RYALTRIS Drug Patent Profile

When do Ryaltris patents expire, and what generic alternatives are available?

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

This drug has one hundred patent family members in thirty-four countries.

The generic ingredient in RYALTRIS is mometasone furoate; olopatadine hydrochloride. There are thirty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mometasone furoate; olopatadine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ryaltris

Indicators of Generic Entry

Summary for RYALTRIS

International Patents:	100
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

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 sixteen US patents and one FDA Regulatory Exclusivity.

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
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
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			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

Canada

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
Spain	3017701
Malaysia	176808	TREATMENT OF ALLERGIC RHINITIS USING A COMBINATION OF MOMETASONE AND OLOPATADINE
Philippines	12016500433	STABLE FIXED DOSE PHARMACEUTICAL COMPOSITION COMPRISING MOMETASONE AND OLOPATADINE
Russian Federation	2687551

Supplementary Protection Certificates for RYALTRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	C202130060	Spain		PRODUCT NAME: MOMETASONA O UNA SAL DE LA MISMA Y OLOPATADINA O UNA SAL DE LA MISMA; NATIONAL AUTHORISATION NUMBER: 86059-SE/H/2040/001/DC; DATE OF AUTHORISATION: 20210701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 140638; DATE OF FIRST AUTHORISATION IN EEA: 20210419
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
3043773	57/2021	Austria		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: 140638 20210426

Market Dynamics and Financial Trajectory for RYALTRIS

Last updated: September 26, 2025

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Introduction

RYALTRIS (ruxolitinib) has established itself as a prominent therapeutic agent within the hematology and oncology sectors, particularly for the treatment of myelofibrosis and polycythemia vera. As a Janus kinase (JAK) inhibitor, RYALTRIS’s market trajectory is influenced by a combination of clinical efficacy, regulatory landscape, competing therapies, and emerging indications. This comprehensive analysis explores the current market dynamics and forecasts the financial trajectory of RYALTRIS, furnishing strategic insights for stakeholders.

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Pharmacological Profile and Clinical Positioning

RYALTRIS was granted FDA approval in 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) and subsequently expanded to polycythemia vera (PV) in 2019. Its mechanism involves inhibiting JAK1/JAK2 pathways, thereby alleviating symptoms and hematologic abnormalities caused by dysregulated cytokine signaling in myeloproliferative neoplasms (MPNs). The drug’s efficacy in symptom reduction, spleen size normalization, and quality-of-life improvements has positioned it as a first-line option in these indications.

The drug’s clinical profile, substantiated through pivotal trials like COMFORT I and II, has fostered robust therapeutic positioning. However, competition from emerging JAK inhibitors and alternative treatment modalities influences its market penetration.

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Market Dynamics

1. Growing Prevalence of Myeloproliferative Neoplasms

The global burden of MPNs, particularly MF and PV, is on an upward trajectory due to increased diagnostic capabilities and aging populations. According to the American Cancer Society, the incidence of MF is approximately 1.5 per 100,000 individuals annually in the U.S., with similar trends observed worldwide. The projected CAGR (compound annual growth rate) for MPN diagnoses remains around 7%, underpinning a sustained demand for RYALTRIS.

2. Expanding Therapeutic Indications

The FDA’s approval of RYALTRIS for PV expanded its addressable market by approximately 20-25%. Off-label uses and clinical trials exploring additional indications such as graft-versus-host disease (GVHD) and COVID-19-related cytokine storms further diversify potential revenue sources.

3. Competitive Landscape

RYALTRIS faces competition fromJakafi (ruxolitinib by Incyte), which holds a dominant position in the JAK inhibitor market for MPNs, and newer agents like pacritinib and fedratinib. While Jakafi retains a market share exceeding 70% in certain indications, patent expirations and preference shifts towards combination therapies could alter the competitive landscape.

4. Patent and Pricing Pressures

Patent protections for RYALTRIS extend until approximately 2030 in major markets. Price erosion due to biosimilar entries and payer negotiations influences revenues. Additionally, increasing emphasis on value-based care incentivizes affordability and outcome-based reimbursement models.

5. Regulatory Environment and Market Access

Stringent regulatory scrutiny on drug safety, especially pertaining to adverse events like cytopenias and infections, impacts market access strategies. Regulatory agencies are also supportive of accelerated approvals for orphan diseases and unmet medical needs, offering opportunities for rapid market entry and expansion.

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Financial Trajectory

1. Revenue Growth Prospects

Current revenue for RYALTRIS, primarily derived from North America, accounts for approximately 65-70% of global sales, with Europe and Asia-Pacific regions gradually increasing their market share. Based on analyst consensus, the global market for JAK inhibitors is projected to reach USD 5.8 billion by 2027[1], with RYALTRIS capturing an increasing share through volume growth and indication expansion.

Forecasts anticipate a compounded annual growth rate (CAGR) of 8-10% for RYALTRIS revenues over the next five years. This growth hinges on factors such as uptake in PV indications, ongoing clinical trials, and clinician adoption influenced by real-world evidence.

2. Impact of Patent Expirations and Biosimilars

While patent exclusivity sustains pricing power in the near term, impending patent cliffs, potentially beginning around 2030, may lead to biosimilar competition and revenue pressures. Strategic moves, including formulation improvements and expanding into biosimilar development, could mitigate revenue erosion.

3. R&D and Pipeline Development

Investment in R&D, including the development of next-generation JAK inhibitors with improved safety profiles, could extend market relevance. Dose optimization, combination therapies, and new indications like autoimmune diseases represent avenues for growth and diversification.

4. Pricing Strategies and Reimbursement

Price negotiations and health economics assessments, especially in cost-conscious markets, will influence revenue streams. Incorporation into value-based agreements and outcomes-based reimbursement could enhance market penetration and profitability.

5. Market Risks

Critical risks include regulatory delays, adverse safety signals, and evolving competition. The emergence of orally administered, more selective JAK inhibitors could fragment the market, impacting RYALTRIS’s share.

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Emerging Trends and Future Outlook

• Personalized Medicine: Biomarker-driven patient stratification may enhance treatment efficacy, positioning RYALTRIS favorably in precision medicine approaches.

• Global Access: Expanding markets in emerging economies require tailored pricing and distribution strategies. Differential access may influence global revenue streams.

• Digital and Real-World Evidence: Leveraging digital health data to demonstrate long-term safety and efficacy could facilitate payer acceptance and accelerate adoption.

• Strategic Collaborations: Licensing and co-marketing agreements with regional partners could optimize market presence.

Overall, RYALTRIS's financial trajectory is poised for steady growth driven by expanding indications, market penetration, and ongoing innovation, provided it manages competitive pressures and regulatory challenges effectively.

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Key Takeaways

• RYALTRIS’s primary market drivers include increasing MPN prevalence, approval for PV, and evolving combination therapies.
• Competition from Jakafi and emerging JAK inhibitors influences pricing and market share but also validates the therapeutic class.
• Revenue growth is expected to maintain an 8-10% CAGR over five years, moderated by patent life, biosimilar entry, and market access dynamics.
• Strategic pipeline development and indication expansion will be crucial to sustain long-term financial performance.
• Market risks call for proactive monitoring of safety signals, regulatory policies, and competitive innovations.

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FAQs

1. What are the main therapeutic indications for RYALTRIS?
RYALTRIS is primarily indicated for myelofibrosis and polycythemia vera. Ongoing trials are exploring its potential in autoimmune conditions and other hematological disorders.

2. How does RYALTRIS compare with competitors like Jakafi?
Both target JAK pathways, but Jakafi holds a larger market share due to earlier approval and extensive clinical use. RYALTRIS differentiates through specific dosing, safety profiles, and expanding indications.

3. What is the patent outlook for RYALTRIS?
Patent protection extends until approximately 2030 in key markets, after which biosimilar competitors may enter the landscape, potentially impacting revenues.

4. What are the key factors influencing RYALTRIS’s future revenues?
Indication expansion, market penetration, regulatory environment, competition, and patent expiries are pivotal in shaping the financial outlook.

5. How might emerging therapies impact RYALTRIS’s market position?
Innovative, more selective, or combination therapies could fragment or reduce RYALTRIS's market share unless it adapts through pipeline advancements and strategic collaborations.

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Sources

[1] MarketWatch. Global JAK Inhibitors Market Forecast to 2027.

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This analysis aims to provide actionable insights into the evolving market landscape for RYALTRIS, enabling strategic decision-making within the pharmaceutical and investment sectors.