United States Drug Patent 11,304,960: Claim Scope, Validity Risks, and Testosterone Undecanoate Patent Landscape

U.S. Patent No. 11,304,960 protects a solid or semisolid oral testosterone undecanoate formulation containing approximately 15% testosterone undecanoate, 50% to 70% glyceryl monolinoleate-based lipophilic carrier, 10% to 20% polyoxyl 40 hydrogenated castor oil, and a solidifying agent. The independent commercial value lies in the excipient architecture, not testosterone undecanoate itself.

Claim 1 is a composition claim with potentially meaningful blocking power against products using the same lipid-surfactant system. Claim 2 adds a steady-state testosterone concentration requirement and twice-daily administration with food. That limitation may narrow infringement exposure but creates added validity and proof issues because the claim does not specify dose, treatment duration, sampling protocol, assay method, or the exact composition of the patient population.

The patent’s principal risks are claim-construction disputes over the lipophilic carrier, numerical ranges, the term “about,” and the relationship between the excipient percentages and the solidifying agent. Its competitive significance depends on whether a marketed or pipeline oral testosterone product uses glyceryl monolinoleate and polyoxyl 40 hydrogenated castor oil within the claimed ranges.

What does U.S. Patent 11,304,960 protect?

The patent protects a defined oral delivery system for testosterone undecanoate in a jelly, solid, semisolid, or paste-like dosage form.

Claim 1 element-by-element analysis

Claim element	Scope	Commercial significance
Oral pharmaceutical composition	Covers a drug product intended for oral administration	Excludes injectable, transdermal, buccal, and non-oral products
Testosterone undecanoate	The active pharmaceutical ingredient must be TU	Does not broadly cover other testosterone esters
About 15% w/w TU	Approximate concentration limitation	Products materially above or below the range may avoid literal infringement
Lipophilic carrier comprising glyceryl monolinoleate	Requires GML as a component of the lipophilic carrier	The “comprising” language permits additional carrier ingredients
Carrier at 50% to 70% w/w	Quantitative carrier limitation	Creates a formulation fingerprint that can be designed around
Polyoxyl 40 hydrogenated castor oil at 10% to 20% w/w	Requires a specified nonionic surfactant in a defined range	A second quantitative limitation that may narrow the patent’s practical reach
Solidifying agent	Requires a material that converts or maintains the formulation as a solid or semisolid	The patent does not appear, from the supplied claim, to restrict the solidifying agent to a named substance
Jelly, solid, semisolid, or paste-like	Defines the dosage-form state	Broad enough to cover several non-liquid product formats

The claim uses “comprising” for the overall composition and for the lipophilic carrier. That is important. A competing product can contain additional oils, surfactants, stabilizers, antioxidants, or excipients and still fall within the claim if all required elements are present.

The claim does not, on its face, require:

A specific capsule shell;
A particular unit dose of testosterone undecanoate;
A named solidifying agent;
A defined ratio of glyceryl monolinoleate to other lipid ingredients;
A particular particle size;
A specific manufacturing process;
A particular fed-state pharmacokinetic profile; or
A specified testosterone undecanoate release rate.

The numerical formulation limits

The claimed formulation includes:

Testosterone undecanoate: about 15% w/w;
Lipophilic carrier: 50% to 70% w/w; and
Polyoxyl 40 hydrogenated castor oil: 10% to 20% w/w.

Those values consume approximately 75% to 105% of the total composition before accounting for the solidifying agent and any other excipients. The upper-end combination therefore raises a claim-construction issue. The carrier may include the surfactant, meaning that polyoxyl 40 hydrogenated castor oil may be counted within the 50% to 70% carrier fraction. If the surfactant is separate from the carrier, some combinations are mathematically impossible.

That issue could affect infringement analysis and validity. A court would likely examine the specification, examples, ingredient definitions, and whether the claim permits overlapping component categories. The patent owner would likely argue that the carrier is a composition-level category that can include the surfactant. A challenger could argue that the claim is indefinite or lacks an enabling disclosure for the full numerical scope if the ranges cannot be reconciled.

How strong is the patent estate for U.S. Patent 11,304,960?

The individual claim is technically narrow but potentially commercially important. Its strength is best characterized as moderate to strong against close formulation copies and weaker against products using a different lipid system.

Strengths

Multiple required formulation elements.
A challenger must avoid or contest testosterone undecanoate, glyceryl monolinoleate, the carrier range, polyoxyl 40 hydrogenated castor oil, and the solid or semisolid dosage form.
Composition-claim structure.
Claim 1 does not require proof that a patient achieved a particular testosterone level. A product can infringe based on its composition alone.
Open-ended “comprising” language.
Additional excipients do not automatically avoid infringement.
Potential coverage of several physical formats.
Jelly, solid, semisolid, and paste-like products may include soft formulations, molded units, chewable matrices, and other non-liquid systems depending on the specification’s definitions.

Weaknesses

Dependence on exact excipient identity.
Replacing glyceryl monolinoleate with another monoacylglycerol, medium-chain glyceride, oleic-acid system, or unrelated lipid may avoid literal infringement.
Numerical-range design-around potential.
A product using polyoxyl 40 hydrogenated castor oil at 9% or 21%, or a carrier outside 50% to 70%, may create a noninfringement position subject to “about,” prosecution history, and equivalents analysis.
Potential percentage ambiguity.
The carrier and surfactant categories may overlap, creating an issue over whether the percentages are calculated independently or hierarchically.
Limited information in claim 1 concerning performance.
The claim does not require a particular bioavailability result. A formulation that falls within the composition limits may be covered even if its pharmacokinetics differ, subject to enablement and written-description defenses.
Claim 2’s pharmacokinetic uncertainty.
The plasma testosterone range is broad, and the claim does not identify the dose, duration, sampling point, assay, or whether the concentration is total or free testosterone.

What does claim 2 add to the patent?

Claim 2 depends on claim 1 and requires that the composition provide a plasma testosterone concentration of approximately 250 ng/dL to 1,200 ng/dL at steady state when administered orally, once or in multiple unit dosage forms, twice daily with a meal to a hypogonadal male.

The additional limitations are:

Administration to a hypogonadal male;
Twice-daily dosing;
Administration with a meal;
Steady-state pharmacokinetics; and
Plasma testosterone concentration of approximately 250 ng/dL to 1,200 ng/dL.

Claim 2 is narrower than claim 1, but its practical interpretation is complicated.

Product claim or method limitation?

Because claim 2 is written as a dependent composition claim, the patent owner may argue that it protects a composition having the stated functional capability. An accused infringer may argue that the pharmacokinetic language is a method-of-use limitation that cannot be established solely by chemical analysis of the product.

For a commercial product, the patent owner would likely rely on:

Clinical pharmacokinetic data;
FDA-submitted formulation and dose information;
Label instructions requiring administration with food;
Bioequivalence or comparative exposure studies; and
Testing of testosterone concentrations at steady state.

A competitor could argue that patient-specific pharmacokinetics vary too widely for the concentration range to define a reliable structural property. The absence of a specified dose and sampling protocol increases that dispute.

What formulation patents are relevant to oral testosterone undecanoate?

The relevant patent landscape divides into four groups:

Patent category	Typical protected subject matter	Relevance to U.S. 11,304,960
Lipid formulation patents	TU combined with oils, lipids, surfactants, and self-emulsifying systems	Highest overlap risk
Solid or semisolid dosage-form patents	Jellies, pastes, molded units, soft solids, and solidified lipid systems	Directly relevant to claim 1
Pharmacokinetic and dosing patents	Twice-daily dosing, administration with food, testosterone target ranges	Relevant to claim 2
Manufacturing patents	Mixing, heating, cooling, solidification, filling, and encapsulation	Can create separate process barriers

The active ingredient itself, testosterone undecanoate, is an established testosterone ester. The commercial dispute is therefore likely to center on formulation, dosing, absorption, and manufacturing claims rather than basic composition-of-matter exclusivity.

How does U.S. Patent 11,304,960 compare with approved oral testosterone products?

The principal U.S. oral testosterone undecanoate products include Jatenzo, Tlando, and Kyzatrex. Their approval dates and formulations differ, and FDA approval does not establish that any product practices U.S. Patent 11,304,960.

Product	Sponsor or manufacturer	Active ingredient	FDA approval	General formulation distinction
Jatenzo	Clarus Therapeutics	Testosterone undecanoate	2019	Oral TU capsule with food-dependent administration
Tlando	Lipocine Inc.	Testosterone undecanoate	2022	Oral TU product with twice-daily administration
Kyzatrex	Marius Pharmaceuticals	Testosterone undecanoate	2022	Oral TU softgel with dose titration and food administration

Jatenzo, Tlando, and Kyzatrex are approved under different product-development and regulatory strategies. Their labels establish clinical dosing and safety requirements, but they do not by themselves disclose whether each product contains the claimed combination of glyceryl monolinoleate and polyoxyl 40 hydrogenated castor oil.

Jatenzo

Jatenzo is an oral testosterone undecanoate product approved for testosterone replacement in adult males with hypogonadism associated with an associated medical condition. Its labeling uses food administration and dose adjustment based on testosterone measurements. The product’s regulatory and patent position must be assessed through its FDA-approved labeling, Orange Book entries, and listed patent information.[2]

Tlando

Tlando is also an oral testosterone undecanoate product and is commercially relevant because its development was associated with Lipocine, a company active in oral lipid-based testosterone delivery. Tlando’s approval creates potential formulation overlap questions, but ownership, prosecution history, and actual product composition must be tied to the relevant patent family before infringement conclusions can be made.[3]

Kyzatrex

Kyzatrex is another oral testosterone undecanoate product. Its presence increases competitive pressure on formulation patents because it provides a separate commercial platform that may use a different lipid and capsule architecture. A different excipient system can materially reduce literal infringement exposure under claim 1.[4]

What is the Orange Book status of U.S. Patent 11,304,960?

A patent number alone does not establish Orange Book listing status. Orange Book listing is product-specific and depends on whether the patent claims the approved drug, an approved formulation or composition, or an approved method of use under FDA listing rules.[5]

For U.S. Patent 11,304,960, the key Orange Book questions are:

Is the patented composition used in an FDA-approved testosterone undecanoate product?
Does the patent owner or NDA holder list the patent for that product?
Does the listed patent claim the approved formulation or an approved method of use?
Has FDA accepted the listing, and is the patent still within its listing period?
Does the product have an approved generic or 505(b)(2) pathway that triggers a Paragraph IV certification?

A composition patent covering a commercial formulation can create a listing-based delay for an ANDA or certain 505(b)(2) applications. The patent does not automatically create a regulatory bar merely because it covers an oral TU formulation.

When does U.S. Patent 11,304,960 lose exclusivity?

The enforceable term normally runs for 20 years from the earliest effective U.S. nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any applicable statutory corrections.[6]

The patent number and claim text supplied do not establish the earliest priority date, patent-term adjustment, terminal disclaimer status, or any patent-term extension. An exact expiration date therefore cannot be stated reliably from the provided record.

For commercial diligence, the controlling documents are:

The patent face and continuity data;
The earliest effective nonprovisional filing;
USPTO Patent Center;
Any terminal disclaimer;
Patent-term adjustment calculation; and
FDA Orange Book patent-term information, if the patent is listed against an approved product.

The patent’s effective commercial life may be shorter than its nominal term if a competing product avoids the claims, if the patent is invalidated, or if the patent is not listed for the relevant NDA.

Which companies could face patent risk from this patent?

Potential exposure is highest for companies developing solid or semisolid oral TU products using both glyceryl monolinoleate and polyoxyl 40 hydrogenated castor oil.

Direct formulation competitors

Lipocine and affiliates developing lipid-based oral testosterone products;
Sponsors of follow-on oral TU products;
Generic or 505(b)(2) applicants relying on an approved oral TU product; and
Contract manufacturers using a supplied formulation rather than an independently developed formulation.

Lower-risk competitors

A product may reduce literal infringement exposure by using:

A liquid rather than solid or semisolid dosage form;
A different lipid carrier;
A carrier outside the 50% to 70% range;
A different surfactant;
Polyoxyl 40 hydrogenated castor oil outside the 10% to 20% range; or
A different testosterone ester.

These changes require separate evaluation under the doctrine of equivalents. A design-around that changes only a nominal percentage may remain vulnerable if the formulation performs substantially the same function in substantially the same way.

What Paragraph IV challenges and litigation issues are likely?

An ANDA applicant seeking approval of a generic oral TU product would need to address listed patents through Paragraph III, Paragraph IV, or another applicable certification pathway. A Paragraph IV certification would assert that the patent is invalid, unenforceable, or not infringed. If the NDA holder sues within the statutory period, FDA approval may be delayed under the Hatch-Waxman framework.[7]

The most plausible Paragraph IV arguments against claim 1 would include:

The claimed combination was obvious over lipid-based oral TU formulations;
Glyceryl monolinoleate and polyoxyl 40 hydrogenated castor oil were known excipients for lipid delivery;
The claimed ranges lack unexpected results across their full scope;
The carrier and surfactant percentages are indefinite or internally inconsistent;
The claims lack written description for the full range of dosage forms; and
A proposed product does not contain the required ingredients or percentages.

The strongest patent-owner arguments would include:

Unexpected absorption or food-effect performance;
A specific technical contribution from the combination of GML and polyoxyl 40 hydrogenated castor oil;
Consistent testosterone exposure across the claimed solid and semisolid formats;
Narrowing during prosecution that overcame prior art; and
Commercial evidence linking the claimed formulation to product performance.

No settlement terms, consent judgment, or Paragraph IV litigation outcome should be inferred solely from the claim text. Those issues require review of the patent family, FDA listing records, ANDA litigation docket, and any license or settlement filings.

What generic launch scenarios exist?

Scenario	Likely pathway	Effect of Patent 11,304,960
Generic copies the claimed excipient system	ANDA or 505(b)(2) with Paragraph IV risk	High formulation-infringement exposure
Generic uses a different lipid carrier	ANDA or 505(b)(2)	Lower literal infringement risk
Product uses the same ingredients but outside claimed ranges	Paragraph IV or noninfringement position	Depends on “about” and equivalents
Product is liquid	Different dosage-form strategy	Stronger noninfringement position under claim 1
Product uses a different TU formulation but seeks the same indication	505(b)(2) or other regulatory route	Claim 2 may create additional method or functional issues
Product launches after patent expiry	ANDA or 505(b)(2)	Patent barrier removed, subject to other listed patents

A competitor should not rely on one percentage change without reviewing the specification and prosecution history. Range claims often produce disputes over endpoint inclusion, measurement methods, rounding, and the meaning of “about.”

What manufacturing and intellectual-property barriers remain?

The patent may create barriers beyond the final composition. A commercial process may require:

Controlled heating to dissolve or disperse testosterone undecanoate;
Homogeneous mixing of the lipid carrier and surfactant;
Controlled cooling or solidification;
Management of viscosity and fill weight;
Protection from oxidation;
Consistent unit-dose content; and
Stability testing for a semisolid or paste-like dosage form.

Those manufacturing steps may be covered by separate process patents or trade secrets. A formulation design-around can also create new manufacturing problems, including poor content uniformity, leakage, altered food effect, or reduced shelf stability.

Geographically, U.S. Patent 11,304,960 has no direct blocking effect outside the United States. International exposure depends on corresponding patent applications, national-stage grants, expiration dates, prosecution outcomes, and local claim scope. A U.S. noninfringement position does not establish freedom to operate in Europe, Canada, Japan, or other markets.

Key Takeaways

U.S. Patent 11,304,960 is directed to a specific oral TU lipid formulation, not testosterone undecanoate generally.
Claim 1 requires approximately 15% TU, 50% to 70% lipophilic carrier containing glyceryl monolinoleate, 10% to 20% polyoxyl 40 hydrogenated castor oil, a solidifying agent, and a solid or semisolid dosage form.
The “comprising” language permits additional ingredients but does not eliminate the required identity and percentage limitations.
Claim 2 adds twice-daily dosing with food and a 250 ng/dL to 1,200 ng/dL steady-state plasma testosterone range.
The carrier and surfactant percentage architecture creates both infringement leverage and claim-clarity risks.
Products using a different lipid carrier, a liquid dosage form, or materially different surfactant concentrations may have stronger noninfringement positions.
Jatenzo, Tlando, and Kyzatrex are the principal U.S. oral TU comparators, but FDA approval does not establish practice of this patent.
Exact patent expiration and Orange Book status are product-specific and depend on the patent’s priority, term-adjustment, disclaimer, and listing records.
The most important diligence documents are the full patent, prosecution history, continuity data, FDA Orange Book records, approved labels, and any Paragraph IV litigation or settlement filings.

FAQs About U.S. Patent 11,304,960

Does the patent cover all oral testosterone undecanoate capsules?

No. The supplied claim requires a specific lipid carrier, glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil in a defined range, a solidifying agent, and a solid or semisolid dosage form.

Can a product avoid the patent by using a liquid formulation?

A liquid product has a stronger noninfringement position because claim 1 expressly requires a jelly, solid, semisolid, or paste-like composition. The full patent and equivalents analysis remain controlling.

Does claim 2 require every patient to reach 250 ng/dL to 1,200 ng/dL?

The claim requires the composition to provide that plasma range at steady state under the stated dosing conditions. The absence of a specified dose, sampling protocol, and assay method may create claim-construction and proof disputes.

Could a formulation with 9% polyoxyl 40 hydrogenated castor oil infringe?

It may avoid literal infringement of the 10% to 20% limitation, but the result depends on how “about” is construed and whether the patent owner asserts the doctrine of equivalents.

Is U.S. Patent 11,304,960 necessarily listed in the Orange Book?

No. Listing depends on whether the patent claims an approved drug, formulation, or method of use and whether it has been properly submitted and accepted for the relevant NDA.

References

United States Patent and Trademark Office. (2022). U.S. Patent No. 11,304,960.
U.S. Food and Drug Administration. (2019). Jatenzo (testosterone undecanoate) prescribing information.
U.S. Food and Drug Administration. (2022). Tlando (testosterone undecanoate) prescribing information.
U.S. Food and Drug Administration. (2022). Kyzatrex (testosterone undecanoate) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
United States Code. (2023). 35 U.S.C. §§ 154, 156.
United States Code. (2023). 21 U.S.C. § 355(j); 35 U.S.C. § 271(e).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	11,304,960	⤷ Start Trial	Y			TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	095538	⤷ Start Trial
Australia	2010203457	⤷ Start Trial
Australia	2014232475	⤷ Start Trial
Australia	2019200097	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,304,960

Which drugs does patent 11,304,960 protect, and when does it expire?

Summary for Patent: 11,304,960