Details for Patent: 10,561,672

Which drugs does patent 10,561,672 protect, and when does it expire?

Patent 10,561,672 protects RYALTRIS and is included in one NDA.

This patent has seventy-three patent family members in twenty-eight countries.

Summary for Patent: 10,561,672

Title:	Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
Abstract:	The present invention relates to a stable fixed dose aqueous pharmaceutical composition (e.g., contained in a container) for nasal administration to a human, comprising mometasone or its salt, olopatadine or its salt. The composition may further include a hydrocolloid. The invention also relates to a process for preparing the pharmaceutical composition, and the use of the pharmaceutical composition in the treatment of rhinitis in a subject.
Inventor(s):	Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak
Assignee:	Glenmark Specialty SA
Application Number:	US15/703,780
Patent Claim Types: see list of patent claims	Composition; Compound;

US Patent 10,561,672: Claim Scope, Exclusivity, Orange Book Status, and Competitive Landscape

US Patent 10,561,672 protects aqueous fixed-dose nasal suspensions combining mometasone furoate and olopatadine hydrochloride. Its broadest claims require the two active ingredients, micronized mometasone particles, and a hydrocolloid that limits phase separation. Narrower claims add concentration, pH, viscosity, osmolality, particle-size, stability, preservative, buffer, and excipient limitations.

The patent is commercially relevant to Ryaltris, a prescription nasal spray containing mometasone furoate and olopatadine hydrochloride. The principal infringement risk is for generic or follow-on products that copy the same fixed-dose suspension architecture rather than merely products containing the same two active ingredients.

What drug and formulation does US Patent 10,561,672 protect?

The patent covers a suspension for nasal administration in which:

• Mometasone furoate is present as particles with a mean particle size of 1 to 20 micrometers.
• Olopatadine hydrochloride is present as a dissolved or otherwise non-particulate active component.
• A hydrocolloid prevents or delays phase separation.
• Mometasone furoate and olopatadine hydrochloride are the sole active ingredients.
• The formulation is aqueous and intended for human nasal administration.

The claims correspond to the technical problem of combining an insoluble corticosteroid with an antihistamine in a physically stable nasal suspension. The formulation must maintain uniformity during storage and use while delivering both actives through a nasal spray device.

Commercial product relationship

Ryaltris contains:

Component	Ryaltris formulation characteristic
Mometasone furoate	0.025%
Olopatadine hydrochloride	0.6% nominal strength; patent claim 14 specifies 0.665% w/w
Dosage form	Aqueous nasal spray suspension
Therapeutic class	Intranasal corticosteroid plus antihistamine
Reference sponsor	Glenmark Pharmaceuticals
FDA approval	NDA 214697, approved January 2022

The FDA prescribing information identifies mometasone furoate and olopatadine hydrochloride as the active components of Ryaltris. [1]

How are the independent claims structured?

Claims 1, 6, 14, and 22 are independent claims. They create separate infringement routes with materially different breadth.

Claim	Principal scope	Relative breadth
1	Two-active aqueous nasal suspension; 1-20 µm mometasone; hydrocolloid; 24-hour phase-separation limitation	Broadest general composition claim
6	Claim 1 architecture with 0.025-0.05% mometasone and 0.6-0.7% olopatadine	Narrower concentration claim
14	Specific formulation with exact excipient and concentration profile	Narrow, formulation-specific claim
22	Fixed-dose composition with 0.025% mometasone, 0.665% olopatadine, and hydrocolloid	Narrower fixed-dose claim

A product need not infringe every independent claim. Infringement of any valid, enforceable independent claim could support an action, subject to claim construction and product testing.

Claim 1: the broad platform claim

Claim 1 requires five central elements:

1. An aqueous composition.
2. A nasal suspension for human administration.
3. Mometasone furoate particles with a mean size of 1-20 µm.
4. Olopatadine hydrochloride.
5. A hydrocolloid sufficient to inhibit phase separation for at least 24 hours under specified storage conditions.

The claim does not specify a particular hydrocolloid, pH, viscosity, osmolality, active concentration, preservative, buffer, or delivery device. This gives claim 1 its principal blocking potential.

A generic formulation could avoid claim 1 by changing the active ingredient, removing the particulate mometasone suspension architecture, using a different physical form of mometasone, or demonstrating that its composition does not satisfy the phase-separation limitation. Merely changing an excipient may not be enough if the replacement remains a hydrocolloid and performs the claimed stabilization function.

Claim 6: concentration-defined protection

Claim 6 limits the active concentrations to:

• Mometasone furoate: 0.025% to 0.05% by weight.
• Olopatadine hydrochloride: 0.6% to 0.7% by weight.

This range captures the commercial strength of Ryaltris and leaves little concentration flexibility for a directly substitutable generic product. A formulation using 0.025% mometasone and approximately 0.6% olopatadine would face a high literal-infringement risk if it also satisfies the particle-size, hydrocolloid, aqueous-suspension, and stability limitations.

Claim 14: the formulation fingerprint

Claim 14 is substantially narrower. It recites a specific formulation containing:

• 0.025% w/w mometasone furoate monohydrate.
• 0.665% w/w olopatadine hydrochloride.
• 0.5% w/w sodium carboxymethylcellulose.
• 1.2% w/w microcrystalline cellulose and sodium carboxymethylcellulose mixture.
• 0.02% w/w benzalkonium chloride.
• 0.41% w/w sodium chloride.
• 0.01% w/w disodium edetate.
• 0.94% w/w sodium phosphate heptahydrate.
• 0.01% w/w polysorbate 80.
• pH of 3.3 to 4.1.

Claim 14 is vulnerable to a design-around that changes one or more exact excipient concentrations or substitutes a functionally different excipient system. Its value is greatest against products that closely reproduce the branded formulation.

What dependent limitations expand the patent’s technical coverage?

The dependent claims create fallback positions around the most commercially important formulation attributes.

Claims	Limitation
2, 7	Mometasone mean particle size of 1-15 µm
3, 11, 17	pH of 3.3-4.1
12, 19	pH of 3.5-3.9
4, 13	Osmolality of 250-350 mOsm/kg
5, 10	Viscosity of 20-150 cps
8	Mometasone furoate monohydrate
9	Sodium carboxymethylcellulose hydrocolloid
15	Substantially free of olopatadine crystals after three months
16	Substantially free of olopatadine crystals after six months
18, 20	Viscosity of 20-60 cps
21	0.025% mometasone furoate

The particle-size limitations support sprayability, suspension uniformity, and nasal deposition. The pH and osmolality limitations address nasal tolerability and product stability. The viscosity limitations target suspension control without making the spray difficult to administer.

Claims 15 and 16 are particularly important in a formulation dispute because they add a long-term physical-stability characteristic. “Substantially free” is potentially fact-intensive and may require analytical testing, microscopy, or other crystal-detection methods.

What formulation features are protected by US 10,561,672?

The patent protects several overlapping formulation concepts rather than one isolated ingredient combination.

Fixed-dose active combination

The claims require mometasone furoate and olopatadine hydrochloride as the sole active ingredients. This excludes compositions that add another pharmacologically active ingredient, although adding an active ingredient would likely change the product’s regulatory and commercial profile.

Micronized mometasone suspension

The mometasone must be in particulate form within the claimed mean-size range. A product using a dissolved mometasone formulation, a materially different particle-size distribution, or a different corticosteroid could avoid this limitation.

The claim recites mean particle size, not a complete particle-size distribution. This creates potential disputes over:

• Measurement technique.
• Sampling method.
• Whether mean size is volume-, mass-, or number-weighted.
• Whether the test is performed before or after formulation.
• Whether agglomerates are counted as particles.
• Whether the relevant measurement is the active ingredient or the finished suspension.

Hydrocolloid stabilization

The hydrocolloid limitation is broad in composition but specific in performance. Claim 9 identifies sodium carboxymethylcellulose as one covered hydrocolloid. Claim 14 adds both sodium carboxymethylcellulose and a microcrystalline-cellulose/carboxymethylcellulose system.

Potentially relevant hydrocolloids include cellulose derivatives, xanthan gum, carbomers, alginates, and other suspending polymers. Coverage depends on whether the material qualifies as a hydrocolloid under the applicable claim construction and whether it is present in an amount that satisfies the phase-separation test.

Phase-separation performance

The phrase “in an amount sufficient to inhibit phase separation for at least 24 hours” is a functional limitation. The test condition is specified as 25±2° C. and 60±5% relative humidity.

This limitation may require:

• A defined storage protocol.
• A baseline assessment of uniformity.
• A method for identifying phase separation.
• Evidence that the hydrocolloid, rather than another formulation component, supplies the claimed effect.

A generic applicant could seek to avoid the claim by demonstrating that its formulation does not satisfy the stated stability condition. That approach may create a tradeoff: a formulation that separates more rapidly could avoid the patent but face pharmaceutical quality, dosing-uniformity, or regulatory problems.

When does US Patent 10,561,672 lose exclusivity?

The patent issued on February 18, 2020, as US Patent No. 10,561,672. Public patent records identify a priority chain extending to the underlying Glenmark formulation work. The apparent patent-term expiration is in 2034, subject to the recorded priority chain, patent-term adjustment, terminal disclaimers, and any patent-term extension reflected in USPTO records. [2]

Event	Date or status
Patent grant	February 18, 2020
Patent number	US 10,561,672
Product association	Ryaltris, olopatadine hydrochloride/mometasone furoate
Expected term horizon	2034, subject to USPTO term data
FDA approval of Ryaltris	January 2022
Regulatory exclusivity	Three-year NDA exclusivity associated with approval of a new clinical investigation
Generic pathway	ANDA, with Paragraph IV certification possible

The patent term and FDA regulatory exclusivity are separate. FDA approval does not itself establish patent validity, and patent expiration does not eliminate other patents that may cover the product, device, formulation, or method of use.

What is the Orange Book status of US 10,561,672?

The patent has been associated with the Ryaltris NDA in FDA Orange Book patent information. Orange Book listing gives the NDA holder a mechanism to receive notice of certain ANDA certifications and to bring a patent infringement action under the Hatch-Waxman framework. [3]

An Orange Book listing does not establish that every claim is valid or infringed. It identifies patent information submitted for the approved drug. The relevant commercial questions are:

• Whether the patent remains listed for the applicable NDA.
• Whether an ANDA applicant certifies Paragraph I, II, III, or IV.
• Whether the NDA holder files suit within the statutory period after Paragraph IV notice.
• Whether litigation triggers a 30-month stay.
• Whether the product is subject to a settlement or licensed launch date.

The FDA Orange Book should be checked against the current NDA listing because patent listings and regulatory records can change over time. [3]

What Paragraph IV challenges and litigation affect the patent?

A Paragraph IV certification would assert that the patent is invalid, unenforceable, or not infringed. The ANDA applicant would need to address the listed patent while seeking approval for a generic version of the reference product.

Potential litigation issues include:

Issue	Likely dispute
Particle size	Whether the accused mometasone has a mean size within 1-20 µm or 1-15 µm
Hydrocolloid status	Whether the chosen polymer is a hydrocolloid
Phase separation	Whether the product satisfies the 24-hour functional limitation
Active concentration	Whether concentrations fall within the claimed ranges
Monohydrate form	Whether the mometasone is mometasone furoate monohydrate
pH and viscosity	Whether measured values fall within dependent claims
Sole active ingredients	Whether another pharmacologically active component is present
Crystal limitation	Whether the product is substantially free of olopatadine crystals after storage

The strongest litigation position would usually come from claims 1, 6, or 22 because they map to the core product architecture and commercial strengths. Claim 14 is more specific and may be easier to avoid through excipient or concentration changes, although it may provide a strong claim against a close copy.

No biosimilar pathway applies. Ryaltris is a small-molecule drug, not a biologic. A competing product would generally proceed through an ANDA or, for a materially different formulation, a 505(b)(2) application rather than a biosimilar application.

How strong is the patent estate for Ryaltris?

US 10,561,672 is technically significant because it combines composition, physical-property, and stability limitations. Its strength is mixed across claim categories.

Strength factor	Assessment
Product relevance	High; claims track the commercial two-active nasal suspension
Breadth of claim 1	Moderate to high
Breadth of claim 14	Low to moderate because of exact excipients and amounts
Design-around potential	Moderate
Detectability of infringement	Moderate; requires formulation and analytical testing
Stability limitation	Potentially strong but method-dependent
Regulatory leverage	High if currently Orange Book listed
Invalidity exposure	Dependent on prior art and written-description support

The main invalidity risks would involve obviousness and written description. A challenger could argue that combining known intranasal mometasone and olopatadine products, with conventional suspending agents and routine pH or viscosity optimization, would have been obvious. The patent holder would likely rely on unexpected stability, reduced olopatadine crystallization, suspension uniformity, or clinically acceptable nasal delivery.

The most defensible claims are likely the claims that connect the specific formulation architecture to demonstrated stability results. The broad functional language in claim 1 creates commercial coverage but may face greater scrutiny if the specification does not support the full range of hydrocolloids, particle sizes, and formulations.

What generic launch scenarios exist?

Scenario 1: Paragraph IV challenge and immediate litigation

An ANDA applicant could challenge US 10,561,672 before expiration. A timely infringement action could trigger the statutory 30-month stay, delaying approval unless the court resolves the case earlier or the stay is otherwise terminated.

Scenario 2: Paragraph III certification

The applicant could accept the patent and defer commercial launch until patent expiration or an agreed earlier date. This approach reduces litigation exposure but delays market entry.

Scenario 3: Formulation design-around

A competitor could alter:

• Mometasone concentration.
• Olopatadine concentration.
• Particle-size profile.
• Hydrocolloid identity or amount.
• pH.
• Viscosity.
• Preservative system.
• Buffer system.
• Mometasone solid form.

The design must still meet FDA requirements for dose uniformity, stability, spray performance, microbial quality, and clinical or bridging requirements.

Scenario 4: 505(b)(2) product

A materially different formulation or delivery system could use a 505(b)(2) pathway. This may reduce reliance on the Ryaltris formulation but could create separate clinical, labeling, device, and patent issues.

How does US 10,561,672 compare with ordinary single-ingredient nasal sprays?

Attribute	US 10,561,672 combination product	Conventional single-ingredient spray
Active ingredients	Mometasone plus olopatadine	One corticosteroid or antihistamine
Physical form	Aqueous suspension	Solution or suspension
Core technical issue	Compatibility and physical stability of two actives	Stability of one active
Particle-size limitation	Expressly claimed for mometasone	May not be claimed in the same way
Hydrocolloid requirement	Central to independent claims	Product-specific
Generic substitution	Must reproduce combination performance	Usually simpler active-ingredient substitution
Regulatory pathway	ANDA or 505(b)(2)	Usually ANDA if therapeutically equivalent

The patent does not broadly block every nasal product containing mometasone or every product containing olopatadine. Its blocking position depends on the simultaneous presence of both actives in the claimed aqueous suspension structure.

What geographic coverage does the patent provide?

US 10,561,672 provides protection only in the United States. Parallel patent family members may exist in other jurisdictions, but foreign rights must be evaluated independently for:

• National-phase status.
• Claim scope.
• Patent-term calculation.
• Opposition or invalidation proceedings.
• Supplementary protection certificates.
• Local regulatory linkage rules.
• Local generic-launch requirements.

A US design-around does not establish freedom to operate in Europe, Canada, Japan, Australia, or other markets. Conversely, expiration or invalidation of a foreign counterpart does not affect the US patent.

What manufacturing and intellectual-property barriers remain?

The patent is directed primarily to composition and performance, but manufacturing can create practical barriers even where a competitor avoids literal infringement.

Important process controls include:

• Micronization of mometasone furoate.
• Control of crystal form and hydration state.
• Prevention of agglomeration.
• Uniform incorporation of the hydrocolloid.
• Control of viscosity and redispersibility.
• Maintenance of spray-pump dose uniformity.
• Prevention of olopatadine crystallization.
• Compatibility with benzalkonium chloride and polysorbate 80.
• Control of pH and osmolality during storage.

A competitor may avoid claim 14 by changing excipient concentrations yet still face separate patents covering manufacturing, device components, spray actuation, or alternative formulations. A complete freedom-to-operate review must therefore extend beyond US 10,561,672 and include the complete patent family and any later Ryaltris-related filings.

Key Takeaways

• US 10,561,672 protects an aqueous nasal suspension combining mometasone furoate and olopatadine hydrochloride.
• Claim 1 is the principal broad composition claim.
• Claim 6 targets the commercial concentration ranges.
• Claim 14 covers a highly specific formulation fingerprint associated with the branded product.
• Claims 15 and 16 add olopatadine-crystal stability limitations after three and six months.
• The patent is relevant to Ryaltris and has been associated with its FDA regulatory listing.
• Generic developers face the greatest risk when reproducing the same two-active suspension, micronized mometasone, hydrocolloid stabilization system, and commercial concentrations.
• Design-around options exist, but changes must preserve nasal spray quality, dose uniformity, stability, and regulatory acceptability.
• The expected patent-term horizon is 2034, subject to the USPTO-recorded term calculation and any applicable adjustments.
• No biosimilar pathway applies because Ryaltris is a small-molecule drug.

FAQs About US Patent 10,561,672

Does US 10,561,672 cover mometasone nasal sprays without olopatadine?

No. The independent claims require olopatadine hydrochloride as a second active ingredient. A mometasone-only nasal spray would not satisfy that required element.

Does changing olopatadine hydrochloride to olopatadine free base avoid the claims?

Potentially, but the outcome depends on claim construction, product composition, and whether the accused material is legally treated as olopatadine hydrochloride. The claims expressly recite olopatadine hydrochloride.

Can a generic avoid the patent by using a solution instead of a suspension?

A true aqueous solution would not satisfy the suspension limitation. The formulation would still need to meet FDA requirements for solubility, stability, dose uniformity, nasal deposition, and therapeutic equivalence.

Is a product with 0.6% olopatadine outside claim 14?

Not necessarily. Claim 14 recites 0.665% olopatadine, but claims 1, 6, and 22 may create separate exposure depending on the exact formulation and applicable claim interpretation.

Does the patent cover a nasal device?

The quoted claims are composition claims. They do not expressly require or claim a particular nasal spray pump, container, actuator, or device configuration.

References

1. U.S. Food and Drug Administration. (2022). Ryaltris prescribing information: Olopatadine hydrochloride and mometasone furoate nasal spray.

2. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,561,672, pharmaceutical composition. Washington, DC: U.S. Department of Commerce.

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. Washington, DC: U.S. Department of Health and Human Services.

Drugs Protected by US Patent 10,561,672

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	10,561,672		Y

Foreign Priority and PCT Information for Patent: 10,561,672

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2975/MUM/2013	Sep 13, 2013

International Family Members for US Patent 10,561,672

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