Details for Patent: 10,821,072

Which drugs does patent 10,821,072 protect, and when does it expire?

Patent 10,821,072 protects XYOSTED (AUTOINJECTOR) and is included in one NDA.

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

Summary for Patent: 10,821,072

Title:	Needle assisted jet injection administration of testosterone compositions
Abstract:	The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
Inventor(s):	Paul K. WOTTON, Kaushik J. Dave, John W. Hayes, Peter L. Sadowski, Hermanus L. Jooste, Jonathan Jaffe
Assignee:	Antares Pharma Inc
Application Number:	US16/149,032
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Drug Patent 10,821,072: Claim Scope, Xyosted Coverage, Expiration Risk, and Patent Landscape

U.S. Patent No. 10,821,072 protects a testosterone-administration method that combines four elements: a preservative-free subcutaneous testosterone composition, a powered injector, defined plasma testosterone exposure, and specified injection-count, duration, concentration, liquid, dose, and precipitation limitations. The claims are method claims rather than composition, device, or manufacturing claims. The principal commercial relevance is testosterone enanthate delivered by a powered autoinjector, including the Xyosted product platform associated with Antares Pharma.

The claim set is narrower than a general patent on subcutaneous testosterone. A competing product must satisfy every limitation of an asserted claim, but infringement risk increases where the product uses a preservative-free liquid testosterone formulation in a powered injector and the prescribing information or clinical instructions establish sustained testosterone levels within the claimed ranges.

What does U.S. Patent 10,821,072 protect?

The patent protects a method of administering testosterone to a mammal through a powered injector. Independent claim 1 requires:

Required element	Scope
Active ingredient	Testosterone, a pharmaceutically acceptable ester, or a pharmaceutically acceptable salt
Route	Subcutaneous administration
Formulation	Preservative-free composition in a pharmaceutically acceptable carrier
Dose structure	A unit dose
Delivery system	At least one injection through a powered injector
Injector structure	Housing, internal chamber, and needle operatively associated with the chamber
Pharmacokinetic result	Plasma testosterone remains above about 200 ng/dL for a predetermined period

The claim does not expressly require testosterone enanthate, a particular concentration, a particular injection volume, a particular needle gauge, a specific injector energy source, or a particular treatment indication. It also does not expressly require weekly administration.

The claim is a result-limited method claim. A product or treatment may fall within its scope even if the formulation, dose, or injector differs from the commercial product, provided the claimed administration process and plasma result are present.

What is the importance of the powered-injector limitation?

The powered-injector requirement is a material narrowing limitation. A conventional manual syringe, ordinary needle, or non-powered injection device would not satisfy the limitation unless the device nevertheless falls within the proper construction of "powered injector."

The structural language requires:

1. A housing.
2. A chamber within the housing that receives the testosterone composition.
3. A needle associated with the chamber.
4. A powered mechanism used for the injection.

The claim does not expressly limit the power source to a spring, gas, motor, or other mechanism. This creates potential breadth across disposable autoinjectors, cartridge-based systems, and other mechanically or electronically powered delivery devices.

A formulation administered manually could avoid claim 1 if the powered-injector limitation is absent. Conversely, a powered injector carrying a preserved testosterone formulation could avoid the claim because "preservative-free" is also required.

How do claims 2 through 20 modify claim 1?

Claims 2 through 20 are dependent claims. Each incorporates every limitation of claim 1 and adds a further condition.

Claims	Added limitation	Commercial significance
2	The administration consists of two injections	Covers split-dose protocols
3	The administration consists of three injections	Covers three-injection protocols
4	The administration consists of more than three injections	Covers multi-injection regimens
5	Plasma level remains above selected thresholds from about 300 to 1,100 ng/dL	Creates multiple exposure-based fallback positions
6	Plasma level remains above the threshold for at least one hour	Short-duration exposure claim
7	At least 12 hours	Same-day exposure
8	At least one day	Daily exposure
9	At least six days	Nearly weekly duration
10	At least seven days	Weekly or longer duration
11	At least nine days	Extended weekly coverage
12	At least 11 days	Approximately 11-day coverage
13	At least 13 days	Approximately two-week coverage
14	At least 15 days	More than two-week coverage
15	At least 20 days	Long-interval dosing
16	At least 25 days	Approximately monthly coverage
17	The composition is liquid	Relevant to injectable drug products
18	A single unit dose is administered	Limits the method to one-dose administration
19	Plasma testosterone does not exceed about 1,800 ng/dL	Adds an upper exposure ceiling
20	The composition is substantially free of precipitate	Targets physical stability and injectability

Claims 5 through 16 create a matrix of lower plasma thresholds and time periods. They are not independent claims. A product must first satisfy claim 1 before any dependent claim can be infringed.

What are the principal claim-construction issues?

What does "preservative-free" mean?

"Preservative-free" is likely to be central in litigation. The term can distinguish the claimed formulation from testosterone injections containing antimicrobial preservatives, such as benzyl alcohol or related excipients. The scope may turn on whether trace contaminants, manufacturing residues, or excipients with incidental antimicrobial activity defeat the limitation.

A formulation with no intentionally added preservative presents the strongest literal-infringement position. A formulation containing an antimicrobial excipient creates a potential noninfringement argument, subject to the patent specification and prosecution history.

What does "about" mean for plasma testosterone?

The claims use "about" before the numerical concentrations. Courts generally interpret "about" in light of the specification, technical practice, measurement variability, and prosecution history. The relevant question is not whether a measured concentration is exactly 200, 300, or 1,100 ng/dL. The question is whether the measured value falls within the legally applicable tolerance around the claimed value.

Testing methodology matters. Total testosterone, free testosterone, sampling time, assay platform, patient population, and pharmacokinetic variability can affect infringement analysis.

What does "predetermined period of time" require?

The period must be defined before or as part of the administration protocol. Claims 6 through 16 provide express minimum durations. Claim 1 is broader in wording but still requires that testosterone remain above about 200 ng/dL for a predetermined period.

A single post-dose measurement would generally be insufficient to establish sustained exposure. Clinical pharmacokinetic data, label instructions, dosing protocols, and patient-level or population-level measurements would be relevant.

What does "substantially free of precipitate" add?

Claim 20 is a physical-state limitation. It may cover compositions that contain no visible or clinically relevant precipitate while allowing minor particulate matter below an applicable threshold. The specification and analytical methods would control the precise boundary.

This claim is potentially useful against formulations that are chemically equivalent but differ in physical stability, suspension behavior, or storage performance.

How strong is the patent estate represented by U.S. Patent 10,821,072?

The patent has meaningful commercial value because it combines formulation, delivery device, administration route, and pharmacokinetic performance in one method. That combination can make design-around more difficult than a patent directed only to testosterone chemistry.

Its strength is reduced by the number of limitations in claim 1:

• The composition must be preservative-free.
• Administration must be subcutaneous.
• The dose must be delivered through a powered injector.
• The testosterone level must remain above a specified threshold.
• The claim requires a defined plasma outcome.
• The formulation must contain testosterone or an eligible ester or salt.

The claim does not cover every testosterone replacement product. Intramuscular testosterone cypionate, intramuscular testosterone enanthate, oral testosterone undecanoate, transdermal testosterone, buccal testosterone, and manual syringe injections generally fall outside claim 1 because they lack the required combination of route and powered delivery.

The strongest infringement scenario is a product that replicates the following commercial configuration:

• Testosterone enanthate or another testosterone ester.
• Preservative-free liquid formulation.
• Subcutaneous delivery.
• Single-dose or split-dose autoinjector.
• Sustained testosterone levels at or above the claimed threshold.
• A dosing interval of approximately one week or longer.

What patent landscape surrounds testosterone autoinjectors?

The relevant landscape includes four patent categories.

What formulation patents protect testosterone injections?

Formulation patents may claim:

• Testosterone enanthate concentration.
• Oil or aqueous carrier systems.
• Solubilizers and co-solvents.
• Viscosity control.
• Preservative-free compositions.
• Stability during storage.
• Reduced precipitation.
• Injection volume and tolerability.

A formulation patent can create infringement exposure even where a competitor uses a different injector. Patent 10,821,072 does not itself claim a standalone composition, so it should be analyzed with related family patents and third-party formulation patents.

What method-of-use patents protect testosterone replacement therapy?

Method-of-use patents can cover:

• Subcutaneous testosterone administration.
• Weekly or extended-interval dosing.
• Achievement of specified testosterone levels.
• Avoidance of supraphysiologic concentrations.
• Treatment of male hypogonadism.
• Dose titration based on serum testosterone.
• Administration through an autoinjector.

Patent 10,821,072 is principally in this category, although it incorporates formulation and device limitations.

What device patents affect powered testosterone delivery?

Device patents may claim:

• Autoinjector architecture.
• Cartridge and chamber arrangements.
• Needle deployment.
• Drive mechanisms.
• Injection speed.
• Dose delivery control.
• Safety interlocks.
• Prefilled injector configurations.

A competitor may avoid the drug patent while still requiring a license to the injector technology. Conversely, a licensed or internally developed injector does not eliminate exposure to the method claims.

What manufacturing and IP barriers exist?

Manufacturing barriers may arise from:

• Sterile filling of an oil-based or otherwise viscous testosterone formulation.
• Maintaining a preservative-free product during shelf life.
• Preventing precipitation or phase separation.
• Achieving reproducible dose delivery through a powered injector.
• Controlling injection force and duration.
• Validating container-closure integrity.
• Demonstrating device-drug compatibility.

These technical barriers are not all claimed by Patent 10,821,072, but they can increase the practical cost of designing around the patent estate.

What is the Orange Book status of Patent 10,821,072?

Patent 10,821,072 is associated with the subcutaneous testosterone enanthate product Xyosted and the Antares Pharma testosterone replacement platform. Xyosted received FDA approval in 2018 for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. The product is administered subcutaneously using a single-dose autoinjector.[2]

The Orange Book analysis must distinguish three matters:

1. Whether the patent is listed against Xyosted.
2. The applicable use code and labeled indication.
3. Whether the patent remains enforceable after any terminal disclaimer, patent-term adjustment, or other term event.

An Orange Book listing does not establish validity or infringement. It gives the reference-listed drug sponsor a basis to receive a Paragraph IV notice and potentially file Hatch-Waxman litigation.

Patent 10,821,072 is a method patent, so its practical Orange Book value depends on whether the claimed method corresponds to an approved use and whether the listing satisfies FDA listing requirements. The patent number, approved product, use code, and current listed expiration should be confirmed against the current FDA Orange Book and the patent's USPTO maintenance and term records.[3]

When does U.S. Patent 10,821,072 lose exclusivity?

The patent issued on November 3, 2020. Its statutory term is generally measured from the earliest effective nonprovisional filing date for the claimed subject matter, not from the issue date. The actual expiration date can be affected by:

• Patent-term adjustment.
• Patent-term extension.
• Terminal disclaimer.
• Continuation or divisional priority rules.
• Disclaimer or lapse for failure to pay maintenance fees.
• Post-grant cancellation or narrowing of claims.

The issue date alone does not establish the expiration date. The enforceable term must be determined from the patent's continuity data, term calculation, and USPTO records.[1] FDA regulatory exclusivity is separate from patent exclusivity. Xyosted's original FDA approval provided regulatory exclusivity in addition to any patent rights, but that period does not automatically extend the patent term.

Which companies are challenging testosterone autoinjector exclusivity?

The principal competitive threat is expected from generic testosterone manufacturers rather than biosimilar developers. Testosterone is a small-molecule active ingredient. A competing manufacturer would generally use the abbreviated new drug application pathway under section 505(j), not the biosimilar pathway under section 351(k).

Potential challengers include companies developing:

• Generic testosterone enanthate injections.
• Alternative subcutaneous testosterone products.
• Intramuscular testosterone products.
• Oral testosterone products.
• Transdermal testosterone products.
• Autoinjector-based testosterone replacement products.

A generic product can launch without practicing every patented method if it uses a different route, device, formulation, or labeled indication. A Paragraph IV certification against an Orange Book-listed patent can trigger litigation under 21 U.S.C. § 355(j)(5)(B)(iii), with a potential 30-month stay of FDA approval under applicable conditions.[4]

No biosimilar risk applies to testosterone itself. Device-related competition can still create regulatory and patent risk if the delivery system is supplied as part of the drug product.

What generic launch scenarios exist for Xyosted?

Scenario	Likely patent exposure	Commercial effect
Generic intramuscular testosterone enanthate	Usually avoids the subcutaneous powered-injector claim	Direct price competition, but not a full device substitute
Generic subcutaneous testosterone using a manual syringe	Potentially avoids claim 1	Competes on route but not on delivery system
Preserved subcutaneous testosterone in a powered injector	Potentially avoids the preservative-free limitation	Requires separate formulation and device analysis
Preservative-free testosterone in a non-powered injector	Potentially avoids the powered-injector limitation	Lower device complexity
Preservative-free testosterone in a powered injector with shorter exposure	Possible challenge to pharmacokinetic limitations	Requires robust clinical and pharmacokinetic evidence
Product labeled for a different use	May reduce method-of-use exposure	Regulatory labeling strategy becomes material
Full Xyosted-style substitute	Highest exposure to the patent estate	Most direct commercial competition

A carve-out label may reduce method-of-use exposure, but it cannot eliminate infringement where the approved label, product instructions, device design, or actual marketing encourage the patented administration method.

What litigation and settlement issues should be monitored?

The relevant litigation questions are:

• Whether the patent has been asserted against an ANDA applicant.
• Whether a Paragraph IV notice has been served.
• Whether a 30-month stay has been triggered.
• Whether claims have survived validity challenges.
• Whether the parties entered a licensed or restricted launch settlement.
• Whether a settlement includes an authorized generic, supply agreement, or launch date.
• Whether the patent has been subject to inter partes review or other post-grant proceedings.
• Whether a terminal disclaimer links its expiration to another patent.

A settlement may permit an earlier generic launch without eliminating the patent. The commercial outcome depends on the negotiated launch date, restrictions, authorized-generic terms, and remaining Orange Book patents.

How does Patent 10,821,072 compare with competing testosterone products?

Product category	Route	Powered injector	Preservative-free requirement	Exposure to Patent 10,821,072
Xyosted	Subcutaneous	Yes	Yes	Highest
Intramuscular testosterone enanthate	Intramuscular	Usually no	Product-specific	Generally lower
Intramuscular testosterone cypionate	Intramuscular	No	Product-specific	Generally lower
Oral testosterone undecanoate	Oral	No	Not applicable	Low
Transdermal gel or patch	Transdermal	No	Not applicable	Low
Manual subcutaneous injection	Subcutaneous	No	Product-specific	Potentially avoids claim 1
Competing powered subcutaneous injection	Subcutaneous	Yes	Product-specific	Requires full limitation-by-limitation analysis

The patent is most relevant to products attempting to reproduce the convenience and pharmacokinetic profile of a subcutaneous testosterone autoinjector. It is less important to conventional testosterone replacement products that use different routes or devices.

What is the revenue exposure from this patent?

The patent's revenue exposure is concentrated in the branded subcutaneous autoinjector market rather than the broader testosterone market. A successful generic equivalent could pressure:

• Net sales of the reference-listed product.
• Price and rebate levels.
• Payer formulary position.
• Prescriber adoption.
• Patient persistence associated with autoinjector convenience.
• Licensing value of the related formulation and device portfolio.

A generic intramuscular product may reduce price pressure without fully replacing the branded autoinjector. A product with the same route, dose convenience, and device format would pose the greatest substitution risk.

Key Takeaways

• U.S. Patent 10,821,072 is a method patent covering preservative-free subcutaneous testosterone delivered through a powered injector.
• Claim 1 requires both a device limitation and a pharmacokinetic result.
• The patent does not broadly cover all testosterone replacement products.
• Claims 2 through 20 add injection-count, plasma-level, duration, liquid, single-dose, upper-exposure, and precipitation limitations.
• The strongest risk concerns a Xyosted-like testosterone autoinjector using a preservative-free formulation.
• A manual syringe, intramuscular product, oral product, transdermal product, or preserved formulation may avoid one or more claim limitations.
• Testosterone is a small molecule, so generic competition proceeds through the ANDA pathway rather than the biosimilar pathway.
• Orange Book listing, current term, litigation, and settlement status must be evaluated separately from claim validity.
• The patent's issue date is November 3, 2020; the expiration date cannot be determined from the claims alone and depends on continuity, term adjustment, extension, and disclaimer records.
• The patent's commercial strength lies in the combination of route, formulation, injector, and sustained testosterone exposure limitations.

Frequently Asked Questions

Does Patent 10,821,072 cover testosterone cypionate?

Not automatically. Testosterone cypionate could satisfy the active-ingredient limitation, but the product would also need to meet the subcutaneous, preservative-free, powered-injector, unit-dose, and plasma-exposure limitations.

Can a generic avoid Patent 10,821,072 by using a manual syringe?

A manual syringe may avoid the powered-injector limitation. The complete product, labeling, administration instructions, and actual use would still require a full infringement analysis.

Does the patent cover a testosterone formulation with benzyl alcohol?

A formulation intentionally containing benzyl alcohol would present a potential defense to the "preservative-free" limitation. The result would depend on the formulation, claim construction, and prosecution history.

Is a biosimilar application relevant to testosterone?

No. Testosterone is a chemically defined small molecule. Generic testosterone products generally use the ANDA pathway under section 505(j), not the biosimilar pathway under section 351(k).

Can FDA approval proceed while Patent 10,821,072 remains in force?

Yes, FDA approval and patent enforceability are separate issues. An ANDA applicant may challenge the patent, wait for expiration, obtain a settlement-based launch date, or pursue a product design that does not practice the asserted claims.

References

1. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,821,072, methods of administering testosterone. https://patents.google.com/patent/US10821072B2/en

2. U.S. Food and Drug Administration. (2018). Xyosted prescribing information. https://www.accessdata.fda.gov

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

4. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).

Drugs Protected by US Patent 10,821,072

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			METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes			Y			METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y			METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY

International Family Members for US Patent 10,821,072

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013203784
Canada	2868500
Canada	2900672
China	104487114
Denmark	2953667
Denmark	3659647
European Patent Office	2731645