Details for Patent: 10,905,827

Which drugs does patent 10,905,827 protect, and when does it expire?

Patent 10,905,827 protects XYOSTED (AUTOINJECTOR) and is included in one NDA.

This patent has thirty-five patent family members in twelve countries.

Summary for Patent: 10,905,827

Title:	Injection device with cammed ram assembly
Abstract:	An exemplary embodiment of injector includes a trigger mechanism, an energy source, and a user-operable firing-initiation member. The trigger member can include a trigger member having a retainer portion, and a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom and a trigger engagement member configured to engage the retainer portion of the trigger member in a pre-firing condition. The energy source can be associated with the ram for powering the ram to expel the medicament, and the user-operable firing-initiation member can be operable for causing an axial rotation between the trigger engagement member and the retainer portion from the pre-firing condition to a firing condition in which the trigger engagement member is released from the retainer portion to allow the energy source to fire the ram.
Inventor(s):	Thomas Kramer, Matthew H. Rust, Paul M. Goudreau, Peter A. HOEFT, Julius C. Sund, Peter L. Sadowski
Assignee:	Antares Pharma Inc
Application Number:	US15/157,851
Patent Claim Types: see list of patent claims	Use; Dosage form;

US Patent 10,905,827: Claim Scope, Patent Landscape, Exclusivity and Generic Entry Analysis

US Patent 10,905,827 is an injector-device patent centered on a mechanically triggered, spring- or energy-powered injector with a rotating ram assembly, retractable needle guard, radial trigger interface, post-use lockout, and visual firing indicator. Its broadest protection is structural rather than pharmaceutical. Claim 19 narrows the injector to use with testosterone, but the patent does not claim testosterone, a testosterone formulation, or a method of treating hypogonadism.

The commercial risk is therefore concentrated on manufacturers of compatible autoinjectors, needle-assisted jet injectors, and testosterone products supplied in an injector that uses the claimed trigger and ram architecture. The claims do not, by themselves, create a blocking right over testosterone products delivered through materially different devices.

What does US Patent 10,905,827 protect?

The patent protects a combination of injector components and their functional interaction. Independent claim 1 requires all of the following:

Claim element	Required structure or function
Injector housing	An exterior housing containing the operating components
Container support	At least partly inside the housing and having a projection that fixes it relative to the housing
Medicament container	Associated with the container support
Trigger member	Has a retainer portion
Ram assembly	Has a ram that pressurizes and expels medicament
Trigger engagement member	Engages the trigger retainer in the pre-firing state
Energy source	Powers the ram
Firing-initiation member	Causes relative movement between the engagement member and retainer
Radial opening	Extends through a sidewall of the ram assembly
Opening sidewall	Receives at least part of the firing-initiation member

The radial opening is a material limitation. A competing injector that otherwise uses a rotating ram and trigger may avoid claim 1 if the user-operable firing member does not enter an opening extending radially through the ram assembly sidewall.

Claim 1 is a combination claim. Each limitation must be present in the accused injector for literal infringement. A device that uses a different trigger-release interface, a separate non-rotating ram, or a firing member that acts outside the ram sidewall may have a credible non-infringement position, subject to the doctrine of equivalents.

How do the dependent claims expand the patent’s technical scope?

The dependent claims divide the patent into several technical clusters.

Skin-contact firing and cam-driven rotation

Claims 2 through 4 cover a distal skin-contacting member that moves proximally when pressed against the injection site. Claim 3 adds a first cam on the skin-contacting member and a second cam on the ram assembly. The cam interaction rotates the ram into the firing position.

This cluster targets passive or skin-activated autoinjectors. A device may fall within this group where:

1. The needle guard or skin-contacting member retracts proximally.
2. That movement rotates the ram assembly.
3. Rotation releases the trigger engagement member from the retainer portion.

Claim 4 separately identifies a retractable needle guard that exposes a needle connected to the medicament container. Claims 5 through 8 add needle injection and jet-injection performance.

Jet-injection parameters

Claims 6 through 8 cover jet injection through a needle, including:

• Pressure from 90 p.s.i. to 500 p.s.i.; and
• Average medicament velocity of at least 1,000 cm/sec within the needle.

These claims may be difficult to assess from external inspection alone. Pressure and velocity are performance limitations that generally require testing under specified conditions. The patent text, prosecution history, and claim-construction record would determine whether the measurements apply to a particular phase of operation, fluid viscosity, needle geometry, or test setup.

The pressure range is relatively broad. A device operating below 90 p.s.i. or above 500 p.s.i. may avoid claim 7 if the claim limitation is not met. Claim 8 is independent of the stated pressure range and can apply where the velocity threshold is met without falling within claim 7.

Rotating ram and ram holding structure

Claims 9 through 12 focus on the relationship between the ram, trigger engagement member, and ram holding member.

Claim 9 requires the trigger engagement member and ram to be in fixed association, with rotation of the engagement member rotating the ram. It also requires operation of the firing-initiation member to rotate the ram assembly inside the housing.

Claim 10 adds a ram holding member that retains the ram against the energy source before firing. Claim 11 requires the energy source to overcome the engagement between the trigger engagement member and the ram holding member after release from the retainer portion.

Claim 12 is narrower. It requires a projection on the ram holding member with both a bulge and a groove, with the retainer portion temporarily maintaining engagement with that structure.

This group gives the patent stronger coverage against devices using a staged mechanical release rather than a simple latch. It also creates several design-around routes, including:

• A linearly translating ram;
• A trigger that releases without ram rotation;
• A retaining structure without the claimed bulge-and-groove geometry;
• A trigger engagement member formed separately from the ram; or
• An energy source that does not overcome a ram-holding engagement in the claimed sequence.

Unitary ram assembly and post-injection lockout

Claim 13 requires the ram assembly to be of unitary construction. “Unitary” can raise claim-construction issues because it may refer to a single molded component, a permanently joined assembly, or a structure that operates as one integrated part, depending on the specification and prosecution history.

Claims 14 and 15 cover post-use lockout. The ram assembly engages the container support to lock the injector after injection, and further proximal movement of the firing-initiation member is blocked.

These claims are commercially relevant for single-use injectors because they address reuse prevention and confirmation of an irreversible operating cycle. A reusable injector, or an injector that locks out through a component other than the ram assembly, may avoid this subcombination.

Firing-status indicator

Claims 16 through 18 protect a visual status system. The pre-firing exterior has a color gamut that does not include the indicator color. The indicator color is hidden before firing and becomes visible through a housing window after firing.

Claim 17 places the indicator on the ram assembly. Claim 18 narrows the post-firing condition by requiring the ram assembly to entirely occlude the window after firing.

The claims do not require a particular color, window shape, pigment, or marking material. They instead focus on the relationship between the pre-firing visual state, the hidden indicator, and the post-firing view.

Does the patent cover testosterone products?

Claim 19 recites an injector in which the medicament comprises testosterone. It is a dependent claim and therefore incorporates every limitation of claim 1.

The claim does not cover:

• Testosterone as an active pharmaceutical ingredient in general;
• A testosterone ester or formulation independent of the injector;
• A testosterone treatment method independent of the claimed device;
• A vial, cartridge, or prefilled syringe used in a different injector; or
• A testosterone product using a different firing mechanism.

The commercial importance of claim 19 depends on whether the patented injector architecture is used with a testosterone product. Antares Pharma’s XYOSTED product is a relevant commercial comparator because it is a testosterone enanthate product supplied in a single-dose autoinjector. The existence of a testosterone product does not establish infringement. The accused device would need to satisfy the structural and functional limitations incorporated from claim 1.

What is the likely patent term and exclusivity timeline?

US Patent 10,905,827 was granted on February 2, 2021. A US utility patent generally expires 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments (35 U.S.C. §§ 154, 156).

Event	Date or assessment
Patent grant	February 2, 2021
Patent type	US utility patent
Patent expiration	Depends on earliest effective nonprovisional filing date and term adjustments
Regulatory exclusivity	Not established by the device claims
Orange Book drug-patent exclusivity	Not established by the claims
Biosimilar exclusivity	Not applicable to a testosterone device patent
Generic-device protection	Potentially relevant only through infringement of the issued claims

The grant date is not the expiration date. A reliable expiration calculation requires the complete priority chain, continuity data, patent-term-adjustment record, and any terminal disclaimer. The claims alone do not establish the expiration date.

The patent’s exclusivity is also distinct from FDA regulatory exclusivity. A device patent can remain enforceable after a drug’s regulatory exclusivity ends, while a drug can remain commercially protected through patents that are unrelated to the injector.

What is the Orange Book status of US Patent 10,905,827?

The supplied claims are directed to an injector, not to a drug substance, drug composition, or therapeutic method. On that claim language, the patent is not a conventional Orange Book patent for testosterone enanthate or another testosterone formulation.

FDA Orange Book listing rules focus on patents that claim the approved drug substance, drug product, or approved method of use. Device-related patents may raise separate listing questions where the device is integral to the approved drug product, but a device patent is not automatically an Orange Book-listed patent merely because it is used to deliver a drug (FDA, 2024).

The practical regulatory conclusions are:

• Claim 19 does not convert the patent into a testosterone composition patent.
• The patent does not support a Paragraph IV challenge by itself unless it is listed against a specific approved drug product.
• A generic applicant would need to review the applicable product’s actual Orange Book listings, labeling, device configuration, and patent certifications.
• FDA approval of a competing testosterone product does not determine infringement of this patent.

Does this patent create Paragraph IV risk?

Paragraph IV risk depends on whether the patent is listed in the Orange Book for the reference drug and whether the proposed generic product is required to certify against it. A device-only patent generally presents a different analysis from a listed formulation or method-of-use patent.

For a testosterone autoinjector, the relevant questions are:

Issue	Effect on risk
Patent listed against the reference product	Can create a certification and litigation pathway
Patent not listed	Usually no direct Orange Book Paragraph IV certification against this patent
Generic uses different injector	Reduces infringement exposure
Generic copies the ram and trigger architecture	Increases device-patent exposure
Generic uses a prefilled syringe or vial	May avoid the injector claims
Generic label includes testosterone use	Does not alone satisfy the structural limitations

A product applicant can face patent litigation outside the Hatch-Waxman framework if it manufactures, sells, or induces use of an infringing injector. The absence of an Orange Book listing would not necessarily eliminate ordinary patent-infringement exposure.

How strong is the patent estate?

The supplied claims indicate a focused device estate rather than a broad pharmaceutical estate.

Strengths

The patent has several potentially valuable features:

1. Claim 1 combines the ram, trigger, container support, and radial opening.
2. Claims 2 and 3 cover passive skin-triggered cam rotation.
3. Claims 9 through 12 cover a specific release and holding sequence.
4. Claims 14 and 15 address irreversible post-use lockout.
5. Claims 16 through 18 cover visible firing confirmation.
6. Claim 19 links the device to testosterone without claiming the drug itself.

The combination of mechanical geometry and operating sequence can make direct copying easier to identify when the competitor’s device is transparent, disassembled, or subject to technical testing.

Limitations

The estate also has identifiable weaknesses:

• Claim 1 is structurally dense and requires multiple interacting elements.
• The radial opening limitation may create a straightforward design-around.
• Claims 7 and 8 depend on measurable performance thresholds.
• Claim 19 has no independent force apart from claim 1.
• The claims do not cover all autoinjectors, all jet injectors, or all testosterone delivery systems.
• The patent does not claim the active ingredient, formulation, dose, or therapeutic indication independently.

The practical strength of the patent will depend heavily on the specification’s disclosure, prosecution amendments, cited prior art, and any terminal disclaimer or continuation-family patents.

Which products and companies are most exposed?

The highest exposure is for companies commercializing single-use injectors that combine:

• A fixed internal container support;
• A ram driven by a spring or other energy source;
• A trigger engagement member retained before firing;
• A radially arranged firing interface;
• A proximal-moving needle guard;
• Cam-driven ram rotation;
• A needle-assisted jet-injection mode; and
• A mechanical lockout after use.

Competitive categories

Product or platform type	Relative exposure
Testosterone autoinjector using the claimed architecture	High, if all claim 1 limitations are present
Passive needle-guard autoinjector with rotating ram	High to moderate
Needle-assisted jet injector with different trigger geometry	Moderate
Conventional spring autoinjector with linear plunger	Lower
Prefilled syringe with manual injection	Low
Vial-and-syringe presentation	Low
Wearable injector with electronic actuation	Depends on mechanical equivalence
Reusable injector	Lower for claims 14 and 15, but not necessarily for claim 1

Antares Pharma and products associated with the XYOSTED testosterone delivery platform are commercially relevant comparators. Other device manufacturers can be exposed if their products use the same mechanical architecture, regardless of whether they market testosterone, another small molecule, or a biologic.

Biosimilar risk is limited. Testosterone is a small-molecule drug, and the patent does not claim a biologic molecule or biologic formulation. The relevant competition is generic-drug and drug-device competition, not biosimilar substitution.

What manufacturing and intellectual-property barriers exist?

The patent’s manufacturing relevance lies in the precision required to produce the trigger and ram interface. Potential barriers include:

• Molding or machining the ram-sidewall opening;
• Maintaining dimensional tolerances for the trigger locking projection;
• Controlling cam surfaces and rotational release;
• Ensuring consistent spring force and release timing;
• Integrating the container support with the housing;
• Achieving the claimed jet pressure or velocity; and
• Producing an irreversible lockout without premature activation.

These features can create freedom-to-operate issues even where a competitor can technically design around the patent. A design-around may require a new mold set, new injection-force validation, human-factors testing, reliability testing, and potentially a new FDA submission or supplement.

Manufacturing know-how does not expand the patent claims. Process details are relevant only where they cause the manufactured product or its use to satisfy the issued claim limitations.

What litigation or licensing conclusions follow from the claims?

No litigation, settlement, or licensing terms are contained in the claim language. The patent claims alone cannot establish:

• Whether the patent has been asserted;
• Whether a court has construed the claims;
• Whether a continuation or divisional remains pending;
• Whether a license exists;
• Whether a settlement includes a launch date;
• Whether the patent is subject to a covenant not to sue; or
• Whether the patent has been challenged through inter partes review.

For transaction and litigation analysis, the key legal documents are the complete patent family, prosecution history, assignment records, maintenance-fee status, PTAB docket, district-court docket, and any FDA listing. Those documents control the commercial assessment more directly than the issued claims.

How can a competitor design around US Patent 10,905,827?

The most direct design-around options target claim 1 rather than the narrower dependent claims.

Mechanical design-around options

A competitor could consider:

1. A ram that translates without rotating.
2. A trigger that releases the ram through axial translation.
3. A firing member positioned outside the ram sidewall opening.
4. A ram assembly without a radial through-opening.
5. A separate trigger component that is not in fixed association with the ram.
6. A latch that releases without the claimed retainer-and-engagement sequence.
7. A container support fixed by housing ribs rather than the claimed projection.
8. A lockout mechanism operated by the needle guard or housing rather than the ram.
9. A visual indicator independent of the ram assembly.
10. A pressure or velocity profile outside the limitations of claims 7 and 8.

Each option requires a full claim chart. A design that avoids one dependent claim may still infringe claim 1 or another independent claim in the patent family.

Key Takeaways

• US Patent 10,905,827 is primarily an injector-mechanism patent.
• Claim 1 requires a specific housing, container support, trigger, ram, energy source, and radial ram-sidewall opening.
• Claims 2 through 4 cover proximal needle-guard movement and cam-driven ram rotation.
• Claims 6 through 8 address needle-assisted jet injection, including 90 to 500 p.s.i. and at least 1,000 cm/sec.
• Claims 14 and 15 cover post-injection lockout.
• Claims 16 through 18 cover a visual fired-status indicator.
• Claim 19 narrows the injector to testosterone but does not claim testosterone independently.
• The patent does not, from the supplied claims, create broad protection over testosterone formulations or methods of treatment.
• Orange Book and Paragraph IV consequences depend on the patent’s actual listing status for a particular reference product.
• Biosimilar risk is not the principal issue because the patent claims a small-molecule delivery device.
• The strongest design-around opportunities concern the radial opening, ram rotation, trigger-release sequence, and ram-based lockout.
• The February 2, 2021 grant date does not establish the patent’s expiration date.

Frequently Asked Questions

Does US Patent 10,905,827 cover XYOSTED?

It may be relevant to an injector used with XYOSTED only if the commercial device satisfies every limitation of an asserted claim. Claim 19 identifies testosterone, but the patent does not cover all XYOSTED formulations or all testosterone delivery systems.

Can a generic testosterone product avoid this patent by using a prefilled syringe?

A prefilled syringe may avoid the injector claims if it does not include the claimed housing, container support, ram assembly, trigger engagement structure, and radial opening. The complete product configuration must be analyzed.

Is the 90 to 500 p.s.i. range required for every claim?

No. The pressure range appears in claim 7, which depends on claim 6 and ultimately claim 1. Claim 1 itself does not require jet injection or a specified pressure.

Does a color indicator alone infringe the patent?

No. Claims 16 through 18 require the broader injector structure of claim 1 and the specified relationship among the pre-firing color gamut, hidden indicator, housing window, and post-firing visibility.

Is US Patent 10,905,827 a drug patent or a device patent?

It is a device patent based on the supplied claims. Its claims are directed to an injector and its operation, with testosterone appearing only as a dependent medicament limitation.

References

1. United States Patent and Trademark Office. (2021). U.S. Patent No. 10,905,827, Injector.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. 35 U.S.C. § 154. Patent term.
4. 35 U.S.C. § 156. Extension of patent term.
5. 21 C.F.R. § 314.53. Submission of patent information.

Drugs Protected by US Patent 10,905,827

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 10,905,827

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013203784
Canada	2868500
Canada	2900672