US Patent 10,179,127: Omidenepag Isopropyl Claims, Exclusivity, and Generic-Entry Risk

US Patent 10,179,127 protects a glaucoma and ocular-hypertension preparation containing 0.002% w/v omidenepag isopropyl, including use as an eye drop and once-daily instillation. The patent is formulation- and dosing-specific rather than a broad chemical-composition patent. Its commercial relevance is tied to Omlonti, the FDA-approved omidenepag isopropyl ophthalmic solution.

The claims cover:

0.002% w/v omidenepag isopropyl, or a salt;
treatment or prevention of glaucoma and ocular hypertension;
monotherapy use;
eye-drop delivery;
topical instillation;
one or two drops per dose;
once- or twice-daily administration;
once-daily administration of one drop to a human patient.

The principal commercial exposure is an ANDA product that matches the patented concentration and dosing regimen. A product using a different concentration, a combination formulation, or a materially different treatment regimen would require separate claim analysis.

What drug and formulation does US Patent 10,179,127 protect?

The claimed active ingredient is isopropyl (6-{4-(pyrazol-1-yl)benzylaminomethyl}pyridin-2-ylamino)acetate, commonly known as omidenepag isopropyl.

Claim 1 requires a pharmaceutical preparation containing 0.002% w/v of the compound or a salt. That concentration equals:

Measurement	Equivalent amount
0.002% w/v	0.002 g per 100 mL
Concentration	0.02 mg/mL
Concentration	20 micrograms/mL
Approximate 30 microliter drop	0.6 micrograms
Approximate 50 microliter drop	1.0 microgram

The claim does not expressly require a particular preservative, buffer, pH, viscosity modifier, container, tonicity agent, or bottle design. Those features may be protected by other patents or may affect infringement only if incorporated into a dependent claim or claim construction.

The claim also covers a salt of the active compound. A generic developer cannot necessarily avoid claim 1 by using a pharmaceutically acceptable salt if the resulting preparation falls within the claim's compound-and-concentration requirements.

What are the independent claims in US Patent 10,179,127?

The patent has three principal independent claim categories.

Claim	Category	Core requirement
1	Composition	0.002% w/v omidenepag isopropyl or a salt for glaucoma or ocular hypertension
6	Eye drop	An eye drop comprising the preparation of claim 1
7	Method	Administering the preparation of claim 1 to treat or prevent glaucoma or ocular hypertension

Claims 2 through 5 narrow claim 1. Claims 8 through 16 narrow the method claim.

This structure gives the patent multiple enforcement routes:

A formulation manufacturer may face composition claims.
A finished-dose ophthalmic product may face the eye-drop claim.
A prescriber-directed or labeled treatment regimen may implicate method-of-use claims.
A generic applicant may need to address both product and method claims in its ANDA certifications.

How do the dependent claims narrow the patent scope?

Claims 2 and 3 separate glaucoma from ocular hypertension. Claim 2 is limited to treatment of glaucoma. Claim 3 is limited to treatment of ocular hypertension.

Claims 4 and 5 address monotherapy:

Claim 4 requires that the preparation does not include other therapeutic agents for glaucoma.
Claim 5 requires that the preparation is not used in combination with other glaucoma therapies.

These claims are narrower than claim 1. A combination product may fall outside claims 4 and 5 while still potentially infringing claim 1, depending on the meaning of “comprising” and the relevant claim construction. Because claim 1 uses “comprising,” the presence of an additional ingredient does not automatically eliminate infringement of claim 1.

Claims 12 through 15 focus on administration:

Claim	Regimen
12	Instillation
13	Once or twice daily
14	One or two drops
15	One drop once daily
16	Human patient

Claim 15 is commercially important because it aligns closely with the labeled Omlonti regimen. The FDA-approved label directs administration of one drop in the affected eye once daily. [2]

What is the technical scope of the once-daily dosing claims?

Claim 15 requires three linked elements:

A preparation within claim 7;
Administration by the claimed treatment method;
One drop administered once daily.

The claim does not specify drop volume. A generic product that delivers a different drop volume may still satisfy the claim if the product is administered as one drop once daily. Drop size may become relevant to bioequivalence, product performance, and written-description or enablement arguments, but the claim language itself does not impose a microliter limitation.

Claim 13 covers once- or twice-daily administration. Claim 15 is narrower and more commercially targeted. A product labeled for twice-daily dosing could avoid claim 15 but could still fall within claim 13 if the other limitations are met.

The claim set does not expressly require:

a particular bottle;
a particular preservative;
a particular pH;
a particular buffer;
a particular viscosity;
a particular particle size;
a particular manufacturing process; or
a fixed administration volume.

What is the FDA regulatory status of omidenepag isopropyl?

The FDA approved Omlonti ophthalmic solution 0.002% on September 9, 2022, for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. The product contains omidenepag isopropyl as the active ingredient. [2]

Regulatory item	Status
Brand	Omlonti
Active ingredient	Omidenepag isopropyl
Dosage form	Ophthalmic solution
Strength	0.002%
FDA approval	September 9, 2022
Indication	Primary open-angle glaucoma and ocular hypertension
Labeled dose	One drop in the affected eye once daily
Regulatory pathway	New drug application

The FDA granted five-year new chemical entity exclusivity if the active moiety qualified for NCE treatment. On that basis, the regulatory exclusivity period runs generally until September 9, 2027. NCE exclusivity is separate from patent protection and does not itself establish patent validity or patent enforceability. [3]

What is the Orange Book status of US Patent 10,179,127?

US Patent 10,179,127 is associated with the Omlonti product and is relevant to the FDA Orange Book patent framework. The Orange Book listing must be evaluated together with the product's listed patent use code and expiration information. [3]

An Orange Book listing can affect ANDA timing in two ways:

A generic applicant must make a certification regarding the listed patent.
A Paragraph IV certification can trigger patent litigation and a potential 30-month approval stay under the Hatch-Waxman statute.

The Orange Book does not determine whether a patent is valid or infringed. It identifies patent information submitted by the NDA holder or applicant and accepted for listing under FDA procedures.

The practical Orange Book question is whether the patent is listed against the specific Omlonti strength and whether its use code covers the labeled glaucoma or ocular-hypertension indication. A current Orange Book entry, rather than the patent document alone, controls the operative listing and expiration information.

When does US Patent 10,179,127 lose exclusivity?

The patent issued on January 15, 2019. Public patent records associate it with a 2015 priority filing. On that basis, the ordinary 20-year patent term is expected to extend into 2035, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any correction in the official USPTO record. [1]

The relevant exclusivity timeline is:

Event	Date or expected timing
Earliest reported priority	2015
Patent grant	January 15, 2019
FDA Omlonti approval	September 9, 2022
NCE exclusivity end	Generally September 9, 2027
Expected ordinary patent-term horizon	2035, subject to USPTO term calculation

The patent is therefore more important after the NCE period ends. Before September 2027, an ANDA applicant faces both regulatory exclusivity and patent barriers. After that date, the patent may remain a standalone barrier if it is valid, enforceable, listed, and not successfully challenged.

Patent-term extension under 35 U.S.C. § 156 is generally limited to regulatory review of the approved product and is subject to statutory requirements. The precise expiration date should be taken from the USPTO patent-term data and current Orange Book listing, not inferred solely from the issue date.

What Paragraph IV challenges could target this patent?

A generic applicant seeking approval before patent expiration could submit a Paragraph IV certification asserting that the listed patent is invalid, unenforceable, or not infringed. Potential challenge theories include:

lack of written description for the precise 0.002% concentration;
lack of enablement across the full scope of the claimed compound or salts;
anticipation by an earlier omidenepag formulation or treatment disclosure;
obviousness based on known prostaglandin-related glaucoma therapies and disclosed concentration ranges;
indefiniteness of terms such as “pharmaceutical preparation,” “eye drop,” or “one drop”;
non-infringement based on a different concentration, indication, or label;
non-infringement of monotherapy claims where the product or use includes other glaucoma agents;
absence of a claimed human-treatment indication in the proposed label.

The strongest non-infringement route would usually involve a product or label that does not contain the claimed 0.002% concentration or does not include the patented treatment method. That strategy has commercial limits because the FDA-approved Omlonti regimen itself is closely aligned with claims 1, 7, 12, 14, 15, and 16.

Under Hatch-Waxman, the NDA holder generally has 45 days after receiving notice of a Paragraph IV certification to file an infringement action. A timely action can trigger a statutory stay of FDA approval, generally up to 30 months, subject to statutory exceptions and court action. [4]

Are biosimilars relevant to this patent?

No. Omidenepag isopropyl is a chemically synthesized small molecule, not a biologic. The relevant competitive pathway is an ANDA for a generic ophthalmic product, not a biosimilar application under the Public Health Service Act.

Generic applicants would need to address:

pharmaceutical equivalence;
strength and dosage form;
inactive ingredients;
ophthalmic product quality;
sterility;
stability;
container-closure integrity;
bioequivalence or other FDA-accepted comparative evidence; and
listed patent certifications.

The absence of a biosimilar pathway does not reduce patent risk. For ophthalmic products, manufacturing and quality-control requirements can create practical barriers even when the active ingredient is chemically simple.

What formulation and manufacturing barriers exist?

The patent claims do not expressly require a unique manufacturing process. They focus on the active ingredient, concentration, dosage form, indication, and regimen.

Potential non-patent barriers include:

achieving a stable 0.002% solution;
maintaining sterility over the labeled shelf life;
controlling extractables and leachables from the container;
matching drop size and delivery performance;
reproducing preservative and pH characteristics;
demonstrating ophthalmic tolerability;
establishing comparable impurity profiles; and
qualifying a manufacturing process for commercial-scale sterile filling.

These barriers do not independently extend patent exclusivity. They can, however, delay generic development and increase the cost of a Paragraph IV strategy.

Which companies are commercially relevant?

Santen Pharmaceutical Co., Ltd. developed omidenepag and is associated with the Omlonti product. Bausch + Lomb has been publicly identified as the U.S. commercial partner for Omlonti. [5]

The competitive field includes established prostaglandin analogues and other intraocular-pressure-lowering therapies, including latanoprost, bimatoprost, travoprost, beta blockers, carbonic anhydrase inhibitors, alpha agonists, and rho-kinase inhibitors.

The patent's commercial differentiation is not a broad monopoly over glaucoma treatment. It is a narrower protection for omidenepag isopropyl at the approved 0.002% ophthalmic concentration and associated treatment regimen.

How strong is the patent estate for Omlonti?

US 10,179,127 has meaningful product and method coverage because its claims map directly onto the approved product:

Commercial element	Covered by the claim set?
Omidenepag isopropyl	Yes
0.002% strength	Yes
Ophthalmic preparation	Yes
Eye-drop dosage form	Yes
Glaucoma treatment	Yes
Ocular-hypertension treatment	Yes
Once-daily use	Yes
One-drop administration	Yes
Human use	Yes
Combination therapy	Limited by claims 4 and 5, but claim 1 is broader

The estate is strongest against a generic that copies the approved Omlonti strength and label. It is weaker against products that use a different concentration, omit the patented indication from the label, or pursue a materially different regimen.

The patent does not, on the face of the supplied claims, protect every omidenepag isopropyl product, every glaucoma indication, or every ophthalmic formulation. It is not a complete substitute for reviewing related compound, formulation, manufacturing, salt, crystal-form, and dosing patents in the same family or related families.

What litigation and settlement issues affect generic entry?

The supplied claim set does not establish whether a Paragraph IV notice has been served, whether a district-court action has been filed, or whether a settlement agreement exists. Those issues depend on current ANDA filings, Orange Book certifications, court dockets, and confidential commercial agreements.

If a Paragraph IV case is filed, the key disputes are likely to concern:

Whether the generic contains 0.002% omidenepag isopropyl.
Whether its proposed label induces use for glaucoma or ocular hypertension.
Whether the generic label includes once-daily, one-drop administration.
Whether “or a salt thereof” covers the proposed active form.
Whether the claims are valid over prior art on omidenepag and prostaglandin-related glaucoma treatment.
Whether a combination product can avoid the monotherapy limitations while still infringing the broader composition claim.

A settlement could permit a generic launch before the patent's ordinary expiration date, subject to antitrust scrutiny and FDA approval. A “launch at risk” would expose the generic sponsor to damages and injunctive risk if the patent is later upheld and found infringed.

How does this patent compare with ordinary glaucoma patents?

US 10,179,127 differs from many older glaucoma patents in three respects:

It claims a specific active ingredient rather than a broad therapeutic class.
It claims a specific commercial concentration, 0.002% w/v.
It combines composition and method claims around a once-daily, one-drop regimen.

Compared with a broad compound patent, it is narrower. Compared with a conventional formulation patent, it is more closely tied to the active ingredient and treatment indication. Its value comes from alignment with the approved product, not from coverage of the entire glaucoma market.

Key Takeaways

US 10,179,127 covers 0.002% w/v omidenepag isopropyl, including salts.
The claims cover pharmaceutical preparations, eye drops, and treatment methods.
The most commercially important claims track the Omlonti label: one drop once daily for glaucoma or ocular hypertension.
Claims 4 and 5 add monotherapy limitations, but claim 1 is broader because it uses “comprising.”
Omlonti received FDA approval on September 9, 2022.
NCE exclusivity generally runs to September 9, 2027, while the patent is expected to remain relevant into 2035, subject to official term calculations.
Generic competition would proceed through the ANDA pathway, with Paragraph IV certification as the principal early-entry challenge.
Biosimilar approval is not relevant because omidenepag isopropyl is a small molecule.
The patent is strongest against a generic that copies the approved 0.002% concentration and once-daily, one-drop regimen.
The supplied claims do not by themselves establish current litigation, settlement, terminal-disclaimer, or final Orange Book expiration status.

FAQs About US Patent 10,179,127

Does US Patent 10,179,127 cover Omlonti?

Yes. The claimed 0.002% omidenepag isopropyl ophthalmic preparation corresponds to the active ingredient and strength of Omlonti.

Can a generic avoid the patent by using a different drop volume?

Not necessarily. The claims specify one or two drops but do not specify a microliter drop volume. A different drop volume may avoid infringement only if another claim limitation is also absent or if the product otherwise falls outside the claim scope.

Does adding another glaucoma drug avoid infringement?

It may avoid the narrower monotherapy claims 4 and 5, but it would not automatically avoid claim 1, which uses “comprising.”

Is a salt of omidenepag isopropyl covered?

Claim 1 expressly includes the compound “or a salt thereof,” subject to the remaining claim limitations.

Can a generic launch before 2035?

Potentially, if it obtains approval after overcoming NCE exclusivity and patent barriers, prevails in Paragraph IV litigation, reaches a settlement permitting earlier entry, or launches at risk. The patent's enforceable expiration date must be confirmed from official USPTO and Orange Book records.

References

United States Patent and Trademark Office. (2019). US Patent No. 10,179,127, Pharmaceutical preparation.
U.S. Food and Drug Administration. (2022). Omlonti (omidenepag isopropyl ophthalmic solution) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.
Bausch + Lomb. (2022). Bausch + Lomb and Santen announce U.S. commercialization agreement for Omlonti.

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	10,179,127	⤷ 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
Denmark	3093018	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,179,127

Which drugs does patent 10,179,127 protect, and when does it expire?

Summary for Patent: 10,179,127