US Patent 10,016,443: Scope, Claim Construction, Expiration, and Ryaltris Patent Landscape

US Patent No. 10,016,443 protects a specific treatment regimen for allergic rhinitis using the fixed-dose nasal combination of mometasone furoate and olopatadine hydrochloride. The patent does not broadly claim either active ingredient, the nasal spray device, or every formulation containing the two drugs. Its principal protection is a method-of-use regimen requiring a defined dose, dosing frequency, patient population or disease condition, and relief or onset within 15 minutes.

The patent is closely associated with Glenmark’s Ryaltris nasal spray. Each spray contains approximately 25 mcg of mometasone furoate and 665 mcg of olopatadine hydrochloride. The claimed regimen is two sprays per nostril twice daily, equivalent to four sprays per administration and eight sprays per day. The patent term is expected to extend into January 2034, subject to any patent-term adjustment or other record-specific modification. (U.S. Patent No. 10,016,443, 2018; U.S. Food and Drug Administration [FDA], 2021)

What does US Patent 10,016,443 protect?

The patent protects methods of treating allergic rhinitis with the fixed-dose mometasone-olopatadine nasal composition at a specified dosing schedule and with rapid symptom relief.

Claim element	Requirement
Active ingredients	Mometasone furoate and olopatadine hydrochloride
Dosage per spray	About 25 mcg mometasone furoate and about 665 mcg olopatadine hydrochloride
Administration	Nasal administration
Dose	Two sprays per nostril
Frequency	Twice daily
Indication	Allergic rhinitis
Onset or relief	Within 15 minutes of administration
Patient limitation	Human subject; several dependent claims require age 12 or older
Disease subtypes	Seasonal, perennial, or persistent allergic rhinitis
Symptoms	Nasal symptoms, including congestion, rhinorrhea, itching, and sneezing; some claims also cover non-nasal symptoms

The core inventive combination is not simply the co-administration of two known drugs. The claims require a fixed-dose product and a specific rapid-onset treatment protocol.

What is not directly claimed?

The patent claims treatment methods rather than a composition per se. It does not, based on the supplied claims, independently claim:

Mometasone furoate as a chemical compound.
Olopatadine hydrochloride as a chemical compound.
A generic composition containing both ingredients at any concentration.
A metered-dose nasal spray device without the claimed regimen.
Once-daily administration.
One spray per nostril.
A dose containing different amounts of either active ingredient.
Treatment of a disease other than allergic rhinitis.
Administration that does not provide the claimed 15-minute relief or onset.

A competing product could therefore avoid literal infringement by changing a required claim element, although the commercial and regulatory consequences of that change would need separate analysis.

How should the independent claims be construed?

Claims 1 and 9 are the principal independent claims.

Claim 1

Claim 1 requires all of the following:

A human subject in need of treatment.
One or more symptoms associated with allergic rhinitis.
Nasal administration.
Twice-daily dosing.
Two sprays per nostril.
A fixed-dose composition.
Approximately 25 mcg of mometasone furoate per spray.
Approximately 665 mcg of olopatadine hydrochloride per spray.
Relief from one or more allergic-rhinitis symptoms within 15 minutes.

The 15-minute limitation is important. A product with the same dose and schedule may not satisfy claim 1 if the relevant treatment effect does not occur within the claimed period. The limitation also creates proof questions involving clinical-study design, baseline symptom scoring, statistical significance, and the meaning of “relief.”

Claim 9

Claim 9 is also independent and is framed as a method of administering a pharmaceutical composition for twice-daily nasal use. It requires:

Two sprays per nostril.
About 25 mcg of mometasone furoate per spray.
About 665 mcg of olopatadine hydrochloride per spray.
An onset of action within 15 minutes for allergic-rhinitis treatment.

Claim 9 may be broader in wording because it focuses on the composition’s intended administration and onset of action rather than expressly requiring the subject to experience relief from a symptom. In practice, however, it retains the same central dose, schedule, indication, and rapid-onset limitations.

How do claims 2 through 24 expand the patent scope?

The dependent claims divide the core regimen into symptom, age, disease, and timing categories.

Claims	Added limitation
2	Nasal or non-nasal symptoms
3	Nasal symptoms
4	Congestion, rhinorrhea, itching, or sneezing
5	Subject is at least 12 years old
6	Seasonal, perennial, or persistent allergic rhinitis
7	Seasonal allergic rhinitis
8	Perennial allergic rhinitis
10	At least 12 years old, dependent on claim 1
11	Seasonal allergic rhinitis
12	Perennial allergic rhinitis
13-14	Seasonal allergic rhinitis in a subject at least 12 years old
15-16	Seasonal allergic rhinitis with specified nasal symptoms
17-18	Claim 9 narrowed to specified nasal symptoms
19-20	Seasonal allergic rhinitis with specified nasal symptoms
21	Relief from nasal symptoms within 15 minutes
22	Relief from seasonal-allergic-rhinitis nasal symptoms within 15 minutes
23	Claim 9 narrowed to relief from nasal symptoms within 15 minutes
24	Seasonal-allergic-rhinitis nasal-symptom relief within 15 minutes

Claims 10 through 12 largely repeat limitations already present in earlier dependent-claim branches. That redundancy does not necessarily eliminate their legal effect. Each claim must still be assessed as a separate statutory claim, and an invalidity challenge to one dependent claim does not automatically dispose of every other claim.

What formulation and dosage are protected?

The protected dosage is unusually specific:

25 mcg mometasone furoate per spray.
665 mcg olopatadine hydrochloride per spray.
Two sprays in each nostril.
Twice daily.

At the full regimen, the daily nominal exposure is:

Ingredient	Per spray	Per administration	Daily total
Mometasone furoate	25 mcg	100 mcg	200 mcg
Olopatadine hydrochloride	665 mcg	2,660 mcg	5,320 mcg

The formulation is commercially associated with Ryaltris, approved for treatment of seasonal allergic rhinitis in patients aged 12 years and older. The FDA-approved labeling identifies the same dose of two sprays in each nostril twice daily. (FDA, 2021)

The claims use “about,” which introduces a range question. Courts generally interpret “about” in light of the specification, prosecution history, measurement precision, formulation variability, and the technical meaning used by a person skilled in the field. A modest manufacturing variance may remain within the claim, while a materially different strength may not.

The patent does not appear, from the supplied claims, to require a particular preservative, excipient, viscosity, particle-size distribution, spray pattern, container, pump, or manufacturing process. Those features may be protected by separate formulation or device patents, but they are not limitations of the claims reproduced by the user.

When does US Patent 10,016,443 expire?

The patent was issued on July 10, 2018. Its expected expiration is in January 2034 based on the patent family’s priority and filing chronology. The exact terminal date should be taken from the USPTO patent record and any applicable patent-term-adjustment calculation. (U.S. Patent and Trademark Office [USPTO], n.d.-a)

Event	Date or period
Patent issued	July 10, 2018
Expected expiration	January 2034
Product associated with patent	Ryaltris nasal spray
FDA approval of Ryaltris	2021
Relevant exclusivity type	Small-molecule drug patent and NDA exclusivity, not biologic exclusivity

The patent’s remaining commercial value depends on whether later patents, regulatory exclusivity, litigation outcomes, settlements, or additional Orange Book listings create a later effective generic-entry date.

What is the Orange Book status of US Patent 10,016,443?

US Patent 10,016,443 is associated with the Ryaltris reference product and is relevant to an abbreviated new drug application challenge. Because the patent claims a method of treatment rather than the active ingredients themselves, its Orange Book relevance is principally method-of-use protection.

A generic applicant can address a listed method-of-use patent through:

Paragraph IV certification, asserting that the patent is invalid, unenforceable, or not infringed.
A section viii statement, where the generic label omits the patented use and the remaining labeling supports a lawful noninfringing use.
A Paragraph III certification, accepting delayed approval until patent expiration.

The practical availability of a section viii carve-out depends on the scope of the approved indication and whether the unpatented use can be marketed without encouraging use of the patented regimen. If the approved product’s principal or only commercial use corresponds to the patented indication, a carve-out may provide limited protection against induced-infringement allegations.

What Paragraph IV challenges and litigation risks exist?

A Paragraph IV filing would likely target one or more of four issues.

Anticipation

A challenger would search for a single prior-art reference disclosing the complete combination of:

The fixed-dose mometasone-olopatadine product.
The claimed strengths.
Two sprays per nostril twice daily.
Allergic-rhinitis treatment.
Relief or onset within 15 minutes.

Prior art separately disclosing mometasone nasal spray and olopatadine nasal spray would not, by itself, anticipate every claim. It could still contribute to an obviousness challenge.

Obviousness

Obviousness is likely the principal validity risk. Both active ingredients were known antihistamine and corticosteroid treatments for allergic rhinitis. A challenger could argue that combining them in a nasal spray at known or predictable strengths would have been an obvious formulation and treatment choice.

The patent owner would likely rely on the rapid-onset result, fixed-dose performance, clinical data, and any unexpected improvement over the individual products or prior combinations. The strength of that defense depends on the patent specification and prosecution record, not merely on the existence of a 15-minute limitation.

Written description and enablement

The claims cover multiple symptom categories and disease subtypes. A challenger could argue that the specification does not adequately support the full breadth of relief claims across:

Nasal and non-nasal symptoms.
Seasonal, perennial, and persistent allergic rhinitis.
All human subjects covered by the claims.
A 15-minute onset or relief period.

That argument would be stronger if the supporting clinical evidence was limited to seasonal allergic rhinitis, patients aged 12 years or older, or particular endpoints.

Indefiniteness

Potential claim-construction disputes include:

The meaning of “about.”
Whether “relief within 15 minutes” requires clinically meaningful relief, statistically significant relief, or any measurable improvement.
Whether “onset of action” is distinct from symptom relief.
Whether the result must occur after every administration or is established by clinical-study averages.

The prosecution history and specification would control the analysis.

Which companies are most exposed to the patent?

Glenmark is the principal commercial stakeholder associated with Ryaltris. A generic manufacturer seeking to market the same fixed-dose product would face the greatest risk if its ANDA label includes:

The same two-sprays-per-nostril twice-daily regimen.
The same patient population.
Seasonal or perennial allergic-rhinitis treatment.
Statements describing relief or onset within 15 minutes.

Potentially exposed parties include:

ANDA applicants for a generic mometasone furoate/olopatadine hydrochloride nasal spray.
Contract manufacturers producing an equivalent product for an ANDA sponsor.
Distributors or commercial partners whose labeling or promotional materials encourage the patented method.
Healthcare providers and pharmacies only in more fact-specific induced-infringement scenarios.

A generic product with a different strength, a different dosing frequency, or a label that omits the patented use may reduce literal infringement risk. It may also lose therapeutic equivalence, market acceptance, or FDA labeling advantages.

Does the patent create biosimilar risk?

No. Ryaltris is a small-molecule combination nasal spray, not a biologic. The relevant competitive pathway is an ANDA for a generic drug, not a biosimilar application under the Public Health Service Act.

The key regulatory and patent mechanisms are therefore:

FDA approval under section 505(j).
Orange Book patent certification.
Paragraph IV litigation under the Hatch-Waxman framework.
Potential 30-month stays following timely patent litigation.
Label carve-outs under section viii.

How does the patent compare with patents for competing allergy products?

Product or category	Active ingredients	Primary patent issue	Relationship to US 10,016,443
Ryaltris	Mometasone furoate plus olopatadine hydrochloride	Fixed-dose regimen and rapid onset	Directly associated
Nasonex	Mometasone furoate	Historical ingredient, formulation, and use patents	Prior-art and competitive background
Patanase	Olopatadine hydrochloride	Historical ingredient and nasal-use patents	Prior-art and competitive background
Dymista	Fluticasone propionate plus azelastine hydrochloride	Different fixed-dose combination	Not a literal product match
Generic single-agent sprays	Mometasone or olopatadine	Separate active-ingredient products	May compete clinically without practicing the combination claims

The patent’s differentiation is the combination of a corticosteroid and antihistamine in a single fixed-dose spray together with the claimed rapid-onset regimen. It is narrower than a composition patent covering all formulations but potentially more difficult to avoid while preserving the Ryaltris dose and labeling.

Are there manufacturing or intellectual-property barriers beyond this patent?

The supplied claims do not cover manufacturing methods. Commercial entry could still face separate barriers involving:

Suspension uniformity.
Dose-metering accuracy.
Spray-content uniformity.
Device compatibility.
Microbiological control.
Stability of the two active ingredients.
Particle-size and deposition characteristics.
Bioequivalence and comparative clinical performance.

A generic applicant must demonstrate pharmaceutical equivalence and bioequivalence under FDA requirements. A formulation or device patent could create additional risk even if US 10,016,443 is invalidated or avoided. The complete Orange Book patent set and related family members must therefore be reviewed separately from this method patent.

Are there licensing deals or settlement agreements tied to the patent?

No specific public licensing transaction or Paragraph IV settlement should be attributed to US 10,016,443 without a corresponding agreement, court docket, SEC filing, or FDA record. The public commercial association is with Glenmark’s Ryaltris product and its US commercialization operations.

A settlement could alter the effective generic-entry date through an agreed launch date, license, or covenant not to sue. That date should not be inferred from the patent’s nominal expiration alone.

What is the likely generic launch scenario?

The highest-risk scenario for the patent owner is an ANDA applicant that copies the Ryaltris strength, dose, indication, and rapid-onset labeling. That applicant would likely file a Paragraph IV certification if it intends to launch before patent expiration.

The main launch scenarios are:

Full-label generic: Highest infringement exposure, particularly if the label states rapid relief within 15 minutes.
Section viii carve-out: Lower method-of-use exposure, but commercial viability depends on whether a meaningful unpatented use remains.
Alternative-strength product: May avoid the literal dose limitations but would require separate FDA development and may not be therapeutically substitutable.
Post-expiration launch: Lowest patent risk, assuming no later-listed patent creates a separate barrier.
Settlement-based launch: Entry date depends on the negotiated agreement and any court or regulatory restrictions.

Key Takeaways

US Patent 10,016,443 is a method-of-treatment patent associated with Ryaltris.
Its core limitations are the fixed-dose combination, two sprays per nostril twice daily, and relief or onset within 15 minutes.
The patent does not broadly claim mometasone furoate, olopatadine hydrochloride, or every combination product containing them.
The expected patent expiration is in January 2034, subject to the official USPTO term calculation.
A generic applicant would likely face a Paragraph IV strategy if it copies the Ryaltris regimen and label.
Obviousness, enablement, written description, “about” dosage construction, and the meaning of 15-minute relief are the principal validity and infringement issues.
No biosimilar pathway applies because Ryaltris is a small-molecule nasal spray.
Separate formulation, device, or manufacturing patents may create additional barriers beyond US 10,016,443.
No specific licensing or settlement arrangement should be assumed without a public transaction or court record.

FAQs About US Patent 10,016,443

What drug is covered by US Patent 10,016,443?

The patent covers treatment using a fixed-dose nasal spray containing mometasone furoate and olopatadine hydrochloride at approximately 25 mcg and 665 mcg per spray, respectively. It is associated with Ryaltris.

Can a generic use the same ingredients but a different dose?

A different dose may avoid literal infringement of the dosage limitations, but the product would require separate FDA development and could face other patents or regulatory barriers.

Does the patent cover once-daily administration?

The supplied claims require twice-daily administration. Once-daily use is not expressly covered by those claims.

Does a generic need to challenge this patent to obtain FDA approval?

Not necessarily. An applicant may certify to expiration, file a Paragraph IV challenge, or pursue a section viii labeling carve-out if the regulatory and commercial facts support that approach.

Is US Patent 10,016,443 a composition patent?

No. The supplied claims are method-of-treatment claims. They protect use of the composition under a defined regimen rather than the composition in the abstract.

References

Glenmark Pharmaceuticals Ltd. (2018). U.S. Patent No. 10,016,443, treatment of allergic rhinitis. U.S. Patent and Trademark Office.
U.S. Food and Drug Administration. (2021). Ryaltris (mometasone furoate and olopatadine hydrochloride) nasal spray prescribing information. https://www.accessdata.fda.gov
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Patent and Trademark Office. (n.d.-a). Patent Center: U.S. Patent No. 10,016,443. https://patentcenter.uspto.gov
U.S. Patent and Trademark Office. (n.d.-b). Patent term adjustment and patent term extension information. https://www.uspto.gov/patents/laws/patent-term-adjustment-patent-term-extension-performance-report-performance-reports

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	10,016,443	⤷ Start Trial				TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE	⤷ 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

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	3174/MUM/2013	Oct 4, 2013

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

Details for Patent: 10,016,443

Which drugs does patent 10,016,443 protect, and when does it expire?

Summary for Patent: 10,016,443