United States Patent 9,415,038: Claim Scope, Exclusivity, and Omidenepag Isopropyl Patent Landscape

U.S. Patent No. 9,415,038 protects low-concentration ophthalmic preparations containing omidenepag isopropyl, including the 0.002% strength used in Omlonti. Its claims cover the formulation, eye-drop dosage form, and administration of one or two drops once or twice daily for glaucoma or ocular hypertension. The patent does not claim omidenepag isopropyl as a chemical compound generally. Its commercial value is concentrated in the marketed ophthalmic formulation and dosing regimen.

What does U.S. Patent 9,415,038 protect?

The patent covers a pharmaceutical preparation containing:

The active ingredient omidenepag isopropyl, identified by its full chemical name in the claims;
The active ingredient at 0.001% to 0.003% weight/volume;
Treatment or prevention of glaucoma or ocular hypertension;
An eye-drop dosage form;
Administration by ocular instillation;
Once-daily or twice-daily dosing;
One or two drops per administration;
Treatment of human patients.

The broadest independent formulation claim is claim 1. Claims 2 through 8 narrow the concentration range or identify discrete concentrations. Claims 9 through 15 extend protection to the dosage form and method of treatment.

Claim architecture

Claim group	Subject matter	Practical significance
Claim 1	Preparation containing 0.001% to 0.003% w/v omidenepag isopropyl or a salt	Principal composition claim
Claims 2-5	Nested concentration ranges	Provides fallback positions around the commercial strength
Claims 6-8	Enumerated concentrations from 0.0010% to 0.0030%	Attempts to capture individual strengths within the range
Claim 9	Eye drop containing the preparation	Dosage-form claim
Claims 10-15	Treatment method, instillation, dosing frequency, drops per dose, human patient	Use and administration claims

The claims use “comprising,” which generally makes them open-ended. A competing product containing the claimed active ingredient and concentration could fall within the claims even if it includes additional excipients, preservatives, buffers, surfactants, viscosity agents, or packaging components.

What concentration does the patent cover?

Claim 1 covers 0.001% to 0.003% w/v. Converted into conventional concentration units, this equals:

Claimed concentration	Equivalent amount
0.001% w/v	0.01 mg/mL
0.002% w/v	0.02 mg/mL
0.003% w/v	0.03 mg/mL

The 0.002% strength marketed as Omlonti falls directly within claim 1 and within the narrower ranges in claims 2 through 5. It is also expressly identified in claims 6 and 7.

Why the nested ranges matter

The claims create overlapping protection:

Claim 1: 0.001% to 0.003%;
Claim 2: 0.0011% to 0.0030%;
Claim 3: 0.0011% to 0.0029%;
Claim 4: 0.0013% to 0.0027%;
Claim 5: 0.0015% to 0.0025%.

A product at 0.002% would satisfy every one of claims 1 through 8, assuming the other limitations are met. The narrowing claims do not materially expand commercial coverage, but they provide multiple dependent-claim positions in validity or enforcement proceedings.

Does Patent 9,415,038 cover Omlonti?

Yes. Omlonti is an ophthalmic solution containing 0.002% omidenepag isopropyl. The FDA-approved labeling identifies the recommended dosage as one drop in the affected eye once daily. That product profile corresponds directly to claim 1, claim 9, claim 10, claim 11, claim 13, claim 14, and claim 15 of U.S. Patent 9,415,038.[2]

Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. The labeled indication fits the disease limitations in the patent claims.[2]

How strong is the patent estate for omidenepag isopropyl?

Patent 9,415,038 is commercially important but technically narrow. It protects a specific concentration window and administration method rather than the active molecule across all uses and dosage forms.

Strengths

The claims cover the approved 0.002% product strength.
The composition claim can apply to manufacture, sale, or importation of a formulation containing the specified active ingredient and concentration.
The eye-drop claim supports product-focused enforcement.
The method claims track the FDA-approved once-daily dosing regimen.
The nested claims provide alternative positions if the broad range is challenged.

Limitations

The patent does not claim omidenepag isopropyl as a molecule independently.
It does not expressly claim every ophthalmic formulation containing the active ingredient.
A formulation outside the claimed concentration range may avoid literal infringement, subject to claim-construction and equivalents issues.
The method claims may be more difficult to enforce against generic manufacturers because ANDA-based infringement disputes generally focus on the proposed label and product.
The claims do not identify specific excipients, pH, osmolarity, preservative system, container, particle size, manufacturing process, or stability profile.

The patent is therefore best characterized as a formulation-and-use patent, not the foundational compound patent for the omidenepag isopropyl program.

What formulations are protected by U.S. Patent 9,415,038?

The patent claims do not require a particular excipient system. A formulation may fall within claim 1 if it contains the claimed active ingredient at a concentration between 0.001% and 0.003% w/v and is intended for the claimed glaucoma or ocular-hypertension use.

Potentially covered products include:

Preserved ophthalmic solutions;
Preservative-free solutions;
Multidose eye-drop products;
Unit-dose containers;
Buffered formulations;
Formulations with different tonicity agents;
Formulations with different viscosity modifiers;
Salt-containing versions of the active ingredient.

The claim language expressly includes “a salt thereof.” That broadens the active-ingredient limitation beyond the named neutral compound, although the precise interpretation depends on the chemical form used and the patent’s specification.

The claims do not expressly cover:

A formulation containing no omidenepag isopropyl;
A concentration below 0.001% or above 0.003%;
A non-ocular dosage form;
A formulation used for an unrelated indication;
A manufacturing process that does not itself meet the composition limitations.

When does U.S. Patent 9,415,038 lose exclusivity?

The patent was issued on August 16, 2016.[1] Its enforceable term is determined by the patent’s effective filing and priority dates, any terminal disclaimer, and patent-term adjustment. The patent is associated with the omidenepag isopropyl formulation program and has a nominal expiration in the early 2030s, subject to the official USPTO term calculation.

FDA regulatory exclusivity is separate from patent term. Omlonti received FDA approval in September 2022. As a new chemical entity, it received five years of statutory data exclusivity, subject to any applicable pediatric extension.[2][3]

Exclusivity category	Relevance to Omlonti
Patent exclusivity	Controlled by the term of U.S. Patent 9,415,038 and other relevant patents
NCE exclusivity	Generally bars an ANDA submission for five years after approval
Paragraph IV pathway	May permit an ANDA submission during the final year of NCE exclusivity
Pediatric exclusivity	Adds six months only if formally granted
Orphan exclusivity	Not the principal exclusivity mechanism identified for Omlonti

Patent expiration and FDA exclusivity expiration are not interchangeable. FDA exclusivity can prevent an ANDA filing before patent expiry, while a patent can continue blocking approval or launch after regulatory exclusivity ends.

What is the Orange Book status of omidenepag isopropyl?

The relevant FDA reference product is Omlonti ophthalmic solution, 0.002%, marketed by Santen Pharmaceutical Co., Ltd. The Orange Book is the controlling source for listed patents and regulatory exclusivity associated with the approved product.[4]

Patent 9,415,038 is relevant to Omlonti because its claims read on the approved active ingredient, strength, eye-drop dosage form, and once-daily administration. Orange Book listing, however, is an FDA administrative listing and does not establish that every claim is valid or infringed.

For an ANDA applicant, the commercial effect is substantial if the patent is listed against the reference product. A proposed product with the same active ingredient and strength could trigger a Paragraph IV certification if the applicant seeks approval before the listed patent expires.

What Paragraph IV challenges could affect Omlonti?

A generic applicant could challenge the patent through an ANDA Paragraph IV certification. The principal possible grounds would include:

Invalidity

A challenger could argue that the concentration range lacks novelty or inventive step over earlier omidenepag formulations, glaucoma therapies, or routine dose-ranging work. The patent holder would likely rely on the specific efficacy, safety, tolerability, or dose-selection results supporting the claimed low concentration.

Noninfringement

A generic applicant could propose:

A concentration below 0.001%;
A concentration above 0.003%;
A different active ingredient;
A product with a label that omits the patented indication or dosing instruction;
A formulation that does not satisfy the claimed chemical-form limitation.

A concentration-based design-around would face practical constraints. The FDA-approved Omlonti strength is 0.002%, and a generic applicant seeking an equivalent product would generally need to match the reference product’s strength and dosage form.

Written description or enablement

The concentration claims enumerate narrow ranges and individual values. A challenge could examine whether the specification adequately supports the full range, the salt forms, and the claimed clinical uses. The patent’s validity would depend on the disclosure and prosecution history, not the claim text alone.

Obviousness-type double patenting

If related patents claim the compound, salts, formulations, or methods, a challenger could examine whether overlapping patent terms are supported by terminal disclaimers or whether the claims improperly extend exclusivity.

No Paragraph IV litigation outcome can be inferred from the claims alone. A definitive litigation assessment requires the current Orange Book listing, ANDA notices, district-court complaints, docket activity, and any settlement documents.

What patent litigation affects Omlonti?

The supplied patent claims do not identify litigation, settlements, or a generic challenger. Patent 9,415,038 should be reviewed with the following litigation questions:

Issue	Relevance
ANDA filing	Establishes whether a generic applicant has sought approval
Paragraph IV notice	Determines whether the patent has been directly challenged
45-day suit	Affects the FDA approval stay
30-month stay	May delay approval after a timely infringement action
Claim construction	Determines how “pharmaceutical preparation,” concentration, and “salt thereof” are interpreted
Settlement terms	May establish an agreed generic launch date
Orange Book delisting	Could remove the patent from the regulatory certification framework

A patent lawsuit involving another omidenepag patent could also affect commercial entry even if Patent 9,415,038 is not litigated. Compound, polymorph, salt, formulation, manufacturing, and method-of-use patents may create cumulative barriers.

Which companies are associated with omidenepag isopropyl?

Santen is the principal commercial sponsor associated with Omlonti in the United States. Omidenepag isopropyl was developed through the Santen and UBE pharmaceutical collaboration. The relevant competitive set includes:

Santen Pharmaceutical;
UBE Corporation and related predecessor entities associated with discovery and development;
Generic ophthalmic manufacturers capable of filing an ANDA;
Developers of alternative glaucoma agents, including prostaglandin analogues, rho-kinase inhibitors, beta blockers, carbonic anhydrase inhibitors, and alpha agonists.

Omidenepag isopropyl is an EP2 receptor agonist. Its commercial differentiation is based on a distinct pharmacologic mechanism and the once-daily ophthalmic formulation approved for elevated intraocular pressure.[2]

How does the patent estate compare with competing glaucoma products?

Product category	Primary protection profile	Generic risk pattern
Omidenepag isopropyl	Compound, formulation, dosage, and method patents may overlap	ANDA challenge focused on listed patents and 0.002% formulation
Latanoprost and other prostaglandin analogues	Older compound and formulation estates	Mature generic competition
Netarsudil	Compound, formulation, and use patents	Later-stage formulation and method challenges
Fixed-combination drops	Combination, ratio, formulation, and use patents	More complex ANDA and equivalence analysis
Biologic ocular products	Biologic exclusivity and biosimilar pathway	Biosimilar rather than conventional ANDA framework

Omlonti is a small-molecule ophthalmic drug. Biosimilar risk is therefore not the applicable regulatory framework. The relevant threat is an ANDA-approved generic, not a biosimilar.

What manufacturing and intellectual-property barriers remain?

Even if a generic company avoids one patent, it may face other barriers:

Reproducing the reference concentration accurately;
Demonstrating pharmaceutical equivalence;
Matching the dosage form and delivery system;
Establishing impurity and degradation controls;
Handling the active ingredient’s salt or solid-state form;
Demonstrating container-closure compatibility;
Avoiding process or crystallization patents;
Addressing listed method-of-use patents;
Managing patent-term and regulatory-exclusivity timing.

The formulation patent does not itself disclose every manufacturing barrier. A commercial freedom-to-operate review should include related U.S. and international patent-family members covering the active compound, intermediates, salts, polymorphs, ophthalmic compositions, production processes, and clinical uses.

What generic launch scenarios exist?

Launch after patent expiry

This is the lowest-risk path if no other unexpired patent blocks the product and FDA exclusivity has expired.

Paragraph IV launch after challenge

An ANDA applicant may challenge the patent and seek approval before expiration. A timely infringement action can trigger the statutory approval stay. The applicant may launch at risk after the relevant stay or litigation constraints end.

Section viii carve-out

If the listed patent claims only a method of use that can be omitted from the generic label, an applicant may seek a label carve-out. This strategy is less useful where the patent claims the formulation and strength, as claim 1 does here.

Formulation design-around

A product outside 0.001% to 0.003% may avoid literal infringement, but it may not qualify as an equivalent generic to Omlonti. The regulatory and commercial value of this strategy is therefore limited.

What is the geographic coverage of the patent?

U.S. Patent 9,415,038 provides enforceable rights in the United States and its territories covered by U.S. patent law. It does not create protection in Europe, Japan, China, Canada, or other markets.

The international landscape must be evaluated through the patent family and national-phase grants. Foreign family members may have different:

Claim scope;
Expiration dates;
Validity outcomes;
Patent-term adjustments or extensions;
Supplementary protection certificates;
Orange Book-equivalent listing systems;
Generic litigation records.

A U.S. freedom-to-operate conclusion cannot be extended automatically to other jurisdictions.

Key Takeaways

U.S. Patent 9,415,038 is a formulation-and-use patent for omidenepag isopropyl.
Claim 1 covers 0.001% to 0.003% w/v, including Omlonti’s 0.002% ophthalmic solution.
The patent also covers eye drops and once- or twice-daily instillation of one or two drops.
The claims do not independently cover omidenepag isopropyl as a chemical compound.
The patent uses overlapping concentration ranges and discrete concentration claims as fallback positions.
Omlonti is a small-molecule drug, so generic ANDA competition, not biosimilar substitution, is the relevant entry pathway.
FDA approval and NCE exclusivity began in September 2022, while patent protection extends into the early 2030s based on the patent term framework.
A complete launch-risk analysis must consider related compound, salt, polymorph, manufacturing, formulation, and method-of-use patents in addition to Patent 9,415,038.

FAQs About U.S. Patent 9,415,038 and Omlonti

Does Patent 9,415,038 cover the 0.002% Omlonti product?

Yes. The 0.002% strength falls within the broad range in claim 1 and the narrower ranges and enumerated concentrations in claims 2 through 8.

Can a generic manufacturer avoid the patent by changing preservatives?

Changing preservatives alone would generally not avoid claim 1 if the product still contains omidenepag isopropyl at a covered concentration and is intended for the claimed ophthalmic use.

Is omidenepag isopropyl protected by a biosimilar exclusivity period?

No. Omidenepag isopropyl is a small molecule regulated through the ANDA generic-drug pathway rather than the biosimilar pathway.

Do the claims cover twice-daily treatment?

Yes. Claim 12 expressly covers instillation once or twice daily. Claims 10 and 11 establish the broader treatment and instillation limitations.

Does the patent protect omidenepag isopropyl outside ophthalmic preparations?

No. The claims are directed to pharmaceutical preparations and administration for glaucoma or ocular hypertension. They do not claim unrestricted systemic, oral, injectable, or non-ocular use.

References

United States Patent and Trademark Office. (2016). U.S. Patent No. 9,415,038, pharmaceutical preparation for treatment or prevention of glaucoma or ocular hypertension.
U.S. Food and Drug Administration. (2022). Omlonti (omidenepag isopropyl ophthalmic solution) prescribing information. Santen Pharmaceutical Co., Ltd.
U.S. Food and Drug Administration. (2024). FDA regulatory exclusivity and patent information for approved drug products. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. 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
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS	⤷ 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	2015205188	⤷ Start Trial
Brazil	112016015763	⤷ Start Trial
Canada	2936026	⤷ Start Trial
Chile	2016001756	⤷ Start Trial
China	105899209	⤷ Start Trial
China	108743587	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 9,415,038