Details for Patent: 10,702,511

Which drugs does patent 10,702,511 protect, and when does it expire?

Patent 10,702,511 protects OMLONTI and is included in one NDA.

This patent has forty-seven patent family members in twenty-six countries.

Summary for Patent: 10,702,511

Title:	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Abstract:	Provided is a pharmaceutical preparation for treatment or prevention of glaucoma or ocular hypertension, comprising 0.0003 to 0.01% (w/v) of isopropyl (6-{[4-(pyrazol-1-yl)benzyl](pyridin-3-ylsulfonyl)aminomethyl}pyridin-2-ylamino)acetate, or a salt thereof.
Inventor(s):	Naveed Shams, Henk-Andre Kroon, Hisashi Kawata, Noriko Kawabata
Assignee:	Santen Pharmaceutical Co Ltd
Application Number:	US16/211,839
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Scope and claims breakdown for US Patent 10,702,511 (isopropyl (6-{4-(pyrazol-1-yl)benzylaminomethyl}pyridin-2-ylamino)acetate) in glaucoma and ocular hypertension

US 10,702,511 is an incremental, composition-and-use patent built around a single active ingredient and a narrow concentration window in a liquid formulation, plus downstream claim coverage for eye drops and methods of treatment/prevention by topical instillation. The independent claim set is composition-focused (liquid pharmaceutical preparation with 0.001–0.003% w/v active) with concentration-specific dependent coverage (0.002% w/v), followed by clinical-use and device-administration claims that are tightly tethered to that same formulation and its “no other glaucoma therapeutic agents” limitation.

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What is US Patent 10,702,511 and what does it claim for glaucoma treatment?

Direct answer: US 10,702,511 claims a liquid pharmaceutical preparation for glaucoma or ocular hypertension containing 0.001–0.003% (w/v) of a specific compound, isopropyl (6-{4-(pyrazol-1-yl)benzylaminomethyl}pyridin-2-ylamino)acetate (or a salt), plus an additive, and it covers eye drops and topical instillation methods for treatment/prevention, including “no other glaucoma agents” and dosing-by-drop claims.

Claim architecture overview (what is independent vs dependent)

From the provided claim text:

• Claim 1: Independent composition for glaucoma/ocular hypertension
• Claim 2: Dependent on claim 1, narrows to 0.002% (w/v)
• Claims 3–6: Dependent intended-use and exclusivity vs combination therapy
• Claim 7: Eye drop comprising claim 1 composition
• Claims 8–17: Dependent methods (treatment/prevention), use limits (no other agents), route (instillation), schedule (once/twice daily), dose (1–2 drops, including 1 drop once daily), and human patient

Key claim elements to map to design-around and licensing value

1. Drug identity constraint: the active is fixed to the isopropyl ester compound (or salt).
2. Concentration window constraint: 0.001–0.003% (w/v) is the core formulation range.
3. Liquid-only and additive: “liquid pharmaceutical preparation” plus an “additive” (not quantified in your text).
4. Topical administration via instillation: method claims require instillation (eye-drop context).
5. Use limitation: claims 5–6 and 11–12 exclude other glaucoma therapeutic agents and also exclude use in combination.
6. Dosing constraints: claims 13–16 fix schedule and drop counts, with a particularly narrow “1 drop once a day” subclass.

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What is the active ingredient in US 10,702,511 and how narrowly is it defined?

Direct answer: The active ingredient is isopropyl (6-{4-(pyrazol-1-yl)benzylaminomethyl}pyridin-2-ylamino)acetate (or a salt). The claims do not cover other esters, other prodrugs, or alternative stereochemical variants unless they fall within “or a salt thereof” (which still leaves ambiguity about alternative salts not listed in the claim text you provided, but the claim language itself limits to salts of that same molecule).

Scope implications for infringement

• A generic or competitor composition using a different ester (even if pharmacologically related) is outside the literal scope unless it is a salt of the claimed compound.
• A competitor using the claimed active at an eligible concentration in a liquid will be within the strongest literal infringement zones for claims 1/2/7 and the tethered method claims 8–17.

Salt coverage

• The claim explicitly says “or a salt thereof,” so salt form does not create an easy design-around if the base molecule is the same.

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What concentration range is protected (0.001–0.003% w/v) and what does that mean for formulation design?

Direct answer: The protected composition is a liquid containing 0.001 to 0.003% (w/v) active (claim 1), with an extra dependent claim for 0.002% (w/v) (claim 2).

Concentration map

• Claim 1 window: 0.001–0.003% (w/v)
• Claim 2 point: exactly 0.002% (w/v)
• Practical boundary exposure:
  • If a competitor formulates below 0.001% or above 0.003%, it may fall outside claim 1 and thereby the tethered method claims that depend on claim 1.
  • If a competitor formulates near the middle (including exactly 0.002%), it increases risk for both claims 1 and 2.

How “additive” affects scope

Claim 1 requires “and an additive,” but your text does not specify the additive type. In typical patent scope, “additive” is broad unless limited by definition in the specification. That suggests the formulation could vary in buffers, tonicity agents, preservatives, surfactants, or viscosity modifiers while staying inside the claim, as long as the active concentration and liquid nature are preserved.

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How do the glaucoma/ocular hypertension intended-use limitations change the claim scope?

Direct answer: The independent claim language covers both glaucoma and ocular hypertension (claim 1), and claims 3 and 4 separately anchor intended use to glaucoma vs ocular hypertension.

Claim-specific intended-use hooks

• Claim 1: treatment or prevention of glaucoma or ocular hypertension
• Claim 3: preparation “for treatment of glaucoma”
• Claim 4: preparation “for treatment of ocular hypertension”

Infringement consequence

• If a competitor markets the same formulation for either indication, the “for treatment of X” framing may align with the corresponding dependent claims.
• If the product label is limited to one indication, the other dependent use claim may be more difficult to assert, but claim 1 already covers both.

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What do the “no other therapeutic agents” limitations do to combination-therapy risk?

Direct answer: Claims 5–6 and 11–12 limit coverage when the preparation is not used (or does not include) other glaucoma therapeutic agents, reducing infringement risk for combination regimens that include additional glaucoma drugs.

Claims in scope

• Claim 5: preparation does not include other therapeutic agents for glaucoma
• Claim 6: preparation is not used in combination with other therapeutic agents for glaucoma
• Claim 11: method of claim 8 where the liquid does not include other therapeutic agents
• Claim 12: method of claim 8 where the preparation is not used in combination with other therapeutic agents

Practical risk analysis for branded vs generic combination products

• Monotherapy with the claimed formulation aligns closely with claims 5 and 11 (composition not including other glaucoma agents).
• Combination therapy using other glaucoma drugs can create a non-infringement position for those dependent claims if the factual use is combination therapy.
• Note the tethering: method claims 11–12 depend on claim 8. Even if dependent “no other agent” limitations fail, claim 8 may still be asserted for treatment/prevention by instillation unless other additional limitations are not met.

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What is protected by the “eye drop comprising” claim?

Direct answer: Claim 7 covers an eye drop comprising the liquid pharmaceutical preparation of claim 1.

How that tightens enforcement

• “Eye drop” is a dosage-form framing that can support product form arguments even if a competitor tries to characterize packaging or presentation differently.
• The enforcement advantage is that it aligns the formulation to a consumer-facing delivery system that regulators and marketing materials recognize as eye-drop therapy.

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What method-of-use claims exist and how narrow are the dosing and schedule limitations?

Direct answer: Claim 8 covers administering the claim 1 formulation to a patient needing treatment or prevention of glaucoma or ocular hypertension. Claims 9–10 narrow to glaucoma vs ocular hypertension. Claims 13–17 specify route and regimen: instillation, once or twice daily, one or two drops, including one drop once daily, and a human patient.

Method claim tree

• Claim 8: treatment or prevention for glaucoma or ocular hypertension via administering claim 1 formulation
• Claim 9: glaucoma
• Claim 10: ocular hypertension
• Claim 11–12: plus “no other glaucoma therapeutic agents” inclusion/combination limits
• Claim 13: instillation
• Claim 14: once or twice a day
• Claim 15: one or two drops
• Claim 16: one drop once a day
• Claim 17: patient is human

Litigation leverage: route and schedule as factual anchors

• If a competitor’s regimen uses a different route (e.g., gel, ointment, implant, intracameral) the literal method claims for “instillation” could be harder to assert.
• If dosing is outside “once or twice a day” or outside “one or two drops,” the dependent claims 14–16 narrow to regimens. However claim 8 still covers administering the formulation unless a court requires compliance with dependent limitations for asserted claims.

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How strong is the patent estate around US 10,702,511 based on claim type?

Direct answer: The strength is structurally high for monotherapy topical liquid using the exact active at 0.001–0.003%. It is weaker for combination regimens (because of “no other therapeutic agents” dependent limitations) and for alternative regimens outside instillation and the defined dosing/schedule (because of downstream dependent limitations).

Strength drivers

• Single compound identity in composition claims
• Concentration window that can be directly mapped to formulation testing
• Eye-drop and instillation method claims that map to real-world product use
• Explicit “treatment or prevention” coverage

Potential vulnerability points (for challengers or design-around planners)

• If a challenger can invalidate claims on composition concentration range or lack of novelty/obviousness, the entire claim tree collapses because most claims depend on claim 1.
• The claim language requires “liquid pharmaceutical preparation” and “additive.” If a competitor develops a non-liquid dosage form (even with the same active and concentration, depending on how “liquid” is interpreted), it may avoid literal scope.

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Where does US 10,702,511 likely sit in the exclusivity timeline (patent term and practical expiry)?

Direct answer: The claims you provided do not include priority date, filing date, or the patent grant date. Without those, a correct US patent term and PTA/adjustment computation cannot be stated from your supplied data.

(Per constraints, no incomplete timeline is provided.)

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What is the likely FDA/Orange Book relevance for US 10,702,511 (and what would it cover if listed)?

Direct answer: If US 10,702,511 is listed in the FDA Orange Book for a glaucoma/ocular hypertension drug containing the same active compound at the specified concentration in a liquid/eye-drop product, it would be relevant to generic and 505(b)(2) applicants facing patent-citing under FDA Orange Book listing and, for paragraph IV, to infringement positions centered on:

• active identity,
• concentration in the approved formulation,
• route (eye-drop instillation),
• and use limitations (monotherapy vs combination therapy).

(Your prompt does not provide the Orange Book listing or the referenced FDA product.)

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How would a Paragraph IV challenge likely attack this patent’s scope?

Direct answer: The strongest challenge angles, based on the claim structure, target claim 1’s combination of:

• exact active identity (and/or salt),
• and the 0.001–0.003% w/v concentration window,
• and the “liquid pharmaceutical preparation” + additive requirement.

High-probability invalidity or non-infringement patterns

• Non-infringement via concentration: competitor formulates below 0.001% or above 0.003% w/v.
• Non-infringement via dosage form: competitor uses a non-liquid form or a different delivery technology not considered “liquid pharmaceutical preparation” or not an “eye drop.”
• Invalidity via prior art on the same active: earlier patents or literature on the compound for glaucoma/ocular hypertension with overlapping concentrations can challenge novelty and obviousness.
• Invalidity via formulation method differences: if prior art describes liquid formulations with overlapping concentration and additive profiles, obviousness risk increases.

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What generic entry risks exist for competitors trying to launch a similar eye drop?

Direct answer: Generic or 505(b)(2) entry risks peak when a product is developed as a topical eye drop containing the same isopropyl ester active at 0.001–0.003% (w/v) and administered by instillation, especially if marketed as monotherapy.

Risk stratification (based on your claim tree)

• Highest risk: same active, 0.001–0.003%, liquid eye drop, monotherapy, once/twice daily with 1–2 drops.
• Moderate risk: same active/concentration/route but marketed or used in combination with other glaucoma therapies (dependent “no other agents” claims become easier to defend against).
• Lower risk: outside concentration window or using a different dosage form/route not meeting “liquid” and “instillation” constraints.

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Key Takeaways

• US 10,702,511 is a single-active, concentration-defined glaucoma/ocular hypertension patent that broadly covers liquid formulations and eye-drop delivery of the specified isopropyl ester at 0.001–0.003% (w/v), with a dependent 0.002% claim.
• The strongest enforcement anchors are claims 1 and 7 (composition and eye-drop dosage form) and claim 8 (method of treatment/prevention by instillation).
• Combination therapy is carved out only through dependent limitations (“no other therapeutic agents” and “not used in combination”), reducing coverage for combination-regimen facts.
• Dosing/schedule constraints (once or twice daily; one or two drops; one drop once daily) are largely in dependent claims, so they narrow the method profile but do not remove exposure to the broader “administering” method claim.

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FAQs

1. Does US 10,702,511 cover topical glaucoma therapy outside eye drops (e.g., ointments or inserts)?
   The claims you provided are framed as “liquid pharmaceutical preparation” and “eye drop,” with methods requiring “instillation,” so non-eye-drop or non-instillation delivery forms sit outside the literal claim language as written.

2. Can a competitor avoid infringement by using a different concentration of the same active?
   A product formulated outside the 0.001–0.003% (w/v) window would not meet claim 1’s concentration element, and the tethered claims would be harder to assert.

3. Is the patent stronger for monotherapy than combination therapy?
   Dependent claims explicitly exclude “other therapeutic agents” and “combination” use, so monotherapy use facts align more tightly with those dependent claims.

4. Are the dosing claims required for infringement if claim 8 is asserted?
   The dosing schedule and drop-count limitations are in dependent claims (13–16). They are not textual requirements of claim 8, which only requires administration of the claim 1 preparation to a patient needing treatment/prevention.

5. What is the scope impact of “or a salt thereof”?
   Salt forms of the same active molecule are within the literal claim language for the compound element, so changing to a salt does not create a clean design-around by itself.

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References

No external sources were provided in the prompt, and the patent’s filing/priority details, prosecution history, claim set from the official text, and Orange Book listing status were not supplied. Therefore, no citations are included.

Drugs Protected by US Patent 10,702,511

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	10,702,511		Y			METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS

International Family Members for US Patent 10,702,511

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015205188
Brazil	112016015763
Canada	2936026