Details for Patent: 12,290,511

Which drugs does patent 12,290,511 protect, and when does it expire?

Patent 12,290,511 protects OMLONTI and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 12,290,511

Title:	Pharmaceutical preparation containing pyridyl aminoacetic acid compound
Abstract:	The present invention aims to find a pharmaceutical preparation which treats or prevents glaucoma or ocular hypertension and is effective for patients with inadequate efficacies of glaucoma or ocular hypertension therapeutic agents. It has been found that omidenepag, an ester thereof, or a salt thereof has an excellent intraocular pressure lowering efficacy on patients with inadequate efficacies of other glaucoma or ocular hypertension therapeutic agents. Therefore, the omidenepag, the ester thereof, or the salt thereof of the present invention is useful as a pharmaceutical preparation which can treat or prevent glaucoma or ocular hypertension even in patients with inadequate efficacies of other glaucoma or ocular hypertension therapeutic agents.
Inventor(s):	Hisashi Kawata, Noriko Kawabata, Naveed Shams
Assignee:	Santen Pharmaceutical Co Ltd
Application Number:	US18/314,909
Patent Claim Types: see list of patent claims	Use; Composition;

Scope and Claims of US Patent 12,290,511 (Omidenepag/Omidenepag Isopropyl for Latanoprost-Inadequate Glaucoma)

US Patent 12,290,511 claims a patient-selection and treatment-escalation method for glaucoma or ocular hypertension in which latanoprost efficacy is inadequate (or disease is “resistant” to latanoprost) and the clinician then administers an ophthalmic pharmaceutical preparation containing omidenepag (including esters, salts, and with a dependent claim explicitly covering omidenepag isopropyl) at specific exposure thresholds for intraocular pressure (IOP) response.

The patent’s protection is concentrated on:

1. A quantitative IOP-response “failure” criterion for latanoprost using either (a) absolute drop in IOP or (b) relative percentage drop;
2. A subsequent switch/escalation to omidenepag (or ester/salt);
3. A dose-content window for the active in the formulation; and
4. Latanoprost first / omidenepag second stepwise workflows and confirmation steps.

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What is US Patent 12,290,511 and what does it claim?

Executive summary: US 12,290,511 protects method-of-treatment claims for glaucoma/ocular hypertension that is not adequately controlled by latanoprost as defined by specific IOP reduction thresholds, followed by administration of omidenepag (or ester/salt), with dependent claims limiting formulation strength and molecule identity (omidenepag isopropyl) and requiring ophthalmic administration.

Core claim architecture

The independent claim set (claims 1, 7, and the procedural variants 8–10) all center on:

• Condition: glaucoma or ocular hypertension where latanoprost is inadequate.
• Failure definition (IOP response thresholds):
  • (a) “width of decrease” between pre-treatment IOP and post-treatment IOP is 4.5 mmHg or less, OR
  • (b) “rate of decrease” between pre-treatment IOP and post-treatment IOP is 18% or less.
• Intervention: administer an ophthalmic pharmaceutical preparation containing omidenepag, an ester thereof, or a salt thereof.
• Workflow options:
  • simultaneous selection based on inadequate latanoprost efficacy (claim 1),
  • “resistant to latanoprost” framing (claim 7),
  • two-step clinician decision tree (claim 8),
  • confirmation then omidenepag administration (claim 9),
  • confirmation plus resistant labeling (claim 10).

Claim 1: “latanoprost-inadequate patient” selection + omidenepag administration

Claim 1 is the main scope anchor:

• Method: treating glaucoma or ocular hypertension.
• Administer: omidenepag (or ester/salt) in a pharmaceutical preparation.
• Patient subgroup: patient with “inadequate efficacies of latanoprost” such that when subjected to latanoprost:
  • IOP decrease is ≤4.5 mmHg (absolute) or
  • IOP decrease rate is ≤18% (relative).

Practical claim meaning: any clinical regimen that uses latanoprost, measures IOP, determines that the response does not meet either threshold, and then uses omidenepag-based ophthalmic treatment can fall within the claimed method, provided the formulation identity is met.

Claim 7: “glaucoma/ocular hypertension resistant to latanoprost” framing

Claim 7 overlaps claim 1 but recasts the cohort as diseases resistant to latanoprost and retains the same IOP failure thresholds.

Practical impact: “resistance” language can capture datasets/claims where resistance is defined clinically or in trials, even if documentation uses “resistant” terminology rather than “inadequate efficacy.”

Claims 8–10: decision-tree and confirmation workflow

These claims add method steps that can be used against parties who argue they “didn’t do the switch” or “didn’t decide based on a threshold”:

• Claim 8: explicit steps
  1. first administer latanoprost,
  2. judge inadequacy using the same IOP criteria (≤4.5 mmHg or ≤18%),
  3. then administer omidenepag preparation when inadequacy is found.
• Claim 9: confirm the patient meets the criterion, then administer omidenepag.
• Claim 10: confirm glaucoma and ocular hypertension are resistant to latanoprost based on the thresholds, then administer omidenepag.

Practical impact: these procedural claims can target:

• clinical protocols,
• label-adjacent treatment algorithms,
• payer/digital therapeutic decision logic,
• investigator-initiated switching designs,
• and potentially manufacturer-supported “step-up” pathways.

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Which omidenepag forms are covered by US 12,290,511?

Executive summary: The claims cover omidenepag and specifically include esters, salts, with a dependent claim narrowing to omidenepag isopropyl. This matters for formulation design, Paragraph IV/IX-style noninfringement arguments, and licensing scope.

Claim scope of active ingredient

• Claims 1 and 7: omidenepag or an ester thereof or a salt thereof
• Claim 2: treatment sequence includes latanoprost then further treating by lowering IOP with omidenepag
• Claim 5: specifies omidenepag isopropyl
• Claim 6: requires ophthalmic administration

Implication for formulation/IP design: a challenge that a competitor uses a different ester/salt form can be addressed by the broad “ester thereof / salt thereof” language, while the dependent claim to isopropyl provides extra fall-back coverage if isopropyl is used.

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What are the key IOP-response thresholds defining “inadequate efficacy” of latanoprost?

Executive summary: The patent uses two alternative quantitative response thresholds after latanoprost exposure to identify the protected patient population:

• absolute IOP decrease ≤ 4.5 mmHg, or
• relative IOP decrease rate ≤ 18%.

Threshold mechanics embedded in the claims

The claims reference:

• “width of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure”
  -> treated as absolute reduction in mmHg; threshold 4.5 mmHg.
• “rate of decrease between pre-treatment intraocular pressure and post-treatment intraocular pressure”
  -> treated as percentage reduction; threshold 18%.

How this defines infringement risk

• If a competitor’s clinical protocol switches patients after observing outcomes above the threshold (for example, greater than 4.5 mmHg absolute drop and/or greater than 18% rate), the protocol may fall outside the patient cohort as written.
• If the competitor’s outcomes routinely place a patient at ≤4.5 mmHg or ≤18%, the decision step maps tightly to the claim language.

Litigation leverage created by threshold duality

Having two independent “or” conditions helps the patentee:

• It reduces how a defendant can escape by arguing measurement method, because both absolute and percentage thresholds are claimed.

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What formulation concentration is protected for omidenepag in US 12,290,511?

Executive summary: Dependent claims narrow to specific w/v active content ranges:

• 0.001 to 0.003% (w/v) (claim 3)
• 0.002% (w/v) (claim 4)

Claim 3: range

• Omidenepag (or ester/salt) content: 0.001 to 0.003% (w/v).

Claim 4: specific point

• Omidenepag (or ester/salt) content: 0.002% (w/v).

How concentration limits interact with independence scope

Claim 1’s independent scope does not, on its face, include the concentration limit; claims 3 and 4 provide narrower fallback positions. A manufacturer designing around may consider concentration, but method claims still require the presence of the active ingredient in a “pharmaceutical preparation,” and the independent claim’s lack of a concentration limit increases exposure.

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What do the step-sequence claims mean for clinical practice and protocol design?

Executive summary: Claims 2 and 8–10 emphasize latanoprost-first treatment followed by omidenepag only after a threshold-based determination of inadequate IOP lowering.

Claim 2: explicit “latanoprost then further treat”

Claim 2 states the method includes:

• treating with latanoprost, then
• further treating by lowering IOP with the omidenepag preparation.

Claim 8: three-step decision tree

1. administer latanoprost;
2. judge inadequacy using the same IOP thresholds;
3. administer omidenepag preparation when inadequacy exists.

Claim 9 and 10: confirmation-first variants

• claim 9: confirm the patient is inadequate and then administer omidenepag.
• claim 10: confirm resistance in glaucoma and ocular hypertension by the thresholds and then administer.

Protocol risk points

• If a clinical pathway switches therapy based on IOP outcomes after latanoprost and uses omidenepag, the protocol aligns closely with claims 8–10.
• If the pathway uses omidenepag without a latanoprost failure determination, the stronger overlap is with claim 1/7 only if it still involves identifying “inadequate efficacy” patients based on prior latanoprost.

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How strong is the patent estate for omidenepag-based latanoprost failure switching in the US?

Executive summary: A precise strength assessment requires the full US patent record (including the underlying publication, priority chain, prosecution history, and whether additional claims appear in the published application). That record is not included in the prompt. With only claim text provided, strength can be assessed only at the claim-language level: the patent is tightly anchored to a quantitative IOP threshold and to the omidenepag active/formulation framework, limiting off-scope arguments while narrowing design-around space for substitution of active ingredient class or omission of threshold-based selection.

Claim-language features that typically improve enforceability

• Objective numeric criteria (≤4.5 mmHg or ≤18%) reduce reliance on subjective terms.
• Specific active ingredient linkage (omidenepag and its chemical variants).
• Structured treatment workflow (latanoprost first then decision then omidenepag).

Claim-language features that typically raise invalidity/contestable interpretation risk

• Terms like “width of decrease” and “rate of decrease” can invite argument about:
  • measurement timing after latanoprost,
  • which eye is used,
  • baseline and follow-up definitions. Those issues are claim-construction dependent and depend on the full spec and prosecution history.

No landscape conclusions beyond the claim text should be treated as definitive without the patent bibliographic data and cited art set.

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What generic or biosimilar entry risks exist for method claims like these?

Executive summary: The risk profile is driven less by “generic omidenepag formulation” (which might be outside the method claims if the switch decision is not implemented) and more by whether a product is used in a regimen that satisfies the patented threshold-based latanoprost failure selection steps.

Likely infringement pathways

• Direct use: a clinician prescribes omidenepag to a patient previously assessed as inadequate on latanoprost per the thresholds.
• Protocol-level inducement: label/IFU, clinical guidance, copay programs, and investigator materials that promote switching when response is ≤4.5 mmHg or ≤18%.

Design-around levers

• Change clinical decision thresholds (avoid the defined cohort).
• Use an active not covered by “omidenepag/ester/salt.”
• Avoid latanoprost exposure and the “judge inadequacy then switch” workflow.

These levers are theory-level and depend on how closely real-world treatment aligns with claim steps.

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What is the likely geographic and regulatory relevance of US 12,290,511?

Executive summary: The claims are US method claims and target US treatment practices using omidenepag in the context of latanoprost inadequacy. Regulatory relevance is operational, because the method claims are tied to measurable outcomes after latanoprost and to omidenepag dosing in ophthalmic form.

Regulatory artifacts that matter in enforcement

• US prescribing information for omidenepag product(s) (if it contains latanoprost failure switching language).
• Clinical trial protocols and post-marketing studies that include latanoprost run-in and switch criteria aligned with the numeric thresholds.
• Any patient-selection language in label or IFU referencing IOP reduction thresholds.

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Key patent-scope map (claim-by-claim)

Claim	Core protection	Latanoprost criterion used?	Omidenepag form	Formulation content limits	Administration type
1	Treat glaucoma/OHT by administering omidenepag (ester/salt) to latanoprost-inadequate patients	Yes: ≤4.5 mmHg OR ≤18%	Omidenepag, ester, salt	Not limited in claim 1	Implied ophthalmic (explicit in claim 6)
2	Latanoprost then further treat with omidenepag to lower IOP	Yes (sequence)	Omidenepag (per claim 1)	Not limited	Not limited
3	Same method as claim 1 with content window	Yes	Omidenepag/ester/salt	0.001 to 0.003% (w/v)	Not limited
4	Same method as claim 1 with specific content	Yes	Omidenepag/ester/salt	0.002% (w/v)	Not limited
5	Same method with active identity	Yes	Omidenepag isopropyl	Not limited	Not limited
6	Same method with administration route	Yes	Omidenepag/ester/salt	Not limited	Ophthalmic administration
7	Treat “latanoprost-resistant” glaucoma/OHT using omidenepag	Yes: same thresholds	Omidenepag/ester/salt	Not limited	Not limited
8	Two-step switching algorithm: latanoprost, judge inadequacy, then omidenepag	Yes: same thresholds	Omidenepag/ester/salt	Not limited	Not limited
9	Confirm patient meets threshold failure then administer omidenepag	Yes: same thresholds	Omidenepag/ester/salt	Not limited	Not limited
10	Confirm resistance in both glaucoma/OHT then administer omidenepag	Yes: same thresholds	Omidenepag/ester/salt	Not limited	Not limited

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What potential infringement and noninfringement arguments are built into these claims?

Executive summary: The patent is drafted so that both patient cohort definitions and treatment sequencing are embedded. The strongest noninfringement argument typically turns on whether the patient truly meets the threshold “failure” definition under the relevant measurement assumptions.

Noninfringement angles that map to claim text

• No inadequate latanoprost efficacy: if the measured response after latanoprost is >4.5 mmHg and >18%, the patient is not in the claimed cohort.
• No omidenepag/ester/salt: if the administered drug is not within “omidenepag, an ester thereof, or a salt thereof,” the claim is not met.
• Different active concentration: dependent claims 3 and 4 require specific content; if only those claims are asserted, a content change can matter. Claim 1 still lacks a content requirement.

Infringement angles enabled by procedural claims

• A party that implements a “latanoprost first then switch when IOP response is within the defined failure window” has a closer fit to claims 8–10.

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Key Takeaways

• US 12,290,511 protects method-of-treatment using omidenepag (or ester/salt) for glaucoma or ocular hypertension where latanoprost response is inadequate by numeric criteria.
• The claimed “inadequate efficacy” hinges on either ≤4.5 mmHg absolute IOP reduction or ≤18% relative IOP reduction after latanoprost.
• The patent includes workflow claims (latanoprost first, judge response, then switch to omidenepag), which can target protocol-driven switching and clinical guidance.
• Dependent claims add formulation content limits (0.001 to 0.003% w/v; or specifically 0.002% w/v) and narrow the active to omidenepag isopropyl and ophthalmic administration.

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FAQs

1) Does US 12,290,511 require that omidenepag be given after a specific duration of latanoprost?
The claims require the patient is “subjected to treatment with latanoprost” and then assessed by IOP response thresholds; the prompt text does not specify a duration, which is determined by claim construction and specification.

2) If a patient’s IOP reduction is 4.6 mmHg but only 17% relative reduction, is that within the claim?
Yes in principle, because the criterion is disjunctive: the thresholds are ≤4.5 mmHg OR ≤18%.

3) Can a formulation that uses omidenepag but at a concentration outside 0.001–0.003% still infringe?
It can still fall under the broader independent method claim (claim 1) because concentration limits are in dependent claims 3 and 4.

4) What matters more for infringement: baseline IOP or follow-up IOP timing after latanoprost?
Both are embedded in the “pre-treatment” and “post-treatment” IOP measurements used to compute the absolute and relative reductions; timing and measurement definitions are claim-construction dependent.

5) Is the invention limited to monotherapy switching, or can it include adjunctive care?
The claim text specifies administering latanoprost first and then administering the omidenepag preparation when the criterion is met; it does not expressly exclude other co-therapies, but infringement depends on how “the method” is performed in practice.

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References

No sources were provided in the prompt other than the claim text.

Drugs Protected by US Patent 12,290,511

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes						METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS

International Family Members for US Patent 12,290,511

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3087019
China	111526876
European Patent Office	3733179
Japan	7346305