the drug molecule. Its strength is highest against a competitor that copies the complete mechanical architecture and supplies a small sufentanil tablet for sublingual use.

Its strength is lower against:

Tablet-only competitors;
Non-sublingual products;
Applicators with fixed openings;
Devices using non-sliding mechanisms;
Systems without a separable bridge;
Products with substantially different tablet-retention geometry.

The claim set has two independent apparatus claims, but both require a particular sliding delivery-member and housing/channel arrangement. Claims 6, 7, 8, and 11 create commercially relevant sufentanil limitations but also narrow the infringement case.

Key Takeaways

US 12,033,733 is a mechanical applicator patent, not a broad sufentanil composition patent.
Claims 1 and 10 protect a sliding delivery member, housing pathway, communicating channel, tablet volume, and movement stops.
Claim 1 requires a bridge that separates from the housing during actuation.
Claim 10 expressly requires distal housing deformation to create the tablet outlet.
Claims 6, 7, 8, and 11 connect the device to sufentanil, specified dose strengths, small tablet dimensions, and sublingual use.
A 30-mcg sufentanil product is within claim 7's listed dose range.
Orange Book listing cannot be inferred from the patent claims and must be verified against the relevant FDA NDA record.
Generic risk depends heavily on whether the challenger copies the applicator or markets a tablet-only product.
The principal design-around paths involve changing the outlet, actuator, channel, movement stops, bridge, or delivery route.
The patent's expiration date requires verification of its earliest effective filing date and patent-term adjustment.

FAQs

Does US 12,033,733 claim sufentanil itself?

No. The patent claims an apparatus. Certain dependent claims require that the apparatus contain a sufentanil tablet, but the patent does not claim the sufentanil molecule broadly.

Does a 30-mcg sufentanil tablet automatically infringe claim 7?

No. The product must also be used in an apparatus satisfying all limitations of claim 1 or claim 10, including the housing, channel, sliding delivery member, movement stops, and other structural elements.

Can a generic avoid the patent by selling sufentanil tablets without the applicator?

Potentially, but separate formulation, method-of-use, packaging, or combination-product patents may still apply. Regulatory approval requirements for the reference product also remain relevant.

Is the patent automatically eligible for a Paragraph IV challenge?

No. Paragraph IV certification applies to patents listed in the Orange Book for the relevant reference product. A device patent is not automatically listed.

What is the most important design-around strategy?

The clearest design-around opportunities involve replacing the claimed sliding delivery-member and channel architecture or avoiding the deformable distal housing and separable bridge. A complete freedom-to-operate conclusion requires review of the full patent family and related patents.

References

Food and Drug Administration. (2018). FDA approves new opioid for acute pain in patients who cannot tolerate other pain medications. U.S. Department of Health and Human Services.
Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.
U.S. Patent and Trademark Office. (2024). U.S. Patent No. 12,033,733. United States Department of Commerce.
U.S. Code. (2024). 35 U.S.C. §§ 154-156: Contents and term of patent; patent term adjustment; extension of patent term.
U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

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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			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 12,033,733