US Patent 10,517,880: Claim Scope, Ryaltris Exclusivity, and Patent Landscape
US Patent 10,517,880 protects a nasal spray device containing mometasone furoate and olopatadine hydrochloride, with protection centered on spray geometry, formulation stability, particle size, viscosity, droplet size, and dose delivery. The patent is directed to the product marketed in the United States as Ryaltris. Its reported expiration date is February 14, 2037, subject to any applicable patent-term adjustment or other statutory modification. The patent does not broadly cover every combination of mometasone and olopatadine. Its strongest coverage requires a defined sprayer, an aqueous suspension, and specified spray-performance characteristics. [1][2][3]
What does US Patent 10,517,880 protect?
The patent has three principal claim groups:
| Claim group |
Claims |
Protected subject matter |
| General spray-pattern claims |
1-12, 24, 27-29 |
Sprayer containing an aqueous mometasone/olopatadine suspension with defined spray dimensions |
| Narrow 6 cm spray-pattern claims |
13-25, 29-33 |
Sprayer producing a defined major axis, minor axis, and ellipticity at 6 cm |
| Droplet-size claim |
26 |
Sprayer producing a D50 droplet size of 34.68 to 39.28 micrometers at 6 cm |
The patent combines product, device, formulation, and method-of-treatment limitations. The independent claims are not directed solely to a pharmaceutical composition. They require a sprayer containing the composition and, in most cases, require the sprayer to produce a specified spray pattern.
That structure creates a potential design-around path. A competing product may use the same active ingredients but avoid literal infringement if it does not meet the claimed spray dimensions, droplet-size range, or other required formulation limitations.
What are the independent claims in US 10,517,880?
The principal independent claims are claims 1, 2, 13, 24, 25, and 26.
Claim 1: broadest genus claim
Claim 1 covers a sprayer containing:
- An aqueous pharmaceutical composition;
- A single-phase suspension;
- Mometasone or a salt of mometasone;
- Olopatadine or a salt of olopatadine; and
- A spray pattern delivered into a human nose having:
- A longest axis of 15 to 75 mm;
- A shortest axis of 10 to 65 mm; and
- Ellipticity of 1 to 2.
Claim 1 is broad as to the chemical forms of the active ingredients. It can cover mometasone salts and olopatadine salts, not only mometasone furoate and olopatadine hydrochloride. It is narrower as to the delivery system because the claim requires the specified spray pattern.
Claim 2: commercial-product formulation
Claim 2 narrows claim 1 to:
- Mometasone furoate; and
- Olopatadine hydrochloride.
It retains the same spray-pattern limitations. This is the claim most closely aligned with the active ingredients in Ryaltris.
Claim 13: more specific spray geometry
Claim 13 requires the sprayer to deliver a spray at 6 cm having:
- A major axis of 52 to 63 mm;
- A minor axis of 47 to 53 mm; and
- Ellipticity of 1.1 to 1.2.
This claim is narrower than claim 2 in spray-performance terms. The major and minor axes describe the dimensions of the spray plume, while ellipticity limits the ratio between the two axes. A spray with a major axis of 60 mm and a minor axis of 50 mm has an ellipticity of approximately 1.2.
Claim 26: droplet-size claim
Claim 26 covers a sprayer containing:
- 25 micrograms of mometasone furoate in particulate form;
- 665 micrograms of olopatadine hydrochloride; and
- A D50 droplet size at 6 cm of 34.68 to 39.28 micrometers.
This claim does not expressly require the spray-pattern dimensions in claims 1 or 13. It creates a separate infringement route based on droplet-size testing.
What formulation is protected by US 10,517,880?
Claim 12 identifies a detailed formulation that is also incorporated into claim 23. The formulation contains the following ingredients:
| Ingredient |
Concentration |
| Mometasone furoate monohydrate |
0.025% w/w |
| Olopatadine hydrochloride |
0.665% w/w |
| Sodium carboxymethylcellulose |
0.5% w/w |
| Mixture of microcrystalline cellulose and sodium carboxymethylcellulose |
1.2% w/w |
| Benzalkonium chloride |
0.02% w/w |
| Sodium chloride |
0.41% w/w |
| Disodium edetate |
0.01% w/w |
| Sodium phosphate heptahydrate |
0.94% w/w |
| Polysorbate 80 |
0.01% w/w |
| pH |
3.3 to 4.1 |
The formulation is a single-phase aqueous suspension. Mometasone furoate is particulate, while olopatadine hydrochloride is described in dependent claims as dissolved. The hydrocolloid system helps maintain suspension stability and reduce phase separation.
The claimed formulation also includes:
- Viscosity of 20 to 150 centipoise;
- Osmolality of 250 to 350 mOsm/kg;
- Mometasone particle size of 1 to 20 micrometers;
- pH of 3.3 to 4.1, with a narrower range of 3.5 to 3.9; and
- At least 24 hours of resistance to phase separation under specified storage conditions.
These limitations provide formulation-specific protection beyond the active ingredients themselves.
How does the patent protect the spray device?
Claims 28 and 29 define the sprayer as a three-part assembly:
- A container holding the pharmaceutical composition;
- A pump communicating with the composition; and
- An actuator communicating with the top of the pump.
This is conventional nasal-spray architecture. The patent does not claim every possible atomizer or delivery platform. The claims are directed to a container-pump-actuator system that produces the defined spray characteristics.
The practical scope therefore depends on how the accused product is tested. A generic or follow-on product could use a different pump, actuator, nozzle, or formulation and potentially avoid one or more claim elements.
What are the key dependent-claim limitations?
The dependent claims add a dense set of commercial-product specifications:
| Limitation |
Claims |
| 25 micrograms mometasone furoate and 665 micrograms olopatadine hydrochloride per spray |
3 |
| Hydrocolloid |
4, 15 |
| Sodium carboxymethylcellulose |
5, 16 |
| Viscosity of 20 to 150 cP |
6, 17 |
| Phase-separation inhibition for at least 24 hours |
7, 18 |
| Mometasone particle size of 1 to 20 micrometers |
8, 19 |
| pH of 3.3 to 4.1 |
9, 20 |
| pH of 3.5 to 3.9 |
10, 21 |
| Osmolality of 250 to 350 mOsm/kg |
11, 22 |
| Specific excipient formula |
12, 23 |
| Spray stability after long-term storage |
30-33 |
| D50 droplet size of 34.68 to 39.28 micrometers |
26 |
| Particulate mometasone and dissolved olopatadine |
14, 27 |
Claims 30 through 33 are particularly relevant to product testing. They require the sprayer to retain specified spray dimensions after storage at either 25°C/60% relative humidity or 40°C/75% relative humidity.
When does US Patent 10,517,880 lose exclusivity?
The reported patent expiration date is February 14, 2037. The patent appears to be based on a February 14, 2017 priority date. Patent-term calculations should be confirmed against the current USPTO Patent Center record and the FDA Orange Book listing because patent-term adjustment can change the effective expiration date. [1][2]
The patent is distinct from FDA regulatory exclusivity. The relevant commercial timeline is:
| Event |
Date or period |
| Priority date |
February 14, 2017 |
| Patent grant |
December 31, 2019 |
| FDA approval of Ryaltris |
January 2022 |
| Reported patent expiration |
February 14, 2037 |
| Regulatory exclusivity |
Separate from patent term and dependent on FDA designation |
Ryaltris contains previously known active ingredients. Its approval therefore does not receive the five-year new chemical entity exclusivity available to a novel active moiety. Any three-year exclusivity would depend on the FDA’s treatment of the supporting clinical investigations and the specific NDA approval. Regulatory exclusivity does not independently extend the patent term. [3][4]
What is the Orange Book status of US 10,517,880?
US Patent 10,517,880 is associated with Ryaltris, FDA NDA 214426, according to FDA drug-listing and patent data. The patent’s commercial relevance comes from its relationship to the approved nasal-spray product containing mometasone furoate and olopatadine hydrochloride. [2][3]
An Orange Book listing does not establish that every claim is valid or infringed. It gives the NDA holder a statutory mechanism to receive notice of certain abbreviated new drug applications containing a Paragraph IV certification. The applicant may challenge the patent’s validity, enforceability, or scope, or may certify that the proposed product will not infringe.
The key regulatory distinction is:
- Orange Book listing identifies a patent associated with an approved drug.
- Patent litigation determines enforceability and infringement.
- FDA approval does not resolve either issue.
Which companies are exposed to this patent?
Glenmark developed the mometasone furoate and olopatadine hydrochloride combination and licensed U.S. commercial rights to Hikma Pharmaceuticals. Hikma markets Ryaltris in the United States. [5]
The principal competitive groups are:
| Company type |
Exposure |
| Hikma |
Branded U.S. commercialization of Ryaltris |
| Glenmark |
Originator and patent-holder interests |
| Generic nasal-spray companies |
Potential Paragraph IV and non-infringement challengers |
| Branded allergy competitors |
Substitution pressure from other intranasal corticosteroid and antihistamine products |
| Biosimilar developers |
No direct relevance because Ryaltris is a nonbiologic small-molecule combination |
Biosimilar risk is therefore not the relevant challenge category. The principal risks are generic entry, alternative formulation development, and substitution by competing nasal allergy products.
Which companies are challenging US Patent 10,517,880?
No specific Paragraph IV challenger, district-court infringement action, or settlement involving US 10,517,880 is established by the claim text alone. The relevant public records are FDA Paragraph IV notices, Abbreviated New Drug Application litigation filings, and USPTO or Patent Trial and Appeal Board proceedings.
A generic applicant challenging the patent would likely focus on:
- Obviousness based on known mometasone and olopatadine nasal products;
- Whether spray-pattern optimization is an expected result of routine actuator and pump selection;
- Whether the broad spray-pattern ranges are adequately enabled;
- Whether “single phase suspension” is sufficiently definite;
- Whether the claimed droplet-size range is inherent in a known device;
- Whether the claims adequately describe the full scope of the salt genus in claim 1; and
- Whether the storage-performance claims are supported by the specification.
How strong is the patent estate?
The patent has meaningful commercial value because it covers a combination of active ingredients, dose strength, suspension architecture, excipients, and delivery performance. Its strength is higher against a product closely copied from the Ryaltris formulation and device than against a product using the same active ingredients with a substantially different delivery system.
Strengths
- Claims are tied to measurable product attributes.
- Claims cover both formulation and spray-device characteristics.
- The specific dose matches the approved product.
- The formulation claims include excipient and pH limitations.
- The patent includes post-storage spray-performance claims.
- Claims 24 and 25 extend the claim set to treatment of rhinitis.
Vulnerabilities
- Spray-pattern and droplet-size measurements require defined test conditions and methods.
- The broad ranges in claim 1 may invite enablement and written-description challenges.
- Spray geometry may be characterized as an optimization of known nasal-spray technology.
- The claim language contains apparent drafting issues, including “mometasone furoate form” in claim 3 and the incomplete temperature expression in claims 30 and 31 as reproduced in the supplied text.
- Method claims 24 and 25 depend on device claims, which may complicate infringement analysis.
- The patent does not automatically block all mometasone/olopatadine products.
What generic launch scenarios exist?
Scenario 1: direct product copy
A generic using the same formulation, dose, pump, actuator, and spray geometry faces the highest infringement risk. It could trigger a Paragraph IV dispute and a potential 30-month stay under the Hatch-Waxman framework if the statutory conditions are met. [4]
Scenario 2: formulation redesign
A competitor could alter the hydrocolloid system, viscosity, particle-size distribution, pH, or excipient profile. It would still need to avoid the independent claim requirements, particularly the spray-pattern and single-phase-suspension limitations.
Scenario 3: device redesign
A different pump, actuator, nozzle, or spray plume could avoid claims 13 and 26 if the resulting spray falls outside the claimed dimensions and droplet-size range. The competitor would still need to evaluate claim 1 and the doctrine of equivalents.
Scenario 4: litigation-based launch
A generic could file Paragraph IV certifications and launch at risk after litigation, subject to the patent owner’s ability to obtain preliminary or permanent injunctive relief.
Scenario 5: post-expiration launch
Absent successful invalidation, non-infringement, or settlement, the clearest unrestricted generic-entry date is after the patent’s reported February 14, 2037 expiration.
How does US 10,517,880 compare with typical nasal-spray patent estates?
The patent is narrower than a basic composition patent but broader than a patent limited to one manufacturing process. It is a product-by-process-adjacent delivery patent because infringement depends on the characteristics of the resulting spray rather than only on the identity of the ingredients.
| Patent type |
Typical scope |
Relation to US 10,517,880 |
| Active-ingredient patent |
Covers novel chemical entity |
Not applicable; both actives were known |
| Composition patent |
Covers ingredients and concentrations |
Present through claims 2-12 and 14-23 |
| Device patent |
Covers pump, actuator, or nozzle |
Present through claims 28-29, but tied to formulation |
| Spray-performance patent |
Covers plume or droplet properties |
Central to claims 1, 13, and 26 |
| Method-of-use patent |
Covers treatment indication |
Present through claims 24-25 |
| Manufacturing patent |
Covers preparation process |
Not the principal focus of the supplied claims |
Key Takeaways
- US Patent 10,517,880 is a combination nasal-spray patent for mometasone furoate and olopatadine hydrochloride.
- Its core protection is the combination of an aqueous single-phase suspension and defined spray-performance characteristics.
- Claims 13 and 26 create narrower but commercially important protections based on spray geometry and droplet size.
- The detailed formulation includes 0.025% mometasone furoate monohydrate and 0.665% olopatadine hydrochloride, with sodium carboxymethylcellulose and other excipients.
- The reported expiration date is February 14, 2037.
- The patent is relevant to Ryaltris and its U.S. commercialization by Hikma under rights from Glenmark.
- Generic risk is highest for a product that copies the approved formulation and delivery system.
- Biosimilar risk is not applicable because Ryaltris is a nonbiologic small-molecule combination.
- The principal legal vulnerabilities concern obviousness, enablement, measurement methodology, claim definiteness, and whether spray characteristics are inherent or expected from prior-art devices.
Frequently Asked Questions
Does US Patent 10,517,880 cover olopatadine nasal spray by itself?
No. The claims require mometasone and olopatadine in the same aqueous suspension, along with defined sprayer or spray-performance limitations.
Does the patent cover mometasone furoate nasal spray without olopatadine?
No. The supplied claims require both active ingredients. A mometasone-only product would not literally satisfy the combination limitation.
Can a generic use the same active ingredients with a different nozzle?
Potentially, but the product would still need to avoid the claimed spray-pattern, droplet-size, formulation, and device limitations. A different nozzle does not by itself eliminate infringement.
Is the 25-microgram/665-microgram dose independently patented?
The dose is protected in dependent claims 3 and 26 when combined with the other required sprayer and composition limitations. The dose alone is not the full scope of those claims.
Does FDA approval prove that the patent is valid?
No. FDA approval and Orange Book listing do not adjudicate patent validity, enforceability, infringement, or the outcome of a Paragraph IV challenge.
References
- United States Patent and Trademark Office. (2019). U.S. Patent No. 10,517,880, nasal spray composition comprising mometasone and olopatadine.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (2022). Ryaltris prescribing information.
- U.S. Food and Drug Administration. (n.d.). Hatch-Waxman amendments and abbreviated new drug applications.
- Hikma Pharmaceuticals PLC. (2021). Hikma enters into exclusive U.S. licensing agreement with Glenmark for Ryaltris.
