US Patent 11,179,402: Scope, Claims, Expiration, Orange Book Status, and Testosterone Undecanoate Patent Landscape

US Patent 11,179,402 protects an oral testosterone undecanoate formulation built around a liquid, capsule-encased, self-emulsifying system. The core combination is 15-20% testosterone undecanoate, 5-20% hydrophilic surfactant, and 20-80% C14-C24 fatty acid lipophilic surfactant, with an antioxidant and no monohydric alcohol. The independent claims also require twice-daily administration capable of producing testosterone concentrations of approximately 300-1,100 ng/dL.

The patent is materially narrower than a broad composition patent because infringement requires satisfaction of multiple quantitative, structural, dosage-form, excipient, and pharmacokinetic limitations. The strongest commercial relevance is to oral testosterone undecanoate products using a self-emulsifying lipid formulation, particularly products associated with the Jatenzo development program.

What does US Patent 11,179,402 cover?

US 11,179,402 covers a pharmaceutical composition suitable for oral administration in a liquid-filled capsule. The claimed formulation uses testosterone undecanoate as the active pharmaceutical ingredient and relies on a mixed surfactant system to support oral absorption.

The required elements are:

Claim element	Scope
Active ingredient	15-20% by weight testosterone undecanoate
Hydrophilic surfactant	5-20% by weight
Hydrophilic surfactant HLB	10-45 in claims 4-6 and 12-13
Lipophilic surfactant	20-80% by weight
Lipophilic surfactant identity	C14-C24 fatty acid
Lipophilic surfactant HLB	Less than 10, less than 5, or 1-2 depending on claim
Antioxidant	Required
Alcohol limitation	No monohydric alcohol
Dosage form	Liquid encased in a capsule
Dosing condition	Twice-daily administration
Pharmacokinetic result	Serum testosterone of about 300-1,100 ng/dL
Optional features	Digestible oils, rapid dissolution, self-emulsification

The patent does not claim testosterone undecanoate generally. It claims a specific oral delivery architecture designed to improve absorption of a highly lipophilic testosterone ester.

How do independent claims 1 and 12 differ?

Claims 1 and 12 are separate independent composition claims with overlapping subject matter.

Claim 1 is broader in its treatment of the surfactant classes. It requires:

15-20% testosterone undecanoate;
5-20% hydrophilic surfactant;
20-80% C14-C24 fatty acid lipophilic surfactant;
an antioxidant;
no monohydric alcohol;
a liquid-in-capsule dosage form; and
the specified twice-daily testosterone concentration.

Claim 12 is narrower because it expressly requires:

a hydrophilic surfactant having an HLB of 10-45;
specified hydrophilic surfactant classes;
a C14-C24 fatty acid selected from myristic, palmitic, stearic, oleic, linoleic, or linolenic acid;
at least one digestible oil selected from borage oil and peppermint oil; and
an antioxidant.

Issue	Claim 1	Claim 12
Hydrophilic surfactant	Broad functional category	HLB 10-45 plus closed listed classes
Lipophilic surfactant	C14-C24 fatty acid	C14-C24 fatty acid plus listed fatty acids
Digestible oil	Not required	Required
Antioxidant	Required	Required
Alcohol exclusion	Required	Required
Liquid capsule	Required	Required
Pharmacokinetic limitation	Required	Required
Relative breadth	Broader	Narrower but more composition-specific

A product may avoid claim 12 while still presenting a claim 1 issue if it uses the required broad surfactant and fatty-acid architecture but does not contain borage oil or peppermint oil.

Which dependent claims create the principal infringement risk?

Claims 6, 11, 13, 14, 15, 16, and 17 are commercially important because they identify excipients and formulation attributes commonly relevant to product development.

Hydrogenated castor oil ethoxylate claims

Claims 6 and 13 narrow the hydrophilic surfactant to a hydrogenated castor oil ethoxylate. This limitation may capture excipients such as polyoxyl hydrogenated castor oil materials, depending on the precise chemical identity, degree of ethoxylation, and claim construction.

A formulation using a different hydrophilic surfactant may avoid these dependent claims but could remain within claim 1 or claim 12.

Oleic acid claim

Claim 11 requires oleic acid as the lipophilic surfactant. Oleic acid is a particularly important limitation because it is a common liquid fatty acid used in lipid-based oral formulations. A formulation using oleic acid at the claimed concentration, together with the other required elements, faces a direct literal infringement risk under claim 11.

Self-emulsifying claims

Claims 14 and 15 require that the formulation be self-emulsifying. These claims are narrower than claims 1 and 12 because self-emulsification is an additional formulation property.

The term generally points to a system that forms an emulsion or fine dispersion after contact with gastrointestinal fluids, often with limited external energy. Whether a particular product is self-emulsifying would depend on formulation testing, dissolution behavior, droplet-size data, and the patent’s specification and prosecution history.

Antioxidant claims

Claims 16 and 17 specify ascorbyl palmitate or butylhydroxytoluene, commonly known as BHT. A product using another antioxidant may avoid these dependent claims, but it would still need to satisfy the broader antioxidant limitation in claims 1 or 12.

What formulation architecture is protected?

The patent protects a mixed hydrophilic-lipophilic surfactant system.

The hydrophilic component has an HLB of 10-45. The claimed examples include:

polyoxyethylene sorbitan fatty acid esters;
hydrogenated castor oil ethoxylates;
PEG mono- and di-esters of palmitic and stearic acids; and
fatty acid ethoxylates.

The lipophilic component is a C14-C24 fatty acid. The expressly identified candidates include:

myristic acid;
palmitic acid;
stearic acid;
oleic acid;
linoleic acid; and
linolenic acid.

The claims use HLB ranges to distinguish the two surfactant populations. Claims 7-9 further narrow the lipophilic component to an HLB below 10, below 5, or 1-2.

This structure creates a formulation-specific barrier. A competitor cannot necessarily avoid the patent merely by changing the capsule shell or adjusting the brand formulation. A meaningful design-around would generally require changing one or more of the following:

the testosterone undecanoate concentration;
the hydrophilic surfactant concentration;
the fatty-acid surfactant concentration;
the use of a C14-C24 fatty acid;
the absence of monohydric alcohol;
the liquid-in-capsule dosage form; or
the twice-daily pharmacokinetic profile.

How strong are the pharmacokinetic and dissolution limitations?

The pharmacokinetic limitation requires that twice-daily administration provide a serum testosterone concentration of about 300-1,100 ng/dL. This limitation may be significant in litigation because it links the composition to a clinical result.

A generic or competing product could argue that its formulation does not meet the claimed serum range. That defense would depend on:

dose strength;
dosing interval;
fed or fasted administration;
patient population;
sampling time;
testosterone assay methodology;
steady-state conditions; and
whether "about" permits a range broader than the literal numerical endpoints.

Claim 3 requires substantially complete release of the testosterone ester within approximately two hours in phosphate-buffered saline. This is an in vitro limitation. It can be tested directly, but the result may vary with:

buffer composition;
pH;
agitation;
apparatus;
capsule rupture;
sampling interval; and
analytical method.

The dissolution claim is narrower than the main composition claims and provides a potential non-infringement route for products with slower or differently characterized release.

What is the patent expiration date for US 11,179,402?

US Patent 11,179,402 was issued on November 30, 2021. Its enforceable term is generally calculated from the earliest effective nonprovisional filing date in the priority chain, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The patent number alone does not establish the final expiration date. For commercial diligence, the controlling records are the USPTO Patent Center continuity and term data and the FDA Orange Book listing, if any. The relevant date is the adjusted expiration date, not the issue date.

A preliminary term assessment should include:

Term issue	Relevance
Earliest effective nonprovisional filing	Establishes the base 20-year term
Patent-term adjustment	Can extend the base term
Terminal disclaimer	Can limit the term to another patent’s expiration
Patent-term extension	May apply if statutory requirements are satisfied
Patent-term disclaimer records	Must be checked in USPTO records
Orange Book expiry field	Relevant to listed-drug generic timing

What is the Orange Book status of US 11,179,402?

The patent’s commercial significance depends heavily on whether it is listed for an FDA-approved testosterone undecanoate product and which claims or use codes are associated with the listing.

The Orange Book analysis should distinguish:

composition-of-matter listings;
formulation listings;
method-of-use listings;
patents with pediatric exclusivity;
patents subject to Paragraph IV certification; and
patents that are listed but do not necessarily block all generic formulations.

A formulation patent does not automatically prevent approval of every generic testosterone product. Its practical effect depends on whether the proposed generic uses the claimed excipient system and whether the reference product’s listing creates a certification obligation under Hatch-Waxman.

The patent claims are composition claims rather than pure method-of-use claims. A generic applicant whose product label overlaps the reference product may still face a Paragraph IV issue if the listed patent is relevant to the proposed formulation or labeled use.

Which testosterone undecanoate products compete with this patent estate?

The relevant U.S. oral testosterone products include Jatenzo, Tlando, and Kyzatrex. They use oral testosterone undecanoate but have different sponsors, formulation approaches, regulatory histories, and patent portfolios.

Product	Sponsor	Active ingredient	FDA status	Patent relevance
Jatenzo	Clarus Therapeutics	Testosterone undecanoate	Approved 2019	Closely associated with oral TU formulation and patent licensing activity
Tlando	Antares Pharma, now associated with Halozyme ownership history	Testosterone undecanoate	Approved 2022	Competing oral TU product with separate formulation and patent estate
Kyzatrex	Marius Pharmaceuticals	Testosterone undecanoate	Approved 2022	Separate oral TU formulation and regulatory exclusivity profile

FDA approval does not establish that each product infringes US 11,179,402. Product-specific comparison requires analysis of the actual quantitative composition, capsule contents, excipient identities, HLB values, antioxidant, dissolution profile, and pharmacokinetic data.

What Paragraph IV and litigation risks exist?

The claims create several possible generic-entry disputes.

Literal infringement risk

The highest risk applies to a liquid-filled capsule containing:

testosterone undecanoate at 15-20% by weight;
a hydrophilic surfactant at 5-20%;
a C14-C24 fatty acid at 20-80%;
an antioxidant;
no monohydric alcohol; and
a twice-daily regimen producing the claimed testosterone range.

A product meeting those elements could fall within claim 1 even if it avoids the narrower choices in claims 6, 11, or 16.

Design-around risk

Potential design-around strategies include:

reducing testosterone undecanoate below 15% or above 20%;
shifting the fatty-acid concentration outside 20-80%;
using a non-fatty-acid lipophilic excipient;
adding a monohydric alcohol;
using a non-liquid dosage form;
using a once-daily or otherwise different dosing regimen; or
developing a formulation that does not satisfy the claimed pharmacokinetic range.

Each strategy introduces development and regulatory tradeoffs. Changes to absorption-enhancing excipients may affect food effects, exposure variability, capsule stability, and dose proportionality.

Validity issues

Potential validity arguments would focus on:

anticipation by earlier oral testosterone undecanoate formulations;
obviousness of combining known surfactants and fatty acids;
written-description support for the quantitative ranges;
enablement across the full breadth of the claims;
indefiniteness of "about," "substantially all," and the serum concentration limitation; and
whether the pharmacokinetic result is sufficiently tied to the claimed composition.

The quantitative ranges and combination of excipient classes may provide useful patentability arguments, but the strength of the claims depends on the prosecution record and the closest prior art.

How does US 11,179,402 compare with broader oral testosterone patents?

US 11,179,402 is a formulation patent. It does not provide the same exclusionary scope as a patent claiming testosterone undecanoate itself, a broad oral delivery method, or a platform covering multiple lipid systems.

Its strength is concentration in a commercially relevant formulation space. Its weakness is dependence on numerous cumulative limitations.

Patent type	Typical scope	Relevance to US 11,179,402
Active-ingredient patent	Covers the molecule or ester	Broader, but generally unavailable for older compounds
Broad oral-delivery patent	Covers oral testosterone administration	Potentially broader than the ’402 patent
Formulation patent	Covers excipient and dosage-form architecture	Directly comparable
Method-of-use patent	Covers treatment or dosing	May create separate Orange Book barriers
Manufacturing patent	Covers synthesis or encapsulation	Can create supply-chain risk without blocking finished-dose formulation

What manufacturing and IP barriers matter?

The patent is not limited to manufacturing steps, but its formulation requirements can create manufacturing barriers. A competitor must control:

precise surfactant ratios;
fatty-acid purity and oxidation control;
antioxidant selection;
capsule compatibility;
fill-weight uniformity;
liquid leakage and shell migration;
dissolution performance; and
stability over the proposed shelf life.

Oleic acid and other unsaturated fatty acids create oxidation-control requirements. The claimed use of antioxidants may be commercially important because degradation can affect both product quality and patent claim analysis.

Key Takeaways

US 11,179,402 is directed to a liquid-filled, oral testosterone undecanoate formulation.
Claims 1 and 12 are the principal independent claims.
Claim 1 is broader; claim 12 requires specified surfactant classes and borage oil or peppermint oil.
The formulation must contain 15-20% testosterone undecanoate, 5-20% hydrophilic surfactant, and 20-80% C14-C24 fatty acid.
The claims exclude monohydric alcohol and require an antioxidant.
Dependent claims add HLB ranges, oleic acid, hydrogenated castor oil ethoxylates, self-emulsification, and specified antioxidants.
The patent’s practical scope is narrower than a broad oral testosterone patent because all limitations must be satisfied.
The final expiration date requires USPTO term, continuity, adjustment, and terminal-disclaimer review.
Paragraph IV exposure depends on the reference product, Orange Book listing, and the proposed generic’s actual formulation.
The highest infringement risk concerns oral testosterone undecanoate products using a similar self-emulsifying fatty-acid surfactant system.

FAQs About US Patent 11,179,402

Does US 11,179,402 cover all testosterone undecanoate capsules?

No. It covers capsules meeting the specified composition, excipient, concentration, alcohol-exclusion, pharmacokinetic, and dosage-form limitations.

Can a formulation with oleic acid infringe US 11,179,402?

Yes. Oleic acid is expressly recited in claim 11 and is within the C14-C24 fatty-acid category. Infringement still requires satisfaction of the other claim limitations.

Does adding ethanol avoid US 11,179,402?

It may avoid the express "free of monohydric alcohol" limitation, but the effect depends on claim construction and whether the alcohol is present in the claimed formulation. It may also change the product’s absorption and regulatory profile.

Is self-emulsification required by every claim?

No. Self-emulsification is required only by claims 14 and 15. Claims 1 and 12 do not expressly require that additional limitation.

Does FDA approval of a competing oral testosterone product prove non-infringement?

No. FDA approval and patent infringement are separate inquiries. The competing product’s actual formulation and the patent’s enforceable claims must be compared element by element.

References

U.S. Food and Drug Administration. (2019). FDA approves new oral testosterone capsule for men with certain forms of hypogonadism. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.
U.S. Patent and Trademark Office. (2021). U.S. Patent No. 11,179,402. Patent Center.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term information. USPTO.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Patent and exclusivity information. FDA.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y			⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y			⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y			⤷ 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
Australia	2006236564	⤷ Start Trial
Australia	2011201422	⤷ Start Trial
Brazil	PI0607549	⤷ Start Trial
Canada	2604943	⤷ Start Trial
China	101217963	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,179,402

Which drugs does patent 11,179,402 protect, and when does it expire?

Summary for Patent: 11,179,402