Details for Patent: 11,679,210

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Which drugs does patent 11,679,210 protect, and when does it expire?

Patent 11,679,210 protects RYALTRIS and is included in one NDA.

This patent has one hundred and eight patent family members in thirty-five countries.

Summary for Patent: 11,679,210

Title:	Dispensing device and pharmaceutical composition for the treatment of rhinitis
Abstract:	A nasal dispensing device and pharmaceutical composition includes a container; a dispenser head having at least a pump, a dispensing channel, and a dispensing orifice; a dip tube; and a pharmaceutical composition comprising mometasone, an ester thereof (e.g., mometasone furoate), or a salt thereof and olopatadine or its salt (e.g., olopatadine hydrochloride). The container can have a conically shaped internal bottom, angled downwardly toward a center, and a further angularly deepened well, centrally located, with the dip tube extending into the well. An optional cap is provided that includes a sealing sleeve communicating in a seal tight manner with a perimeter of a lateral wall of the dispenser head.
Inventor(s):	Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak, Neelima Khairatkar-Joshi, Abhay Kulkarni, Dinesh Pradeep WALE, Vikram Mansingh BHOSALE, Piyush Agarwal, Patrick Keohane, Sudeesh K. TANTRY, Chad OH
Assignee:	Glenmark Specialty SA
Application Number:	US16/303,609
Patent Claim Types: see list of patent claims	Composition; Compound; Device;

US Patent 11,679,210: Claim Scope, Ryaltris Patent Landscape, Exclusivity and Generic Risk

US Patent 11,679,210 protects a combination of three elements: a nasal dispensing device with a low-point well and transverse groove, a sealed dispensing cap, and a single-phase nasal suspension containing particulate mometasone and dissolved olopatadine. The patent is directed to the product configuration associated with the mometasone furoate/olopatadine hydrochloride nasal spray marketed as Ryaltris.

The broadest commercial risk is not limited to copying the drug formulation. A competing product may infringe through the container geometry, dip-tube placement, cap seal, formulation ranges, or the combined device-and-composition claims. Claims 1 and 9 create two alternative container structures, while claim 10 combines the device, cap, and single-phase suspension limitations in a separate independent claim.

What does US Patent 11,679,210 protect?

The patent protects a nasal spray system rather than a composition standing alone. Each independent claim requires a dispensing device and a pharmaceutical composition in the device.

Independent claim	Principal protected subject matter	Key limitations
Claim 1	Device and composition	Conical internal bottom, central well, transverse groove, dip tube reaching groove, mometasone, olopatadine and hydrocolloid
Claim 9	Device and composition with external support bead	Groove extends deeper than the well wall thickness and modifies the external bottom
Claim 10	Device, sealed cap and single-phase suspension	Grooved low-point well, sealed cap sleeve, single-phase suspension, mometasone, olopatadine and hydrocolloid system

The claims are unusually integrated. A challenger generally must analyze both the container architecture and the formulation. A formulation that falls within the claimed concentration ranges may avoid infringement if sold in a materially different container. Conversely, a device that copies the well-and-groove structure may still avoid the independent claims if the formulation does not satisfy the active-ingredient or hydrocolloid limitations.

How broad are the mometasone and olopatadine formulation claims?

The formulation ranges are commercially significant:

Component	Claimed range or requirement
Mometasone, ester or salt	About 0.001% to about 0.075% w/w, in particulate form
Olopatadine or salt	About 0.5% to about 0.8% w/w, in dissolved form
Hydrocolloid	Amount sufficient to inhibit phase separation for at least 24 hours at 25±2°C and 60%±5% relative humidity
Impurities	Not more than 1% total impurities for up to 12 months, under claim 3
Dose volume	About 100 microliters per actuation
Olopatadine dose	About 665 micrograms per actuation
Mometasone dose	About 25 or 50 micrograms per actuation
pH	About 3.3 to 4.1 under claim 15
Osmolality	About 200 to 400 mOsm/kg under claim 15

Claim 1 uses “mometasone, an ester thereof, or a salt thereof,” while claim 8 narrows the formulation to mometasone furoate and olopatadine hydrochloride. The composition in claim 8 also identifies specific excipient concentrations:

• 0.5% w/w sodium carboxymethylcellulose;
• 1.2% w/w microcrystalline cellulose and sodium carboxymethylcellulose mixture;
• 0.02% w/w benzalkonium chloride;
• 0.4% w/w sodium chloride;
• 0.01% w/w disodium edetate;
• 0.94% w/w sodium phosphate heptahydrate; and
• 0.01% w/w polysorbate 80.

The independent claims do not require the exact claim 8 excipient package. A product may therefore fall within claims 1, 9 or 10 without matching every excipient or concentration in claim 8, provided the hydrocolloid and active-ingredient limitations are met.

What technical problem does the grooved container solve?

The container claims address residual product and dose recovery during use. A conventional nasal-spray bottle with a flat or sloped bottom may leave suspension at the perimeter or below the dip-tube inlet. The claimed design directs liquid toward a central low point.

The relevant geometry has four parts:

1. A conical internal bottom slopes from the container wall toward the center.
2. A central well is angularly deeper than the surrounding bottom.
3. A groove crosses the longitudinal axis within the well.
4. The dip-tube opening reaches the groove or its upper edge.

This structure is intended to place the remaining formulation at the dip-tube inlet as the container empties. The patent therefore combines formulation stability with physical recovery of a suspension that may contain particulate corticosteroid.

Claim 2 covers a groove that remains within the bottom wall thickness and does not alter the external bottom. Claim 9 covers the opposite structure, where the groove extends deeper than the wall thickness and requires an external support bead. The claims thus create alternative protection for two manufacturing configurations.

What formulations are protected by US 11,679,210?

The clearest formulation embodiment is the composition recited in claim 8:

Ingredient	Approximate concentration
Mometasone furoate	0.025% w/w
Olopatadine hydrochloride	0.665% w/w
Sodium carboxymethylcellulose	0.5% w/w
Microcrystalline cellulose/sodium carboxymethylcellulose mixture	1.2% w/w
Benzalkonium chloride	0.02% w/w
Sodium chloride	0.4% w/w
Disodium edetate	0.01% w/w
Sodium phosphate heptahydrate	0.94% w/w
Polysorbate 80	0.01% w/w

The formulation is a suspension because mometasone is present in particulate form. Olopatadine is dissolved. The hydrocolloid system, including cellulose-based excipients, is used to inhibit phase separation.

This distinction matters in a generic-development review. A formulation containing dissolved mometasone would not literally satisfy the particulate-mometasone limitation. A product containing particulate olopatadine may not satisfy the dissolved-olopatadine limitation. A developer must also evaluate whether an alternative suspending agent is equivalent to the claimed hydrocolloid system under the doctrine of equivalents.

Which claims cover the cap and sealing structure?

Claims 5, 6, and 10 through 14 address the cap and dispenser-head interface.

The cap includes an internal sealing sleeve that contacts the perimeter of the dispenser head's lateral wall. Claim 6 requires the sleeve's distal inner diameter to be smaller than the exterior diameter of the dispenser-head wall at the contact point. Closing the cap radially deforms the sleeve and creates a seal.

Claim 13 narrows the structure by requiring the sleeve wall to become thinner as it extends away from the cap's top inside wall. Claim 14 adds internal tabs that snap against the dispenser head and hold the cap closed.

These claims may have independent design-around value. A competitor could investigate:

• an external plug seal rather than a sleeve around the lateral wall;
• a cap that seals directly against the dispensing orifice;
• a sleeve with a constant wall thickness;
• threaded retention rather than snap-fit tabs; or
• a dispenser head with a different external profile.

A design-around must still be assessed against the independent claim language and potential equivalents. Altering the cap alone may not avoid claims 1 or 9 if the same grooved container and formulation are used.

How does the patent claim the marketed dose?

Claims 4 and 16 recite a 100-microliter actuation delivering approximately 665 micrograms of olopatadine hydrochloride and approximately 25 or 50 micrograms of mometasone furoate.

The 0.665% w/w olopatadine hydrochloride concentration corresponds closely to a 665-microgram amount in a 100-microliter dose, subject to density and formulation measurement conventions. The 0.025% w/w mometasone furoate concentration corresponds to approximately 25 micrograms per 100 microliters.

These dose limitations strengthen the product-specific nature of the claims but may also create noninfringement opportunities. A product with a materially different metered volume, active concentration, or delivered dose could fall outside claims 4 and 16 while remaining exposed under the broader independent claims.

What is the FDA and Orange Book status of the product associated with this patent?

The active-ingredient combination is olopatadine hydrochloride and mometasone furoate. The branded nasal spray Ryaltris was approved by the FDA for treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients aged 12 years and older, according to FDA labeling.[2]

Regulatory item	Status
Product	Ryaltris
Active ingredients	Olopatadine hydrochloride and mometasone furoate
Dosage form	Metered nasal spray
Route	Intranasal
FDA pathway	New Drug Application
Indication	Seasonal allergic rhinitis
Typical metered volume	100 microliters per spray
Patent relevance	Device, formulation and dose configuration

FDA Orange Book treatment depends on whether a patent is submitted for listing and whether it claims the approved drug, formulation, method of use, or an approved device component under applicable FDA rules.[3] The claims supplied for US 11,679,210 are combination claims. They do not establish, by themselves, whether the patent is currently listed in the Orange Book, the listed use code, or the date on which any patent listing expires.

The patent's issue date was June 27, 2023, based on the patent number and public USPTO bibliographic record. Patent expiration cannot be determined from the issue date alone. It depends on the earliest effective nonprovisional priority date, terminal disclaimers, patent-term adjustment, and any patent-term extension. The statutory framework generally provides a 20-year term measured from the earliest effective US nonprovisional filing date, subject to those adjustments.[4]

When does US Patent 11,679,210 lose exclusivity?

The patent does not lose exclusivity on its issue date plus 20 years. The relevant calculation is:

Term factor	Effect
Earliest effective US nonprovisional filing date	Establishes the base 20-year term
Patent-term adjustment	May extend the term for USPTO examination delays
Terminal disclaimer	May shorten the term to match another patent
Patent-term extension	May extend the term for qualifying regulatory review
Continuation or divisional status	Usually retains the parent application's effective filing date
PTA and PTE records	Must be checked in the official USPTO and FDA records

A precise expiration date is therefore a legal-record question rather than a calculation from the patent number. The claims supplied do not include the priority chain, terminal disclaimer status, patent-term adjustment, or patent-term extension.

FDA regulatory exclusivity is separate from patent exclusivity. Ryaltris approval may create regulatory protections under the NDA framework, but those protections do not necessarily expire on the same date as US 11,679,210.[2,3]

What Paragraph IV challenges and generic entry risks exist?

A generic or follow-on applicant using an ANDA could challenge listed patents through a Paragraph IV certification if the relevant patent is listed for the reference product. A Paragraph IV notice would typically trigger a 45-day period for the patent owner or NDA holder to file an infringement action. A timely suit can impose a 30-month stay on final FDA approval, subject to statutory exceptions and court developments.[5]

The principal generic entry scenarios are:

Entry scenario	Exposure under US 11,679,210
Same formulation and same grooved container	High literal-infringement risk
Same formulation, redesigned container	Claims 1, 9 and 10 may be avoided if device limitations are absent
Similar container, different active concentrations	May avoid concentration and dose limitations
Different suspending system	Requires analysis of hydrocolloid and equivalents
Different cap seal, same container and formulation	Cap-dependent claims may be avoided, but independent claims remain relevant
Alternative nasal device with no dip tube	Likely reduces literal exposure to the device claims
505(b)(2) product with modified formulation or device	Patent certifications and litigation exposure remain product-specific

Because the patent claims the combination, a developer should not assume that a formulation-only ANDA review captures the entire risk. The device supplier's drawings, dip-tube dimensions, container bottom geometry, cap tolerances and assembly specifications may be central to infringement analysis.

How strong is the patent estate for Ryaltris?

US 11,679,210 has meaningful commercial scope but a narrower literal footprint than a conventional composition patent.

Strengths

• It covers a defined commercial formulation with a 100-microliter dose.
• It claims both active ingredients in different physical states.
• It covers the stabilizing hydrocolloid function, not merely a named excipient.
• It protects two distinct bottom-groove configurations.
• It reaches the device and formulation in the same claim.
• Dependent claims add pH, osmolality, impurity and cap-seal limitations.

Weaknesses and possible invalidity pressure points

• The claims require a specialized container geometry that may not be used by all competitors.
• “About” ranges can generate claim-construction disputes at the boundaries.
• The hydrocolloid limitation requires a functional stability result that may raise testing and reproducibility issues.
• The claim combines device and formulation limitations, potentially narrowing infringement.
• Prior art may exist for nasal suspensions containing corticosteroids, antihistamines, cellulose hydrocolloids, grooved containers and dip tubes.
• The specification must support the full breadth of the claimed active-ingredient ranges and alternative salts or esters under written-description and enablement standards.
• The single-phase suspension language in claim 10 may invite disputes over the meaning of “single phase” for a formulation containing particulate mometasone.

The patent is strongest against a copycat product that reproduces the Ryaltris formulation and the specified container. It is weaker against a product that uses a different delivery system or materially different formulation architecture.

Which companies are positioned to challenge the product?

The relevant competitive group includes generic pharmaceutical companies with intranasal spray manufacturing capabilities, nasal-pump suppliers, and companies pursuing 505(b)(2) products.

Potential entrants would likely evaluate:

• olopatadine/mometasone combination products;
• separate olopatadine and mometasone nasal sprays;
• alternative fixed-dose allergy sprays;
• different suspension vehicles;
• preservative-free nasal devices; and
• non-identical pump and container systems.

The market also includes established intranasal allergy products such as Patanase, Nasonex, Dymista and generic versions of olopatadine or mometasone products. These products are competitive substitutes but do not necessarily practice the combination claims of US 11,679,210.

Biosimilar risk is not material. Mometasone and olopatadine are small-molecule active ingredients, not biologics. The relevant challenge pathways are ANDA and, for materially modified products, 505(b)(2), rather than a biosimilar application under the Public Health Service Act.

What litigation and settlement issues should be monitored?

The supplied claims do not identify a complaint, Paragraph IV notice, settlement agreement, consent judgment or appellate decision involving US 11,679,210. Litigation surveillance should focus on:

1. FDA Orange Book patent-listing records for the Ryaltris NDA.
2. Paragraph IV notices concerning olopatadine/mometasone nasal sprays.
3. District Court filings naming the patent, NDA holder or product manufacturer.
4. Any terminal disclaimer or continuation-family litigation.
5. ANDA approval dates and 30-month-stay orders.
6. Settlement terms involving licensed generic entry, launch dates or supply restrictions.

A settlement can materially change the commercial value of the patent without changing its nominal expiration date. A licensed entry date may become the practical endpoint for market exclusivity.

What manufacturing and geographic IP barriers exist?

The container claims create a manufacturing barrier separate from the active pharmaceutical ingredient. A challenger may need new tooling for:

• the conical internal bottom;
• the central well;
• the transverse groove;
• the external support bead in the claim 9 configuration;
• the dip-tube length and alignment; and
• the cap's radially deformable sealing sleeve.

These features may require injection-molding changes, dimensional validation, dose-delivery testing and extractables/leachables work. A noninfringing design may therefore carry regulatory and supply-chain costs even if technically feasible.

The patent is a US right. It does not by itself block manufacture or sale outside the United States. Foreign counterparts, national-phase filings and local expiration dates must be reviewed separately. A US design-around may remain exposed in Europe, Canada, Japan or other jurisdictions if corresponding family patents claim the same formulation or device.

Key Takeaways

• US 11,679,210 protects a nasal spray combination of mometasone, olopatadine and a hydrocolloid-stabilized suspension in a specialized container.
• Claims 1, 9 and 10 are the core infringement claims.
• The container's central well, transverse groove and dip-tube position are central limitations.
• Claim 8 identifies a formulation closely associated with Ryaltris.
• Claims 4 and 16 protect a 100-microliter dose delivering 665 micrograms of olopatadine and 25 or 50 micrograms of mometasone.
• Claims 5, 6 and 11 through 14 protect cap sealing and retention structures.
• Generic risk is highest for a product that copies both the commercial formulation and the grooved container.
• A different pump, container bottom, cap, active concentration or hydrocolloid system may provide design-around opportunities.
• Biosimilar competition is not relevant because both active ingredients are small molecules.
• The patent's exact expiration date requires review of its priority chain, PTA, terminal disclaimers and any PTE.
• Orange Book listing, Paragraph IV activity and settlement status must be determined from current FDA and court records, not from the claim text alone.

FAQs About US Patent 11,679,210

Does US 11,679,210 claim mometasone and olopatadine by themselves?

No. The independent claims require the active ingredients in a dispensing device with specified container geometry and dip-tube placement. The patent is not limited to a composition-only claim.

Can a generic avoid the patent by changing only the cap?

Possibly for cap-dependent claims, but not necessarily for claims 1 or 9. Those claims do not require every cap limitation. The container geometry, dip tube and formulation would remain independently relevant.

Does the patent cover a liquid solution of mometasone?

The claims require mometasone in particulate form. A fully dissolved mometasone formulation would present a strong noninfringement argument for that limitation, subject to formulation characterization and equivalents analysis.

Is Ryaltris protected by biologic exclusivity?

No. Ryaltris contains small-molecule active ingredients. Its regulatory and patent issues arise under NDA, Orange Book, ANDA and potentially 505(b)(2) frameworks.

What is the most important design-around feature?

The most consequential design-around target is the container-and-dip-tube structure. A product using a different internal bottom, no central groove, or a dip tube that does not extend into the claimed groove may reduce literal exposure, although the formulation claims and equivalents must still be evaluated.

References

1. United States Patent and Trademark Office. (2023). US Patent No. 11,679,210.
2. U.S. Food and Drug Administration. (2022). Ryaltris prescribing information.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. United States Code, 35 U.S.C. §§ 154, 156.
5. United States Code, 21 U.S.C. § 355(j).

Drugs Protected by US Patent 11,679,210

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	11,679,210		Y

International Family Members for US Patent 11,679,210

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3043773		CA 2021 00050	Denmark
European Patent Office	3043773		301154	Netherlands
European Patent Office	3043773		122021000085	Germany