Details for Patent: 10,357,609

Which drugs does patent 10,357,609 protect, and when does it expire?

Patent 10,357,609 protects XYOSTED (AUTOINJECTOR) and is included in one NDA.

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

Summary for Patent: 10,357,609

Title:	Needle assisted jet injection device having reduced trigger force
Abstract:	An exemplary embodiment of an injector includes a trigger mechanism, an energy source, and a user-operable firing-initiation member. The trigger mechanism can include a floating trigger member having a retaining portion, a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom, the ram assembly further having a floating trigger engagement member configured to engage the retaining portion of the floating trigger member when the floating trigger member is 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 of the floating trigger member from the pre-firing condition to a firing condition in which the floating trigger engagement member is released from the retaining 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, Michael Travanty, Patrick Madsen
Assignee:	Antares Pharma Inc
Application Number:	US15/155,804
Patent Claim Types: see list of patent claims	Dosage form;

United States Drug Patent 10,357,609: Claim Scope, Enforceability, and Patent Landscape

U.S. Patent No. 10,357,609 protects a mechanically triggered injector architecture rather than testosterone as a chemical compound. Independent claim 1 requires a floating trigger, a ram assembly, an energy source, and an end-cap ram-holding structure that temporarily restrains the ram until firing. Dependent claims narrow the device to needle-assisted or jet injection, defined pressure and velocity ranges, automatic lockout, visual firing indication, and androgen delivery, including testosterone cypionate and testosterone enanthate.

The patent is most commercially relevant to prefilled testosterone autoinjectors such as XYOSTED, but its broadest claims are not limited to testosterone. A competing product may infringe claims 1-16 without delivering an androgen if it uses the claimed trigger and ram architecture. Claims 17-20 create a narrower product-use combination directed to androgen injectors.

What does U.S. Patent 10,357,609 protect?

The patent protects a combination of mechanical structures and firing relationships. Claim 1 is the principal scope-defining claim.

Claim element	Required technical feature	Scope implication
Injector	A device for expelling medicament	Applies to an injector, not merely a syringe
Floating trigger member	Trigger member with a retaining portion	Requires relative movement or freedom from rigid fixation
Ram assembly	Ram pressurizes a medicament container	The ram must act on the container to expel medicament
Floating trigger engagement member	Engagement structure associated with the ram assembly	Must engage the trigger retaining portion before firing
Energy source	Powers the ram	The claim is compatible with springs or another stored-energy mechanism
User-operable firing-initiation member	Causes the trigger to move	Firing cannot occur solely through an internal automatic event
End cap and ram holding member	Axially retains the ram in the pre-firing state	The end cap participates in the safety and release architecture
Pre-firing engagement	Trigger retains the engagement member against firing	Requires a restrained, armed condition
Firing condition	Engagement is released and the energy source overcomes the holding interaction	The release sequence is central to infringement

The claim is therefore directed to a coordinated release mechanism. A device with a spring-driven ram alone would not necessarily infringe. The accused product would need to include the claimed trigger-retention and end-cap interaction, or an equivalent structure under the doctrine of equivalents.

The supplied claim language contains an apparent drafting ambiguity in the phrase stating that “the ram is disengaged from the retaining portion.” Earlier portions of claim 1 place the retaining portion on the floating trigger member and the engagement member on the ram assembly. A court would likely construe the limitation in the context of the full claim, specification, prosecution history, and related family claims. The distinction between disengagement of the ram assembly’s engagement member and disengagement of the ram itself could affect both literal infringement and validity.

How broad is independent claim 1?

Claim 1 is a broad apparatus claim with no limitation to:

• testosterone;
• a particular container volume;
• a particular needle gauge;
• a particular spring material;
• a specific injection route;
• a specific housing shape;
• a specific dose;
• a particular drug concentration; or
• a specific pressure or velocity.

The claim requires a medicament container and a ram that pressurizes that container. It does not expressly require a needle, although dependent claims add one. A needle-free injector could potentially fall within claim 1 if it otherwise satisfies the ram, trigger, end-cap, and release limitations.

The key infringement issue is structural identity. The claim is less likely to reach a conventional syringe with a manually depressed plunger because such a product may lack:

1. a floating trigger member;
2. a floating trigger engagement member on the ram assembly;
3. an end-cap ram holding member; and
4. the claimed pre-firing retention and release sequence.

What do claims 2 through 9 protect?

Claims 2-9 add automatic skin-contact activation and needle-assisted delivery.

Skin-contact firing and needle guard

Claim 2 requires a skin-contacting firing member at the distal end of the injector. Proximal movement of that member against the housing initiates firing. Claim 3 specifies a retractable needle guard that exposes the needle as the distal member moves proximally.

This creates a two-function interface:

• the user presses the injector against the skin;
• the same proximal movement exposes the needle and initiates firing.

A product that requires a separate push button after needle insertion may avoid the literal scope of claims 2 and 3, although it could remain within claim 1 if the floating-trigger architecture is present.

Claim 4 requires fluid communication between the needle and medicament container. Claims 5-7 add performance and delivery limitations:

• pressure of approximately 90 to 500 psi;
• average velocity of at least approximately 1,000 cm/sec within the needle; and
• jet injection through the needle.

Claims 5 and 6 are narrower because they introduce measurable operating parameters. Enforcement would likely require technical testing, design records, or admissions concerning pressure and velocity. “About” creates a range-of-equivalents issue, while the numerical limitations may create prosecution-history estoppel if the applicant relied on those ranges to distinguish prior art.

Cam and engagement-surface alternatives

Claims 8 and 9 define alternative mechanisms for moving the floating trigger:

• claim 8 requires a first cam on the skin-contacting member and a second cam on the floating trigger, producing axial rotation;
• claim 9 requires first and second engagement surfaces that cause trigger movement.

These claims provide fallback positions if claim 1 is challenged. Claim 8 is more structurally specific than claim 9. A non-rotating trigger mechanism may avoid claim 8 but still face claim 9 or claim 1 depending on the interaction between the trigger and firing member.

What do claims 10 through 16 protect?

These claims address manufacturing, safety, lockout, and status indication.

Claims	Subject matter	Commercial function
10	Unitary ram assembly	Reduces component count and assembly complexity
11	Projection with bulge and groove engaged with the trigger engagement member	Defines the mechanical retention geometry
12	Container support and post-injection lockout	Prevents reuse or repeat firing
13	Ram blocks further proximal movement of firing member	Provides mechanical confirmation of lockout
14	Visible fired-state indicator through a housing window	Gives the user a status signal
15	Indicator incorporated into the ram assembly	Couples status indication to ram movement
16	Ram assembly entirely occludes the window in the fired condition	Defines a particular visual-transition architecture

Claims 12 and 13 are relevant to single-use autoinjector design. A device that cannot be fired again may still avoid these claims if it uses an electronic lockout, a separate shield, or a different blocking structure.

Claims 14-16 are likely easier to design around than claim 1 because visual indication can be implemented through a colored flag, plunger position, window shutter, electronic indicator, or transparent housing. The strongest limitation is the requirement that the indicator color be absent from the pre-firing color gamut and become visible through the housing window after firing.

What do claims 17 through 20 protect?

Claims 17-20 narrow the injector to androgen delivery:

• claim 17: an androgen;
• claim 18: testosterone or a derivative or ester;
• claim 19: testosterone cypionate;
• claim 20: testosterone enanthate.

These are not composition-of-matter claims. They do not claim testosterone enanthate or testosterone cypionate independently of the injector. They claim an injector having the previously recited device features and containing or delivering the specified androgen.

The commercial significance is strongest for testosterone enanthate autoinjectors. A product could avoid claims 19-20 by using a different testosterone ester, but that would not avoid claims 1-16 if the same mechanical injector were used.

The claims do not cover:

• oral testosterone;
• testosterone gels;
• conventional testosterone vials used with separate syringes;
• testosterone compounds without the claimed injector architecture; or
• an injector that lacks the claimed trigger and ram relationship.

When does U.S. Patent 10,357,609 lose exclusivity?

The patent issued on July 23, 2019. The statutory expiration date cannot be established from the issue date alone. It depends on the earliest effective nonprovisional filing date, any terminal disclaimer, patent term adjustment, and any patent term extension. Patent term generally runs 20 years from the earliest effective nonprovisional filing date under 35 U.S.C. §154, subject to those adjustments (U.S. Patent and Trademark Office, n.d.-a).

For commercial planning, the relevant dates are:

Event	Date or rule
Patent issue	July 23, 2019
Ordinary patent term	20 years from the applicable earliest nonprovisional filing date
Patent term adjustment	May extend the term for qualifying USPTO delays
Terminal disclaimer	May limit expiration to an earlier related patent
Patent term extension	Potentially available for qualifying regulatory delay, but not assumed
Post-expiration use	Patent claims cease to block conduct after expiration, subject to other unexpired patents

The issued patent’s expiration should be confirmed through USPTO Patent Center and the patent’s official term data before relying on a particular launch date. A patent’s expiration date is separate from FDA regulatory exclusivity.

What is the Orange Book status of U.S. Patent 10,357,609?

The claims alone do not establish whether Patent 10,357,609 is listed in the FDA Orange Book. Orange Book listing is a regulatory submission and publication issue, not a consequence of patent issuance.

For a drug-device combination such as testosterone enanthate in a prefilled autoinjector, Orange Book relevance depends on whether the patent claims the approved drug, its formulation, or an approved method of use. A pure device patent may not qualify for listing in the same manner as a drug-substance, drug-product, or method-of-use patent.

The FDA Orange Book should be reviewed for:

• the specific testosterone enanthate product;
• listed patent numbers;
• patent-use codes;
• delisting or expiration entries; and
• any 30-month stay associated with an ANDA Paragraph IV notice (FDA, n.d.-a).

An ANDA applicant would have to address listed patents through a Paragraph I, II, III, or IV certification. If the patent is not listed for the relevant reference product, it generally would not create an Orange Book-based Paragraph IV barrier, although the patent holder could still pursue infringement under other statutory routes if the product practices the claims.

What Paragraph IV challenges and generic entry risks exist?

A generic testosterone enanthate applicant faces two separate issues:

1. approval of the drug product under section 505(j); and
2. freedom to market the delivery device.

A conventional vial-and-syringe generic may have lower risk under this patent because it would not ordinarily contain the claimed injector architecture. A prefilled autoinjector or needle-assisted jet injector would face higher risk if it includes:

• a spring-powered ram;
• a floating trigger;
• a ram-mounted engagement member;
• an end-cap retaining structure; and
• automatic release through skin-contact movement.

A Paragraph IV challenge would likely target one or more of the following:

• anticipation by an earlier autoinjector or jet-injector reference;
• obviousness based on combining known trigger, ram, and lockout structures;
• indefiniteness of “floating,” “about,” “pre-firing condition,” or the engagement language;
• lack of written description for the full combination;
• enablement of the pressure, velocity, and androgen embodiments; and
• claim construction based on prosecution amendments or disclaimers.

Claims 5 and 6 may be vulnerable to enablement or indefiniteness attacks if the specification does not provide sufficient measurement methodology or operating examples. Claim 1 may be more resilient if the specification describes several floating-trigger embodiments and multiple energy sources.

Which companies are challenging the patent?

The supplied claim text does not identify a filed Paragraph IV notice, ANDA applicant, district-court action, International Trade Commission investigation, or settlement involving Patent 10,357,609. A patent number alone does not establish that a company is challenging it.

Public litigation searches should distinguish among:

• a Hatch-Waxman action under 21 U.S.C. §355(j);
• a declaratory-judgment action;
• a patent-infringement action involving an autoinjector manufacturer;
• an inter partes review at the Patent Trial and Appeal Board; and
• a contractual dispute involving a license or supply agreement.

A regulatory challenge and a patent-litigation challenge are separate events. The FDA Orange Book identifies listed patents, while PACER, PTAB records, and court dockets identify litigation or validity proceedings.

How strong is the patent estate?

Strengths

The estate has several commercially useful characteristics:

• Claim 1 combines multiple mechanical relationships that may be difficult to avoid without redesign.
• The claim covers the injector architecture independently of androgen use.
• Claims 2-9 capture automatic skin-contact firing and needle-assisted delivery.
• Claims 12-16 address single-use lockout and visual confirmation, which are common commercial requirements.
• Claims 17-20 tie the device to testosterone products, including testosterone enanthate.

Weaknesses

The principal vulnerabilities are:

• functional language concerning release and energy-source operation;
• potential ambiguity concerning what is disengaged from the retaining portion;
• possible prior art covering spring-driven autoinjectors and floating triggers;
• numerical limitations that may be difficult to prove consistently;
• limited value of the androgen claims against products using conventional syringes; and
• possible lack of Orange Book leverage if the patent is treated as a device-only patent.

The practical strength is therefore highest against a product that copies the trigger-and-ram mechanism. It is lower against a generic testosterone product delivered through a vial, syringe, cartridge, or materially different autoinjector.

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

Patent 10,357,609 is primarily a device patent.

Patent category	Protects	Relevance to this patent
Device patent	Injector structure and operation	Core subject of Patent 10,357,609
Formulation patent	Concentration, excipients, stability, container compatibility	Not expressly claimed in the supplied claims
Composition patent	Testosterone molecule, ester, or derivative	Not claimed
Method-of-use patent	Treating a defined patient population or condition	Not claimed as a treatment method
Manufacturing patent	Filling, assembly, sterilization, or cartridge production	Not claimed in the supplied claims
Regulatory exclusivity	FDA-approved product or indication	Separate from patent rights

A generic manufacturer can avoid this patent while still needing to address separate formulation, container-closure, manufacturing, or method-of-use patents. Conversely, designing around this injector patent does not eliminate risk from product-specific patents.

What manufacturing and geographic barriers apply?

The patent’s principal manufacturing barrier is replication of the mechanical release system. High-risk design areas include:

• the floating trigger geometry;
• the ram engagement member;
• the end-cap projection, bulge, and groove;
• the spring or other energy source;
• the container support lockout;
• the firing-state indicator; and
• the relationship between the needle guard and firing member.

A manufacturer can reduce risk through a different firing architecture, such as:

• a rigid trigger rather than a floating trigger;
• a separate release button;
• a rotary latch located outside the ram assembly;
• a non-axial ram restraint;
• a hydraulic or gas-driven mechanism with a different engagement structure; or
• a reusable electronic or electromechanical actuator.

U.S. patent rights do not automatically block manufacture or sale outside the United States. Territorial risk must be assessed separately for each jurisdiction, including foreign counterparts, national-phase filings, continuations, and divisionals. U.S. importation of an infringing injector can create U.S. exposure even when manufacture occurs abroad under 35 U.S.C. §271.

What licensing deals affect the patent?

No licensing or assignment transaction can be inferred from the claim language. Ownership and license rights must be verified through USPTO assignment records, corporate disclosures, SEC filings, product agreements, and litigation settlements.

The relevant commercial documents are:

• assignment records for Patent 10,357,609;
• exclusive or nonexclusive device licenses;
• manufacturing and supply agreements;
• development agreements for testosterone autoinjectors;
• settlement agreements resolving Paragraph IV or device litigation; and
• covenants not to sue.

A product supplier may hold rights under a license even if the patent owner is not the marketed product’s labeler. Conversely, a distribution agreement does not necessarily provide patent rights.

What generic launch scenarios are most likely?

Launch scenario	Patent risk under 10,357,609	Commercial assessment
Testosterone enanthate vial and syringe	Low to moderate	Likely avoids the injector-specific limitations
Prefilled syringe without automatic firing	Low to moderate	Depends on whether the trigger and ram elements exist
Conventional spring autoinjector with fixed trigger	Moderate	May avoid “floating” trigger limitations
Skin-activated autoinjector with copied ram latch	High	Closely tracks claims 1-4 and potentially 8-13
Needle-assisted jet injector	High	Potentially implicates claims 1-9
Same device delivering testosterone cypionate	High for claims 1-16; lower for claim 19	Device claims remain independent of androgen limitations
Same device delivering testosterone enanthate	Highest	Potentially implicates claims 1-20
Device with redesigned firing mechanism and same drug	Lower under this patent	Other formulation or product patents may remain relevant

Key Takeaways

• Patent 10,357,609 is an injector-mechanism patent, not a testosterone composition patent.
• Claim 1 is the principal broad claim and requires a floating trigger, ram assembly, energy source, and end-cap ram-holding interaction.
• Claims 2-9 target skin-activated, needle-assisted, and jet-injection embodiments.
• Claims 12-16 protect lockout and visual fired-state indication features.
• Claims 17-20 narrow the invention to androgen delivery, including testosterone cypionate and testosterone enanthate.
• A conventional testosterone generic may avoid the patent through a vial, syringe, or materially different injector.
• A copied prefilled autoinjector presents materially higher infringement risk.
• Orange Book listing, Paragraph IV activity, litigation, settlement, licensing, and current enforceability cannot be established from the claim text alone.
• Final launch analysis requires review of the patent’s complete family, prosecution history, term data, assignments, FDA listings, and court and PTAB records.

References

1. U.S. Patent No. 10,357,609, claims 1-20. United States Patent and Trademark Office. (2019).
2. U.S. Patent and Trademark Office. (n.d.-a). Patent term adjustment and patent term information. https://www.uspto.gov/patents/laws/patent-term-adjustment
3. U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
4. U.S. Food and Drug Administration. (n.d.-b). Generic drug user fee amendments and abbreviated new drug applications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
5. U.S. Code, 35 U.S.C. §§ 154, 271.
6. U.S. Code, 21 U.S.C. § 355(j).

Drugs Protected by US Patent 10,357,609

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 10,357,609

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013203784
Canada	2868500
Canada	2900672
China	104487114