Details for Patent: 9,750,754

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Which drugs does patent 9,750,754 protect, and when does it expire?

Patent 9,750,754 protects RYALTRIS and is included in one NDA.

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

Summary for Patent: 9,750,754

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:	US15/183,534
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 9,750,754: Scope, Claims, Expiration, and Patent Landscape for Mometasone-Olopatadine Nasal Compositions

U.S. Patent No. 9,750,754 protects specific intranasal combinations of mometasone and olopatadine, particularly aqueous fixed-dose sprays using particulate mometasone, dissolved olopatadine, and cellulose-based viscosity or suspension systems. The patent is closely aligned with the formulation later commercialized as Ryaltris, which contains mometasone furoate and olopatadine hydrochloride at 50 mcg and 665 mcg per spray, respectively.[1][2]

The strongest commercial coverage is concentrated in four areas:

1. Methods of treating allergic rhinitis with the combination.
2. Aqueous formulations containing defined concentration ranges of both active ingredients.
3. Phase-separation control using hydrocolloids, particularly sodium carboxymethyl cellulose.
4. Suppression of olopatadine hydrochloride crystallization.

The patent does not broadly claim all mometasone-olopatadine products. Its scope depends on concentration, physical state, excipient selection, pH, particle size, viscosity, osmolality, and stability characteristics.

What does U.S. Patent 9,750,754 cover?

The patent has six principal independent claims: claims 1, 9, 17, 25, 29, 39, and 47. Claims 1, 9, and 17 are treatment-method claims. Claims 25, 29, 39, and 47 are composition claims or formulation-specific treatment claims.

Claim group	Claim type	Principal subject matter
1-8	Method of treatment	Allergic rhinitis treated with fixed-dose aqueous mometasone and olopatadine
9-16	Method of treatment	Seasonal allergic rhinitis
17-24	Method of treatment	Perennial allergic rhinitis
25-28	Narrow formulation and treatment	Specific Ryaltris-type formulation
29-38	Composition	Mometasone, olopatadine, cellulose derivatives, and excipients
39-46	Composition	Olopatadine hydrochloride formulation substantially free of crystals
47-51	Composition	Sodium carboxymethyl cellulose formulation with defined pH and stability

The patent therefore combines use claims with formulation claims. A company could potentially infringe without practicing the claimed treatment method if it makes, imports, offers for sale, or sells a composition covered by an enforceable composition claim.

What are the key technical limitations in the independent claims?

Claims 1, 9, and 17: combination treatment claims

The treatment claims require all of the following:

• Intranasal administration.
• A fixed-dose aqueous pharmaceutical composition.
• Mometasone or a salt at 0.001% to 0.075% by weight.
• Mometasone in particulate form.
• Olopatadine or a salt at 0.5% to 0.8% by weight.
• Olopatadine in dissolved form.
• A hydrocolloid.
• Stability for at least 24 hours at approximately 25°C and 60% relative humidity.

Claims 9 and 17 narrow the disease indication to seasonal and perennial allergic rhinitis, respectively. Claim 1 covers allergic rhinitis generally.

The “fixed dose” limitation distinguishes a single composition containing predetermined amounts of both active ingredients from separate administration of two nasal products. A two-bottle regimen using separate mometasone and olopatadine products would not ordinarily satisfy the fixed-dose-composition requirement.

The particulate-versus-dissolved distinction is central. Mometasone is present as suspended particles, while olopatadine is dissolved in the aqueous phase. A formulation in which both ingredients are fully dissolved, or in which olopatadine is materially crystallized, presents a stronger non-infringement position against these limitations.

Claim 25: narrow commercial formulation claim

Claim 25 covers a formulation containing:

• 0.025% or 0.05% mometasone furoate monohydrate.
• 0.665% olopatadine hydrochloride.
• 0.5% sodium carboxymethyl cellulose.
• 1.2% microcrystalline cellulose and sodium carboxymethyl cellulose mixture.
• 0.02% benzalkonium chloride.
• 0.41% sodium chloride.
• 0.01% disodium edetate.
• 0.01% polysorbate 80.
• A pH of 3.3 to 4.1.

This is the most product-specific claim set in the patent. It tracks the core formulation architecture described in the FDA labeling for Ryaltris.[2] The claim covers either 0.025% or 0.05% mometasone furoate, but the marketed nasal spray strength is generally expressed by delivered dose rather than by the percentage in the bulk suspension.

Because claim 25 recites a closed list of named ingredients in specified quantities, it is narrower than claim 29 or claim 47. A competing product that uses a different preservative, buffer, surfactant, suspension system, or sodium chloride concentration could avoid claim 25 while remaining within broader claims.

Claims 29 and 39: composition claims

Claim 29 requires:

• Mometasone or a salt at 0.001% to 0.075%.
• Olopatadine or a salt at 0.5% to 0.8%.
• One or more cellulose derivatives.
• One or more additional excipients.

Claim 30 identifies phase-separation suppression as a functional characteristic of the cellulose derivatives. Claim 31 adds the 24-hour stability condition at approximately 25°C and 60% relative humidity.

Claim 39 covers:

• Mometasone or a salt at 0.001% to 0.075%.
• Olopatadine hydrochloride at 0.5% to 0.8%.
• A composition substantially free of olopatadine hydrochloride crystals.

Claim 39 does not expressly require a hydrocolloid or cellulose derivative. It can therefore reach a different formulation design if the product satisfies the concentration and crystallization limitations.

Claim 46 narrows the crystallization limitation to less than 2% crystalline olopatadine hydrochloride based on the total olopatadine hydrochloride weight.

Claim 47: sodium carboxymethyl cellulose formulation

Claim 47 requires:

• Mometasone or a salt at 0.001% to 0.075%.
• Olopatadine or a salt at 0.5% to 0.8%.
• 0.1% to 3% sodium carboxymethyl cellulose.
• One or more additional excipients.
• A pH of 3.3 to 4.1.

Claims 48 through 50 narrow this coverage by specifying:

• Sodium carboxymethyl cellulose at 0.15% to 0.75%.
• Viscosity of 10 to 150 centipoise.
• Suppression of phase separation for at least 24 hours at 25±2°C and 60±5% relative humidity.

Claim 47 is commercially important because it does not require the full excipient package recited in claim 25. A competing product could therefore infringe claim 47 even if it avoids the precise benzalkonium chloride, sodium chloride, edetate, polysorbate, or microcrystalline cellulose quantities in claim 25.

What formulation characteristics are protected?

The dependent claims create a multidimensional limitation set.

Formulation attribute	Claimed range or requirement
Mometasone concentration	0.001% to 0.075% w/w
Olopatadine concentration	0.5% to 0.8% w/w
Mometasone physical state	Particulate
Olopatadine physical state	Dissolved
Active-ingredient weight ratio	1:3 to 1:106
Mometasone particle size	1 to 20 micrometers
pH	3.3 to 4.1
Osmolality	200 to 400 mOsm/kg
Viscosity	10 to 150 cps
Hydrocolloid	At least 0.1% w/w in treatment claims
Sodium carboxymethyl cellulose	0.1% to 3% w/w in claim 47
Crystalline olopatadine	Less than 2% in claim 46
Stability	At least 24 hours under specified temperature and humidity conditions

The ratio limitation is broad enough to encompass the commercial 50 mcg/665 mcg delivered-dose relationship. The claimed range is not limited to one dose strength, but the product must satisfy both concentration ranges and any applicable formulation limitations.

How does the patent cover Ryaltris?

Ryaltris is the closest commercial reference product. The FDA-approved product combines mometasone furoate, a corticosteroid, with olopatadine hydrochloride, an antihistamine, in a nasal spray for allergic rhinitis.[2]

The product’s disclosed delivered dose is 50 mcg of mometasone furoate and 665 mcg of olopatadine hydrochloride per spray. The formulation includes cellulose-based suspension and viscosity-control materials, preservatives, sodium chloride, a chelating agent, and a surfactant.[2]

Ryaltris characteristic	Relationship to Patent 9,750,754
Fixed-dose nasal spray	Directly aligned with claims 1, 9, 17, 25, 29, and 47
Mometasone furoate	Expressly recited in dependent claims
Olopatadine hydrochloride	Expressly recited in claims 3, 11, 19, 25, 34, 39, and 41
Aqueous suspension	Consistent with the treatment and composition claims
Cellulose-based excipients	Relevant to claims 29-38 and 47-50
Phase-separation control	Relevant to claims 30, 31, and 50
pH-controlled formulation	Relevant to claims 5, 13, 21, 25, 36, 43, and 47
Particle-size limitation	Relevant to claims 4, 12, 20, and 26
Seasonal allergic rhinitis	Covered by claims 9-16
Perennial allergic rhinitis	Covered by claims 17-24

The patent is therefore best understood as a formulation and method-of-use patent directed to the technical problem of combining a poorly water-soluble corticosteroid suspension with dissolved olopatadine in one stable nasal product.

When does U.S. Patent 9,750,754 lose exclusivity?

U.S. Patent 9,750,754 issued on September 5, 2017. Its ordinary patent term is generally calculated from the earliest effective nonprovisional filing date under the Uruguay Round Agreements Act framework, not from the issue date.[3]

The exact expiration date requires review of:

• The earliest effective nonprovisional or international filing date.
• Any patent-term adjustment.
• Any patent-term extension.
• Terminal disclaimers.
• Continuation or divisional relationships.

The patent’s base term is expected to fall in the 2033-2034 period, subject to the USPTO’s official patent-term calculation. The issue date alone does not establish the expiration date. Patent-term adjustment can move the expiration date beyond the nominal 20-year term, while a terminal disclaimer can limit it.

A commercial exclusivity analysis should therefore use the USPTO Patent Center term data and the FDA Orange Book listing for the relevant approved product.[3][4]

What is the Orange Book status of Patent 9,750,754?

The Orange Book analysis must distinguish patent ownership from FDA listing. A patent may cover a product but not be listed for a particular NDA. Conversely, an Orange Book-listed patent may cover only an approved method of use or a specific formulation aspect.

For Ryaltris, the relevant regulatory questions are:

• Whether U.S. Patent 9,750,754 is listed against the Ryaltris NDA.
• Whether the listing covers the drug substance, drug product, or method of use.
• Whether the listing has an expiration date reported by FDA.
• Whether the patent is still active or has been delisted.
• Whether later patents in the same family are also listed.

The Orange Book, rather than the patent document alone, controls the FDA’s listed-patent status.[4] The claims supplied for analysis indicate broad overlap with the commercial formulation, particularly claims 25, 29, 39, and 47. That overlap does not by itself establish that every claim is listed against the NDA or that every listed claim is enforceable.

Which companies are likely to challenge the patent?

Generic nasal-spray manufacturers are the principal potential challengers. Relevant companies in the broader nasal-allergy market include:

• Apotex.
• Teva Pharmaceuticals.
• Hikma Pharmaceuticals.
• Amneal Pharmaceuticals.
• Cipla.
• Glenmark competitors in the generic respiratory market.
• Other manufacturers with suspension nasal-spray manufacturing capability.

A Paragraph IV challenger would need to address both patent validity and infringement. The most likely grounds would include:

• Obviousness based on separate mometasone and olopatadine nasal products.
• Anticipation by prior fixed-dose or co-administered nasal formulations.
• Lack of written description for the broad concentration and excipient ranges.
• Lack of enablement for the full scope of the formulation claims.
• Non-infringement based on particle size, olopatadine crystallization, viscosity, pH, excipient concentration, or stability testing.

The narrowest formulation claim, claim 25, may be easier to design around but potentially easier to prove through product testing if a generic copies the excipient package. Claims 29, 39, and 47 are broader in ingredient architecture but may face greater validity scrutiny because they cover wider formulation permutations.

What generic launch risks exist?

A generic applicant could pursue several design-around strategies.

Separate-device strategy

A manufacturer could market mometasone and olopatadine in separate nasal devices. This may avoid the fixed-dose combination limitations but would not replicate the commercial convenience or therapeutic positioning of Ryaltris.

Alternative polymer strategy

Replacing sodium carboxymethyl cellulose with another suspending or viscosity-enhancing polymer could avoid claims 32 and 47-50. The product would still need to avoid the broader cellulose-derivative claim 29 if another cellulose derivative is used.

Concentration design-around

Moving olopatadine below 0.5% or above 0.8%, or mometasone outside 0.001% to 0.075%, could avoid the principal concentration limitations. Such changes may affect dose delivery and regulatory comparability.

Crystallization strategy

A product with a different olopatadine solid-state profile could avoid claim 39 or claim 46, but the manufacturer would need analytical evidence demonstrating the relevant level of crystalline olopatadine.

Physical-property design-around

A formulation outside the claimed pH, osmolality, particle-size, or viscosity ranges could avoid dependent claims. These properties are measurable and therefore likely to become central to any infringement dispute.

How strong is the patent estate?

The patent is strongest against a close copy of the commercial formulation. Its practical strength is lower against a materially different formulation.

Risk category	Assessment
Direct copy of Ryaltris-type composition	High
Product with the same active concentrations and CMC system	High
Product using different cellulose derivative	Moderate
Product using a non-cellulose suspending agent	Lower under claims 29 and 47
Separate mometasone and olopatadine products	Low under fixed-dose claims
Product with different olopatadine solid state	Moderate to lower
Method-of-use risk for seasonal rhinitis	High if product composition also matches
Method-of-use risk for perennial rhinitis	High if product composition also matches
Validity risk from broad functional language	Moderate
Manufacturing-process protection	Limited in the supplied claims

The patent does not claim a manufacturing process for milling mometasone, dissolving olopatadine, or preventing phase separation. Its manufacturing relevance arises indirectly because a manufacturer must control particle size, crystallinity, pH, viscosity, and composition during production.

What patent landscape surrounds mometasone and olopatadine?

The competitive landscape includes three product categories:

Product category	Representative product	Patent relevance
Mometasone monotherapy	Nasonex and generics	Separate corticosteroid patent and regulatory history
Olopatadine monotherapy	Patanase and generics	Separate antihistamine formulation and use patents
Fixed-dose combination nasal spray	Ryaltris	Directly relevant to Patent 9,750,754
Fluticasone-azelastine combination	Dymista and generics	Competing combination product with a different active pair

Dymista is the closest commercial comparator by product concept, but it does not use mometasone or olopatadine. Its patent estate does not automatically anticipate or invalidate the claimed Ryaltris formulation. The relevant comparison is technological rather than ingredient-specific: both products combine a nasal corticosteroid with an antihistamine in one spray.

Are there licensing deals or settlement agreements?

The supplied patent claims do not establish a licensing transaction, covenant not to sue, or Paragraph IV settlement. Public regulatory documents identify Glenmark as the sponsor and manufacturer associated with Ryaltris in the United States.[1][2]

No settlement terms should be inferred from the patent’s existence or from the commercial launch of Ryaltris. A settlement agreement would normally require review of federal litigation dockets, ANDA case filings, and any FTC or SEC disclosure.

What litigation affects Patent 9,750,754?

The principal litigation risk would arise after an ANDA applicant sends a Paragraph IV notice alleging that the patent is invalid, unenforceable, or not infringed. Potential litigation issues include:

1. Whether the ANDA product contains the claimed concentrations.
2. Whether mometasone is present as particles within the claimed size range.
3. Whether olopatadine is dissolved or partly crystalline.
4. Whether the product contains a hydrocolloid or cellulose derivative.
5. Whether phase separation is suppressed for the claimed period.
6. Whether the accused product is labeled for seasonal or perennial allergic rhinitis.
7. Whether the asserted patent claims are properly listed in the Orange Book.

Without a verified docket review, no specific Paragraph IV case, settlement date, or judgment should be attributed to Patent 9,750,754.

Key Takeaways

• U.S. Patent 9,750,754 is directed to fixed-dose aqueous intranasal combinations of mometasone and olopatadine.
• The patent covers both treatment methods and drug compositions.
• The most commercially relevant limitations are the 0.001%-0.075% mometasone range, 0.5%-0.8% olopatadine range, cellulose-based suspension system, pH of 3.3-4.1, and phase-separation or crystallization controls.
• Claim 25 is a narrow formulation claim closely aligned with the Ryaltris formulation.
• Claims 29, 39, and 47 create broader composition-based coverage that may reach alternative products.
• The patent’s expected base term falls in the 2033-2034 period, subject to official USPTO patent-term adjustment and any terminal disclaimer.
• A generic copying the commercial active concentrations and sodium carboxymethyl cellulose system faces the highest infringement exposure.
• Separate-device products, non-cellulose formulations, altered concentration ranges, and different crystallinity profiles offer potential design-around paths.
• The patent does not, based on the supplied claims, provide broad protection for mometasone, olopatadine, or all nasal corticosteroid-antihistamine combinations.

FAQs About U.S. Patent 9,750,754

Does Patent 9,750,754 cover all Ryaltris formulations?

No. It covers formulations and uses that satisfy the specific claimed concentrations, excipients, physical properties, and stability or crystallization limitations. A formulation can be commercially equivalent but fall outside one or more claim elements.

Can a generic avoid the patent by changing the preservative?

Possibly. Changing the preservative may avoid claim 25 if the substitute product no longer contains the recited excipient package. It would not necessarily avoid claims 29, 39, or 47.

Does the patent cover olopatadine crystals?

Claim 39 requires the composition to be substantially free of olopatadine hydrochloride crystals. Claim 46 narrows that requirement to less than 2% crystalline olopatadine hydrochloride.

Is a product outside the claimed pH range automatically non-infringing?

It may avoid claims that expressly require a pH of 3.3 to 4.1. It would not necessarily avoid claims without a pH limitation, and the full claim must be analyzed element by element.

Does the patent cover use in children?

The claims recite treatment of allergic rhinitis but do not specify an age group. Regulatory approval, labeling, and infringement analysis must be evaluated separately. The patent’s method claims are not limited to the patient age range unless another claim or prosecution-history limitation imposes one.

Sources

1. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,750,754, pharmaceutical composition comprising mometasone and olopatadine.
2. U.S. Food and Drug Administration. (2022). Ryaltris (mometasone furoate and olopatadine hydrochloride) nasal spray prescribing information.
3. U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation resources.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book.

Drugs Protected by US Patent 9,750,754

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			Y			TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE

Foreign Priority and PCT Information for Patent: 9,750,754

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 9,750,754

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
European Patent Office	3043773		132021000000191	Italy
European Patent Office	3043773		57/2021	Austria