RYALTRIS Drug Patent Profile

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When do Ryaltris patents expire, and when can generic versions of Ryaltris launch?

Ryaltris is a drug marketed by Glenmark Speclt and is included in one NDA. There are seventeen patents protecting this drug.

The generic ingredient in RYALTRIS is mometasone furoate; olopatadine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the mometasone furoate; olopatadine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ryaltris

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 8, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RYALTRIS

US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for RYALTRIS
What excipients (inactive ingredients) are in RYALTRIS?	RYALTRIS excipients list
DailyMed Link:	RYALTRIS at DailyMed

See drug prices for RYALTRIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RYALTRIS

Constraining patent/regulatory exclusivity:

12,303,635

NDA:

211746

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for RYALTRIS

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

US Patents and Regulatory Information for RYALTRIS

RYALTRIS is protected by seventeen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 12,303,635.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,765,686
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,016,443
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,548,907
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	11,679,210		Y

International Patents for RYALTRIS

When does loss-of-exclusivity occur for RYALTRIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RYALTRIS around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018260934	Dispensing device and pharmaceutical compositions for the treatment of rhinitis
Australia	2019224850	Treatment of allergic rhinitis in pediatric subjects using a combination of mometasone and olopatadine
Brazil	112015018252	composição farmacêutica aquosa de dose fixa estável para administração nasal para um ser humano, composição de suspensão aquosa farmacêutica de dose fixa estável para administração nasal para um ser humano, suspensão estável adequada para administração nasal a um ser humano, método para tratar rinite em um ser humano necessitando do mesmo, uso da composição farmacêutica para administração nasal, método para liberar uma composição farmacêutica e kit
Brazil	112018076537	dispositivo de distribuição e composição farmacêutica para administração nasal a um humano
Brazil	112020016817	método para tratar sintomas associados à rinite alérgica, método para fornecer um início de ação mais rápido para alívio da rinite alérgica e método para tratar um sujeito humano pediátrico que sofre de rinite alérgica

Supplementary Protection Certificates for RYALTRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	CA 2021 00050	Denmark		PRODUCT NAME: MOMETASON ELLER ET SALT DERAF OG OLOPATADIN ELLER ET SALT DERAF; NAT. REG. NO/DATE: 63820 20210706; FIRST REG. NO/DATE: AT 140638 20210426
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
3043773	122021000085	Germany		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: 2205824.00.00 20211117; FIRST REGISTRATION: OESTERREICH 140638 20210426

RYALTRIS (fluticasone propionate + olopatadine) market dynamics and financial trajectory: revenue drivers, payer access, competition, and loss-of-exclusivity exposure

Last updated: July 20, 2026

What is RYALTRIS and how is it priced in the market?

RYALTRIS is a fixed-dose combination intranasal product containing fluticasone propionate (corticosteroid) and olopatadine (antihistamine). It is marketed for the treatment of seasonal allergic rhinitis (SAR).

Commercial “who pays” structure

• Primary payer mix: PBM-managed commercial and Medicare Part D, with repeat demand driven by seasonal peaks and plan-specific formulary decisions.
• Likely utilization pattern: concentrated demand in spring and early summer for SAR; lower off-season pull-through unless plans maintain incentives year-round.

Pricing and access

• Intranasal allergy products generally compete on tier placement (preferred vs nonpreferred), copay, and step therapy rather than large list-price moves year over year.
• Combination products with both an antihistamine and a steroid typically seek formulary placement that avoids loss to single-agent competitors.

Key implication for financial trajectory

• Net sales typically track a blend of: (1) seasonal volume, (2) formulary breadth, (3) patient adherence to twice-daily intranasal dosing, and (4) rebates tied to formulary status.

How do market dynamics for allergic rhinitis shape RYALTRIS sales?

Demand sensitivity

• Allergic rhinitis is seasonal, with demand elasticity tied to pollen burden, switching behavior after label awareness, and the competitive set at the point of care (primary care and ENT).

Competitive switching patterns Patients and prescribers switch based on:

• Efficacy perception for dual-action symptom control (sneezing, rhinorrhea, itching, congestion).
• Safety and tolerability (intranasal steroid class effects; olopatadine tolerability profile).
• Administration convenience (combination vs separate prescriptions).
• Formulary position and insurance-driven substitution.

Distribution and channel

• Most volume is pulled through retail pharmacy under PBM contracts. Specialty channel is not relevant as the product is not typically treated as a specialty drug.

Financial outcome

• RYALTRIS net sales trend is usually less about market creation and more about capturing incremental share from (a) intranasal steroids alone, (b) antihistamine sprays, and (c) fixed combinations where present.

Which competitors pressure RYALTRIS and how does the competitive set affect net sales?

RYALTRIS competes in intranasal allergy with:

• Intranasal corticosteroids (e.g., fluticasone, mometasone, budesonide and branded alternatives)
• Intranasal antihistamines (e.g., azelastine products and olopatadine-containing products where applicable)
• Combination intranasal regimens where payers and prescribers can mix and match

What matters for share

• If payers place RYALTRIS on nonpreferred tiers, it loses to generics of intranasal steroids and to PBM-preferred branded sprays.
• If RYALTRIS maintains preferred access, it can consolidate patient treatment by reducing regimen complexity.

Featured snippet style answer

• RYALTRIS is exposed to share pressure from low-cost intranasal steroid generics and payer-preferred intranasal antihistamine products. Its ability to hold formulary placement is the main determinant of sustained net sales.

When does RYALTRIS lose exclusivity and what are the generic entry risks?

RYALTRIS is built around a combination using existing active ingredients (fluticasone and olopatadine). The market threat is typically anchored in:

• Formulation and combination patents (device, delivery, particle/formulation characteristics, stability, and method-of-use)
• Orange Book patent listings for the specific approved NDA (or relevant supplement) and their expiration timing
• Paragraph IV incentives (if ANDA challengers believe listed patents are invalid or not infringed)

Generic entry risk profile

• Combination products face higher IP barriers than single-agent generics because ANDA filers must navigate claims on:
  • specific combination formulation
  • specific device and dosing regimen
  • method-of-use claims for allergy indications
• Risk increases as listed patents approach expiration and as settlement windows open.

Key financial driver

• Financial trajectory often steepens upward pre-expiration (assuming steady formulary uptake) and can flatten or reverse ahead of entry if payers anticipate switch.

What is the Orange Book status of RYALTRIS and which patent expirations control exclusivity?

Orange Book status is the practical map of:

• Competing “hard” IP (expiration of listed patents)
• Exclusivity regimes (regulatory exclusivity like 5-year/3-year exclusivity, plus pediatric exclusivity where applicable)
• Timing for Paragraph IV strategy (challengers target the earliest date an ANDA can launch, typically after patent expiration or with design-around if allowed)

Featured snippet style answer

• The controlling dates for generic launch are the earliest expiration of Orange Book-listed patents tied to RYALTRIS’s NDA approvals plus any exclusivity not bound to patent expiration. Those dates shape the window for generic ANDA approvals and possible launch dates.

How strong is the patent estate for RYALTRIS (combination, formulation, and method-of-use coverage)?

For combination intranasal products, patent estates often break down into three layers:

1) Combination formulation and composition claims

Typical coverage includes:

• ratio of fluticasone to olopatadine
• specific formulation excipients and stability profiles
• delivery properties that support consistent dosing and shelf-life

2) Method-of-treatment and method-of-use claims

Coverage typically includes:

• treatment regimens and endpoints for SAR
• use in patients with specific symptom profiles or time-to-onset targets

3) Manufacturing and device/dosing apparatus claims

Coverage can include:

• manufacturing steps that control spray characteristics
• device-related claims for metered dose delivery, mist droplet size distribution, or dosing uniformity

Financial relevance

• If formulation and method-of-use claims remain enforceable near expiration, ANDA launch is delayed, which preserves pricing power and revenue stability.

What patent litigation or ANDA challenges affect RYALTRIS market access?

Generic and branded revenue trajectories are affected by:

• injunction outcomes and settlement agreements
• delayed effective launch dates after litigation settlements
• carve-outs for specific dosage forms, strengths, or indications

Commercial impact pathways

• Litigation can keep RYALTRIS on formularies by reducing near-term competitive substitution.
• Settlements can create branded “no-touch” periods or shift launch timing by years.

Featured snippet style answer

• RYALTRIS financial exposure depends on whether ANDA litigation forces redesign, triggers delayed launch, or ends in a pay-for-delay style settlement that extends branded revenue.

How does RYALTRIS compare with other intranasal allergy products by market outcomes?

Revenue comparability Intranasal allergy products show similar dynamics:

• branded products benefit from combination differentiation and early formulary uptake
• later, performance depends on whether generics or therapeutically equivalent branded products secure preferred status

Key comparables that drive switching

• Any intranasal steroid product that is PBM-preferred and priced with favorable copays
• Any intranasal antihistamine product with strong outcomes at the same payer tier as RYALTRIS

Net sales sensitivity

• Combination products can outperform single agents when payers reward co-formulated therapy, but they underperform if payers force single-agent substitution.

How many patents cover RYALTRIS in major jurisdictions, and where is the estate most vulnerable?

The “most vulnerable” points are usually:

• jurisdictions where formulation/device patents are narrower or not filed
• areas where enforcement history is limited
• timing where one or two core patents expire first and open an avenue for generic design-around

Financial impact

• If the earliest expiration is soon, branded pricing power erodes as payers preemptively switch or reduce rebates.

What are the main formulation and delivery barriers preventing generic substitution?

Generic substitution for intranasal combinations is constrained by:

• ability to match particle size distribution and spray characteristics
• bioequivalence for nasal delivery performance
• stability of the combination formulation in a packaged device
• ability to replicate dosing uniformity and patient usability

Commercial impact

• When delivery matching is difficult, ANDA approval delays or litigation increases, protecting branded net sales longer than expiration alone suggests.

What commercial outcomes should be expected from RYALTRIS given typical seasonal allergic rhinitis patterns?

A standard seasonal rhythm for allergic rhinitis informs financial trajectory:

• Peak seasonality: Q1-Q2 often carry the largest demand for SAR in the US, with Q3 depending on geography and weather.
• Adherence and switching: repeated treatment supports staying power if formulary placement is stable.
• Payer behavior: PBM contracting and seasonal formulary updates can cause step changes in net sales across years.

Expected trajectory shape

• If formulary coverage expands: sales scale through the next seasonal cycle.
• If tier placement weakens: share loss shows up within 1 season and can compound.

Key takeaways on RYALTRIS financial trajectory

• RYALTRIS net sales dynamics are primarily governed by formulary access and rebate intensity, not just product differentiation.
• The largest generic-entry risk is the earliest expiration of Orange Book-listed patents tied to the RYALTRIS NDA and any controlling exclusivity; that determines ANDA timing and potential launch.
• Intranasal combination products typically face stronger barriers than single-agent generics, so the most important financial inflection points are usually tied to combination formulation and method-of-use patent expirations rather than merely regulatory approval dates.
• Any litigation or settlement that affects launch timing can materially alter the slope of the revenue curve approaching loss of exclusivity.

FAQs

1) What makes generic entry harder for intranasal combination allergy products like RYALTRIS?
Combination formulation constraints, nasal delivery performance requirements, and method-of-use and formulation patent coverage tend to slow or deter ANDA launches.

2) How do PBM formulary changes typically affect intranasal allergy branded net sales mid-year?
Step-tier placement changes and rebate renegotiations can shift patient volume within one seasonal cycle, producing noticeable quarterly swings.

3) What is the main driver of RYALTRIS seasonal revenue variability?
Season length and pollen intensity interact with formulary status and patient adherence to twice-daily dosing.

4) Do method-of-use patents matter more than composition patents for ANDA challenges in allergic rhinitis?
Method-of-use and treatment regimen claims can materially affect whether an ANDA can launch for the same labeled indication without design-around.

5) How should investors model RYALTRIS revenue into the loss-of-exclusivity window?
Model around the earliest Orange Book-controlled date for launch eligibility, plus the typical delay from litigation, settlements, and payer pre-switch behavior.

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References

No sources were cited in this response.

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