Details for Patent: 8,574,189

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Which drugs does patent 8,574,189 protect, and when does it expire?

Patent 8,574,189 protects DSUVIA and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,574,189

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:	US13/416,236
Patent Claim Types: see list of patent claims	Delivery; Device; Dosage form;

US Patent 8,574,189: Scope, Claims, Expiration, and Sufentanil Applicator Patent Landscape

US Patent 8,574,189 protects a single-use applicator designed to deliver a small drug-containing tablet, particularly a sublingual sufentanil tablet. Its core technology is a mechanically controlled delivery device with a deformable outlet, a removable safety label, travel-limiting structures, and optional electronic container tracking. The broadest claims are apparatus claims rather than claims to sufentanil itself.

The patent is commercially relevant to Dsuvia, the 30-mcg sublingual sufentanil product approved by the FDA in 2018. The patent estate covers the delivery device and certain device-drug combinations, while separate patents address sufentanil formulations, dosage strengths, tablet properties, and therapeutic use.

What does US Patent 8,574,189 protect?

US Patent 8,574,189, titled “Apparatus and methods for delivery of a drug-containing tablet,” was issued on November 5, 2013. The patent claims an applicator that stores and expels a tablet through a controlled opening in the distal end of the housing. The patent is associated with the AcelRx Pharmaceuticals sufentanil delivery platform.[1]

The independent claims divide the invention into three overlapping device configurations:

Independent claim	Principal subject matter	Key limitations
Claim 1	Applicator with actuation pathway and channel	Delivery member, distal and proximal travel stops, removable safety member, tablet-holding volume
Claim 11	Applicator with deformable outlet	Safety member limits both outlet deformation and delivery-member movement
Claim 18	Applicator with bridge member	Bridge deforms after a threshold delivery force; safety member blocks actuation

The claims are drafted around the interaction of several physical components. A competing device must be analyzed against the complete combination of limitations in at least one asserted claim. Avoiding one structural limitation may defeat literal infringement, although the doctrine of equivalents could remain relevant in litigation.

How does the claimed applicator operate?

The device uses a housing and a movable delivery member. Before actuation, the drug-containing tablet sits in a small volume defined between the distal end of the delivery member and the distal end of the housing.

When the user applies force:

1. The delivery member moves distally through the actuation pathway.
2. A geometric surface on the delivery member engages the distal housing.
3. The distal housing deforms or expands to create an opening.
4. The delivery member pushes the tablet through that opening.
5. The tablet is delivered to the sublingual mucosal membrane.

The design is intended to control both the force and the travel distance required for delivery. The patent does not merely claim a plunger that pushes a tablet. It claims a coordinated mechanical system involving outlet deformation, travel stops, a removable safety element, and, in some claims, a breakable or deformable bridge.

What is the role of the safety member?

The safety member is a central limitation in claims 1, 3, 5, 11, 12, 18 and 21. Claim 2 identifies the safety member as a label coupled to the distal end of the housing.

The safety member performs two functions:

• It prevents or limits distal movement of the delivery member before use.
• It can inhibit deformation of the distal housing and prevent premature opening.

Claim 3 specifically requires the elongate protrusion on the delivery member to contact an edge of the safety member. Claim 12 requires a first portion of the label to be positioned around the distal end of the housing.

This structure supports tamper resistance and prevents unintended tablet release. A device using a removable cap, tab, film, seal or other physical barrier could present an infringement question if it performs the same claimed movement-limiting functions.

What are the most important claim limitations?

Deformable distal outlet

Claims 4, 5, 10, 11, 18, 19, 20 and 21 require or depend on a distal housing that deforms to form or expand an outlet. This limitation distinguishes the claimed applicator from devices that use a preformed aperture, a sliding door, a conventional syringe outlet or a rigid nozzle.

The claim language does not require a specific polymer, wall thickness, deformation angle or opening geometry. The relevant issue is whether the distal housing is configured to deform when the delivery member moves distally and whether that deformation produces the tablet outlet.

Delivery-member travel stops

Claim 1 requires:

• A protrusion that limits proximal movement; and
• An elongate protrusion slidably disposed in a housing channel, with an edge that limits distal movement.

Claims 13, 14 and 16 carry similar travel-stop concepts into claim 11. These limitations control the delivery stroke and help prevent the delivery member from separating from the housing or advancing beyond the intended position.

Bridge member

Claims 6, 15 and 18-21 include a bridge member. The bridge engages the delivery member and either separates from the housing or deforms when the applied force exceeds a predetermined threshold.

This limitation can provide an actuation threshold or an irreversible indication that the device has been used. A competing device without a bridge, frangible connection or equivalent force-responsive structure would have a stronger non-infringement position against claims requiring that feature.

Tablet and dosage limitations

Claims 7, 8 and 17 introduce the drug component. Claim 7 requires a tablet containing sufentanil. Claim 8 specifies sufentanil amounts of 5, 10, 15, 20, 30, 40, 50, 60, 70, 80 or 100 micrograms and requires a tablet volume or mass below 30 microliters or 30 milligrams.

The claim therefore reaches beyond an empty applicator when the accused product includes the specified tablet. Claim 8 is narrower than claim 7 because it includes both dose-selection and size or mass limitations.

Electronic container tracking

Claims 22-24 add a container that at least partially contains the applicator. The container may include:

• A sensor detecting removal of the applicator;
• Memory storing removal data; and
• A port connecting the memory to a computer.

Claim 23 extends the concept to multiple applicators in one container. These claims create a separate enforcement zone around inventory control and use tracking. They are less central to the physical delivery mechanism but could matter for hospital, military or controlled-substance distribution systems.

How strong is the patent estate for the applicator?

The patent has meaningful coverage because it combines several device functions in overlapping independent claims. Claims 1, 11 and 18 are not identical:

Feature	Claim 1	Claim 11	Claim 18
Actuation pathway	Yes	Yes	Yes
Drug-tablet volume	Yes	Yes	Yes
Distal deformable outlet	Dependent limitation	Yes	Yes or dependent
Removable safety member	Yes	Yes	Yes
Safety member limits distal travel	Yes	Yes	Yes
Safety member limits outlet deformation	Dependent	Yes	Dependent
Proximal travel stop	Yes	Dependent	Yes
Channel and elongate protrusion	Yes	Dependent	Not required
Bridge member	Dependent	Dependent	Yes
Electronic container	Claims 22-24	No	Claims 22-24

The strongest practical coverage is directed to a device that uses all of the following: a small tablet chamber, a movable plunger, a deformable distal outlet, a removable safety label, and a bridge or travel-stop mechanism.

The principal vulnerability is claim dependency. Many detailed features appear only in dependent claims. A competitor could potentially design around the claims by using a rigid outlet, a separate cap rather than a label, a preformed dispensing aperture, or a delivery member that does not use the claimed channel and protrusion arrangement.

When does US Patent 8,574,189 expire?

The patent’s expected nominal term runs into 2028, subject to the applicable patent-term adjustment and any terminal disclaimer shown in the USPTO file history. The relevant term is calculated from the earliest effective nonprovisional filing date, not the issue date.

Event	Date or period
Patent issued	November 5, 2013
Expected nominal expiration	2028, subject to USPTO term calculation
Patent type	Utility patent
Patent status relevant to product strategy	Potentially enforceable during the unexpired term, subject to maintenance and term records

A definitive expiration analysis should use the USPTO Patent Examination Data System and Patent Center records, including any patent-term adjustment, disclaimer, reexamination certificate or post-grant proceeding. Issue-date counting would materially understate the remaining term.

What is the Orange Book status of US Patent 8,574,189?

The Orange Book status of this patent must be distinguished from its relevance to Dsuvia.

The FDA Orange Book lists patents submitted by an NDA holder for an approved drug. A device patent may be listed only if it meets the FDA’s drug-product patent-listing standards. A patent directed primarily to an applicator is not automatically an Orange Book patent merely because the applicator is packaged with the drug.

Dsuvia is FDA-approved under NDA 209128 as a sublingual sufentanil tablet administered with a single-dose applicator.[2] The relevant regulatory questions are:

• Whether 8,574,189 was submitted to FDA for NDA 209128;
• Whether FDA accepted the listing;
• Whether the listing covers the drug, the device, or both;
• Whether the listing remains active in the current Orange Book edition; and
• Whether a generic applicant would have to certify to the patent under Hatch-Waxman.

The Orange Book should therefore be checked separately from the USPTO patent record. The patent can remain enforceable against an infringing applicator even if it is not an Orange Book-listed patent.

What patent landscape surrounds Dsuvia and sufentanil tablets?

The product-level patent estate generally falls into four categories:

Patent category	Protected subject matter	Relevance
Applicator patents	Housing, plunger, safety label, deformable outlet and bridge	Device infringement and product configuration
Formulation patents	Sufentanil tablet composition, excipients and dissolution characteristics	Generic formulation risk
Dosage-form patents	Sublingual delivery, tablet size, strength and pharmacokinetic performance	Product and bioequivalence strategy
Method-of-use patents	Administration of sublingual sufentanil for acute pain	Label and induced-infringement risk

US 8,574,189 is primarily an applicator patent. Claims 7, 8 and 17 connect the apparatus to sufentanil, but the patent does not broadly monopolize all sufentanil tablets or all sublingual opioid delivery.

Which companies are challenging the patent?

No specific Paragraph IV challenger or infringement action can be established from the claims alone. A Paragraph IV certification would depend on the patents listed for the relevant Dsuvia reference product and the applicant’s proposed product.

Potential challengers would likely include generic-drug manufacturers pursuing a 505(j) abbreviated new drug application. Their strategies could include:

• Using a different applicator;
• Omitting a deformable distal housing;
• Replacing the label-based safety mechanism;
• Using a pre-opened or rigid dispensing outlet;
• Designing around the bridge member; or
• Seeking a product that uses the drug without the claimed device.

A 505(j) applicant cannot assume that a noninfringing tablet formulation eliminates device risk if the proposed product uses an infringing applicator.

Does biosimilar risk apply to this patent?

No. Sufentanil is a small-molecule active pharmaceutical ingredient. The relevant abbreviated pathway is generally an ANDA under section 505(j), not a biosimilar application under section 351(k) of the Public Health Service Act.

The main regulatory risks are generic substitution, patent certification, formulation equivalence, delivery-device compatibility and controlled-substance compliance. Biosimilar interchangeability is not the applicable commercial framework.

What generic launch scenarios exist?

Scenario 1: Tablet-only or alternative-device launch

A generic applicant could seek a product using a materially different applicator. This would reduce direct risk under the device claims but could create FDA review issues concerning dose delivery, human factors, administration instructions and product performance.

Scenario 2: Same functional architecture

A product with a deformable outlet, removable safety label, plunger travel stops and a bridge member would face the highest infringement risk. Even changes in dimensions may not avoid the claims if the same claimed relationships are present.

Scenario 3: Paragraph IV certification

If 8,574,189 is listed for the reference product and remains unexpired, an ANDA applicant could file a Paragraph IV certification. The NDA holder could respond with patent litigation, triggering the statutory 30-month stay under the Hatch-Waxman framework, subject to the statutory requirements and litigation timeline.

Scenario 4: Post-expiration launch

After expiration, the patent would no longer block an otherwise compliant generic applicator. Separate formulation, dosage-form and method-of-use patents could still delay or limit launch.

What manufacturing and IP barriers does the patent create?

The patent’s practical barrier is not limited to patent claims. A manufacturer must reproduce a device that reliably:

• Holds a very small tablet;
• Prevents premature release;
• Delivers the tablet into the sublingual area;
• Controls actuation force;
• Expands or opens the distal housing;
• Maintains dose integrity during shipping; and
• Meets FDA device and combination-product requirements.

The bridge and safety-label structures may require specialized molding, assembly and quality-control processes. The electronic container claims introduce separate manufacturing and data-integrity requirements, although those claims are narrower and less likely to define the ordinary commercial applicator.

How does this patent compare with formulation and method-of-use patents?

US 8,574,189 is strongest against the device configuration. Formulation patents are stronger against a generic that copies the tablet composition. Method-of-use patents are stronger against a product marketed with a patented administration instruction.

Patent type	Main infringement target	Generic design-around potential
Applicator	Device manufacturer and NDA product configuration	Moderate to high
Formulation	Tablet composition and excipients	Moderate
Dosage form	Tablet size, strength and release properties	Moderate
Method of use	Labeling, promotion and administration	Variable

The patent does not independently establish exclusivity for every 5- to 100-microgram sufentanil tablet. Its narrower tablet claims require the claimed applicator context.

Key Takeaways

• US Patent 8,574,189 is an applicator patent focused on sublingual delivery of a small drug-containing tablet.
• Claims 1, 11 and 18 provide overlapping independent coverage.
• The main technical limitations are the deformable distal outlet, removable safety member, delivery-member travel stops and bridge member.
• Claims 7, 8 and 17 connect the device to sufentanil tablets.
• Claims 22-24 cover container-based removal sensing, memory and computer connectivity.
• The expected patent term extends into 2028, subject to the official USPTO term calculation.
• Dsuvia is the principal commercial product associated with the claimed delivery platform.
• Generic risk depends on both the Orange Book listing status and the design of the proposed applicator.
• Biosimilar analysis does not apply because sufentanil is a small-molecule drug.
• Separate formulation and method-of-use patents may remain relevant even after the applicator patent expires.

FAQs About US Patent 8,574,189

Is US 8,574,189 a drug patent or a device patent?

It is principally a device patent. Its claims cover the applicator structure, although several dependent claims require a sufentanil-containing tablet.

Does the patent cover all sublingual sufentanil products?

No. The broadest claims cover the apparatus. The patent does not broadly claim every sublingual sufentanil tablet, formulation or method of administration.

Can a generic use a different applicator?

Potentially. A different applicator may reduce infringement risk if it avoids the claimed deformable outlet, safety-member arrangement, travel stops and bridge structure. FDA comparability and human-factors requirements would remain separate issues.

Is the patent relevant to Dsuvia exclusivity?

Yes. Dsuvia uses a single-dose applicator to administer sublingual sufentanil. The patent’s commercial relevance depends on its current enforceability and whether FDA accepted it as an Orange Book-listed patent for NDA 209128.

What is the most important design-around feature?

The deformable distal outlet combined with the removable safety member is the most distinctive claim cluster. A rigid outlet or a materially different safety architecture could provide a stronger design-around position, subject to claim-by-claim analysis.

References

1. AcelRx Pharmaceuticals, Inc. (2013). Apparatus and methods for delivery of a drug-containing tablet (U.S. Patent No. 8,574,189). U.S. Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2018). Dsuvia (sufentanil) sublingual tablet prescribing information. NDA 209128.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

4. U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation resources. U.S. Department of Commerce.

5. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. Center for Drug Evaluation and Research.

Drugs Protected by US Patent 8,574,189

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			Y

International Family Members for US Patent 8,574,189

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