Details for Patent: 12,605,391

Which drugs does patent 12,605,391 protect, and when does it expire?

Patent 12,605,391 protects JATENZO and is included in one NDA.

Summary for Patent: 12,605,391

Title:	Methods of treating testosterone deficiency
Abstract:	Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. In some embodiments, the subject has adequately controlled blood pressure.
Inventor(s):	Robert E. Dudley, Theodore Danoff, James A. Longstreth
Assignee:	Tolmar Inc
Application Number:	US18/086,994
Patent Claim Types: see list of patent claims	Use; Composition;

Executive summary: US Patent 12,605,391 claims a tightly framed oral testosterone undecanoate dosing and administration protocol for testosterone deficiency states, with an explicit blood-pressure monitoring condition and a defined two-times-daily dose set (158/198/237/316/396 mg), paired with a specific solubilization system (hydrophilic surfactant plus lipophilic surfactant). Claim scope is concentrated on (i) method-of-treatment using an oral testosterone undecanoate composition with defined surfactant architecture and digestible-oil option and (ii) conditional treatment management tied to baseline adequate blood pressure and monitoring after administration, including average ambulatory BP change. The strongest infringement and freedom-to-operate risk centers on products that match the claimed dose range and twice-daily morning/evening schedule and use the same surfactant pairs (e.g., oleic acid + hydrogenated castor oil ethoxylate) and similar concentration and lipophilic:hydrophilic ratios.

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US Patent 12,605,391 scope and claim coverage: what does it actually protect?

US 12,605,391 is not drafted as a broad composition patent alone; it is a method-of-treatment patent that is enabled by a specific oral testosterone undecanoate formulation architecture and a post-dose blood pressure management protocol.

Core claim architecture (what must be present for infringement)

Claim 1 requires all of the following, in combination:

1. Patient condition: subject with “one or more conditions associated with a deficiency or absence of endogenous testosterone.”

   • Claim 1 includes hypogonadism categories via dependent claims (primary hypogonadism; hypogonadotropic hypogonadism).

2. Drug and regimen: administering testosterone undecanoate in an oral pharmaceutical composition twice daily, with a morning dose and an evening dose.

3. Defined dose set: the “defined dose” is selected from 158 mg, 198 mg, 237 mg, 316 mg, 396 mg of testosterone undecanoate.

4. Blood pressure condition:

   • baseline: subject has “adequately controlled blood pressure at the time the oral pharmaceutical composition is first administered.”
   • monitoring: monitoring subject’s blood pressure after administration of the defined dose.

5. Formulation limitation tied to solubilization:

   • testosterone undecanoate is “solubilized in a carrier comprising at least one hydrophilic surfactant and at least one lipophilic surfactant.”

Claim 1 therefore locks infringement to both how the product is used (dose schedule, baseline BP adequacy, monitoring) and what the product contains (surfactant solubilization system and, via dependent claims, specific surfactants/ratios).

What is not claimed directly

Based on the claim set provided, the patent does not primarily claim:

• a novel chemical structure of testosterone undecanoate,
• a general method of testosterone replacement without the surfactant-carrier constraint,
• unrestricted dosing schedules (it is explicitly morning + evening, twice daily, and restricted to the enumerated dose options),
• a generic “monitor BP in any context” protocol without the baseline adequate BP condition and the claimed dose/route.

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Claim-by-claim scope: how do claims 2–18 narrow or expand US 12,605,391 coverage?

Claim 1 (independent): the infringement “center of mass”

Claim 1 is the primary fence.

• Treatment population: testosterone deficiency/absence.
• Route: oral pharmaceutical composition.
• Drug: testosterone undecanoate.
• Dosing pattern: twice daily (morning and evening).
• Dose options: 158/198/237/316/396 mg.
• Baseline BP: “adequately controlled” at first administration.
• Monitoring: blood pressure monitoring after administration.
• Formulation: testosterone undecanoate solubilized in a carrier containing at least one hydrophilic surfactant and at least one lipophilic surfactant.

This is a combination claim. In practice, a design-around can be attempted at multiple points: dose selection, schedule, baseline BP condition, monitoring step content, or surfactant architecture.

Claims 2–3: antihypertensive therapy status

• Claim 2: subject is not being treated with antihypertensive therapy.
• Claim 3: subject is being treated with antihypertensive therapy.

These claims largely expand coverage to cover both treated and untreated hypertension background scenarios, preventing an easy escape by selecting only “no antihypertensive” patients.

Claim 4: new-onset hypertension or exacerbation treatment overlay

• Adds: “further comprising treating the subject for new-onset hypertension or exacerbation of pre-existing hypertension.”

This adds a therapeutic management step. If a product label or investigator practice includes treatment of emergent BP effects, it may land inside this dependent claim as well.

Claims 5 and 7: informed consent / warning step content

• Claim 5: prior to administration, informing subject that administration may result in an increase in blood pressure.
• Claim 7: prior to administration, informing subject of additional BP increases with:
  • prescription medications known to increase BP,
  • nonprescription analgesics,
  • cold medications.

These claims matter less for product manufacturing infringement and more for induced/direct method use arguments in litigation, because they target the prescriber/patient counseling protocol.

Claim 6: quantified ambulatory BP increase

• “average increase of systolic blood pressure of 4.9 mm Hg based on ambulatory blood pressure monitoring.”

This clause can become a litigation fulcrum. If accused product use in a trial or real-world shows a different mean change, the patentee may still argue equivalence/meeting the claim through evidence tied to the asserted use regimen. Practically, the claim is biomarker-anchored.

Claim 8: monitoring for new-onset or exacerbation

• “monitoring the subject for new-onset hypertension or exacerbation of pre-existing hypertension.”

This duplicates the monitoring concept but ties it specifically to the clinical endpoints.

Claim 9: cardiovascular risk factor or established CVD

• Expands inclusion criteria to higher-risk patients.

Claim 10: dose lock to 237 mg

• Limits to defined dose = 237 mg. If accused regimen includes any other enumerated dose, this dependent claim may not read, but claim 1 still can.

Claims 11–12: specific hypogonadism etiologies

• primary hypogonadism
• hypogonadotropic hypogonadism

These dependent claims expand coverage to specific subpopulations within the broader testosterone deficiency umbrella.

Claims 13, 14, 18: specific surfactant identifications

• Claim 13: lipophilic surfactant is a fatty acid.
• Claim 14: hydrophilic surfactant is hydrogenated castor oil ethoxylate.
• Claim 18: lipophilic surfactant is oleic acid and hydrophilic surfactant is hydrogenated castor oil ethoxylate.

These are the tightest formulation-identifying claim elements. A product that uses different hydrophilic/lipophilic surfactants may avoid these dependent claims even if it still uses “at least one” of each class for claim 1.

Claim 15: digestible oil inclusion

• Oral composition further comprises a digestible oil.

Claim 16: active concentration window

• composition comprises about 18–22% (w/w) testosterone undecanoate.

This is a design-around lever: if an accused product’s testosterone undecanoate content falls outside the claimed range, it may defeat claim 16 (and in combination may weaken overall matching if other dependent limitations are asserted).

Claim 17: surfactant ratio window

• ratio (w/w) total lipophilic surfactant : total hydrophilic surfactant is ~6:1 to ~3.5:1.

This ratio can be decisive. Even if the product uses the same classes, a different ratio may avoid claim 17 and the more specific claims tied to preferred surfactants.

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What formulations are protected by US 12,605,391?

The formulation boundary inside a method claim

Even though the document is framed as a method, the formulation is required. The protected “carrier” is defined by:

• solubilization of testosterone undecanoate in a carrier with:
  • at least one hydrophilic surfactant and
  • at least one lipophilic surfactant.

The dependent claims then sharpen:

• hydrophilic surfactant: hydrogenated castor oil ethoxylate
• lipophilic surfactant: fatty acid (and in one version oleic acid)
• digestible oil optional
• testosterone undecanoate: about 18–22% w/w
• lipophilic:hydrophilic surfactant ratio: ~6:1 to ~3.5:1

Design-around map (formulation levers)

To fall outside the strictest dependent claim set, a competitor can:

• use a different hydrophilic surfactant class or different named hydrophilic surfactant,
• use different lipophilic surfactants not fatty-acid based or not oleic acid,
• change the lipophilic:hydrophilic ratio outside ~6:1 to ~3.5:1,
• change testosterone undecanoate concentration outside ~18–22% w/w,
• omit a digestible oil (if claim 15 is asserted, it is still dependent).

The catch in infringement is claim 1 still captures “at least one” hydrophilic and “at least one” lipophilic surfactant carrier. So changing specifics may avoid dependent coverage, but not necessarily claim 1 if the accused formulation still has both surfactant classes arranged to solubilize.

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When does testosterone undecanoate oral exclusivity end if US 12,605,391 is asserted?

No Orange Book expiry, patent term expiration date, or FDA exclusivity dates are provided in the prompt. Without the patent’s USPTO data (issue/filing dates) and without the Orange Book reference product listing details, an exclusivity/timing schedule cannot be produced from the claim text alone.

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What other patents typically surround a US method claim like 12,605,391? (landscape structure)

The claim style strongly suggests that US 12,605,391 is part of a broader patent estate in oral testosterone undecanoate. Typical neighboring claim families in this space include:

1. Composition claims for oral testosterone undecanoate solubilized in surfactant systems (hydrophilic + lipophilic).
2. Dosage form claims with digestible oils and fixed concentration ranges (e.g., 18–22% w/w active).
3. Dosing regimen claims for twice daily morning/evening administration.
4. Cardiovascular monitoring and warnings claims tied to blood pressure increases and patient counseling.
5. Dose selection claims that enumerate dose levels used in pivotal pharmacokinetic and safety studies.
6. Patient population subclaims: hypogonadism subtype.

Landscape risk pattern for generics and “section IV” pathways

Given the claim reliance on specific regimen and formulation solubilization, a generic entrant’s principal risk is not only whether the active is “the same,” but whether:

• the generic matches the surfactant carrier structure such that testosterone undecanoate is solubilized using hydrophilic and lipophilic surfactants,
• the generic label and instruction align with baseline BP adequacy and monitoring steps,
• the generic’s dose options match the enumerated set used in claim 1 and depends.

If the generic can change its composition to avoid the specific carrier architecture and avoid matching the dependent ratios/concentrations, the infringement story changes. If it cannot, the method claim can support induced infringement theories tied to label instructions and prescriber use.

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How strong is the patent estate around US 12,605,391 based on claim constraints?

Based only on the claim text, strength indicators are:

Strong points

• Specific dosing set and schedule: enumerated mg amounts and twice-daily morning/evening structure.
• Formulation tethering inside a method claim: carrier must contain both hydrophilic and lipophilic surfactants to solubilize the drug.
• Clinical management steps: baseline adequate BP and post-dose monitoring reduce the scope to a defined “safety/management” use.
• Multiple dependent narrowings: detailed surfactant identity (hydrogenated castor oil ethoxylate; oleic acid) and ratio/concentration windows.

Pressure points

• Because the claim is a combination of regimen + baseline BP + monitoring + formulation features, a non-landing design-around can occur if an accused product:
  • uses different surfactant systems (even if testosterone undecanoate is the active),
  • changes the dose outside the enumerated options or avoids the morning/evening twice-daily schedule,
  • alters label or practice so the “adequately controlled blood pressure at first administration” condition is not met as used,
  • changes outcomes such that the average ambulatory systolic BP change is not reproducible under the claimed regimen (if claim 6 is asserted).

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What patent litigation or FDA regulatory posture risks exist for competitors?

The prompt provides only the claim text. It does not provide:

• Orange Book listing,
• FDA approval history,
• litigation docket, asserted claims, or court outcomes.

Accordingly, the litigation and regulatory risk profile cannot be mapped to case-specific milestones.

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Key Takeaways

• US 12,605,391 protects a specific oral testosterone undecanoate treatment method combining:
  • twice-daily morning/evening dosing,
  • one of five enumerated testosterone undecanoate dose levels,
  • baseline “adequately controlled” blood pressure at first administration,
  • post-dose blood pressure monitoring,
  • an oral formulation where testosterone undecanoate is solubilized in a carrier containing hydrophilic + lipophilic surfactants.
• Dependent claims sharpen risk to:
  • specific surfactant identities (hydrogenated castor oil ethoxylate; oleic acid),
  • specific concentration and ratio windows (18–22% w/w; lipophilic:hydrophilic ~6:1 to ~3.5:1),
  • counseling and warnings about BP increase interactions (prescription BP-increasing meds, analgesics, cold medications),
  • cardiovascular endpoint management (treating new-onset hypertension/exacerbations).
• In a generic or competitor analysis, the highest-risk matching factors are dose regimen fidelity and surfactant-carrier architecture. Label-driven counseling and monitoring steps become meaningful if method use is asserted.

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FAQs

1. If a competitor uses testosterone undecanoate but changes the surfactant system, which claim elements are most affected?
   The independent claim requires at least one hydrophilic and one lipophilic surfactant for solubilization, while dependent claims 13–14 and 17–18 require specific surfactant identities and ratio windows.

2. Does the patent cover both patients on antihypertensives and those not on antihypertensives?
   Yes. Claims 2 and 3 separately cover both categories, so excluding one group does not fully avoid coverage.

3. Which claims are most relevant to prescriber label and patient counseling practices?
   Claims 5 and 7 (informing patients about BP increases and interaction-related BP increases) and claims 4 and 8 (treating emergent hypertension/exacerbations and monitoring).

4. What dosing mismatch would likely avoid the narrowest dependent claim set?
   Using a dose other than the enumerated set in claim 1 avoids the dependent dose-specific claim 10 (237 mg) and can also defeat matching to claim 1 if the administered dose is not one of the listed options.

5. What formulation parameters are the most precise design-around levers?
   Testosterone undecanoate concentration (~18–22% w/w), lipophilic:hydrophilic surfactant ratio (~6:1 to ~3.5:1), and the specific surfactant pair oleic acid + hydrogenated castor oil ethoxylate.

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References

1. US Patent 12,605,391 (claims provided in prompt).

Drugs Protected by US Patent 12,605,391

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						TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No						TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes						TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE