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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 fifteen patents protecting this drug.

This drug has ninety patent family members in thirty-three 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 13, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RYALTRIS

International Patents:	90
US Patents:	15
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

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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 fifteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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
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

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

Country	Patent Number	Title	Estimated Expiration
China	105792828	使用莫米松和奥洛他定的组合治疗过敏性鼻炎 (Treatment of allergic rhinitis using a combination of mometasone and olopatadine)
Australia	2019224850	Treatment of allergic rhinitis in pediatric subjects using a combination of mometasone and olopatadine
Mexico	2020008741	TRATAMIENTO DE LA RINITIS ALERGICA EN SUJETOS PEDIATRICOS CON UNA COMBINACION DE MOMETASONA Y OLOPATADINA. (TREATMENT OF ALLERGIC RHINITIS IN PEDIATRIC SUBJECTS USING A COMBINATION OF MOMETASONE AND OLOPATADINE.)
South Korea	102709429

Supplementary Protection Certificates for RYALTRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
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	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

RYALTRIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RYALTRIS

Introduction to RYALTRIS

RYALTRIS, a nasal spray developed by Glenmark Pharmaceuticals, is a significant player in the treatment of seasonal and perennial allergic rhinitis. It is indicated for symptomatic treatment in adults and children over 12 years of age, relieving symptoms such as stuffy nose, runny nose, nasal itching, sneezing, and itchy, red, and watery eyes[1][3][4].

Global Commercialization

As of the latest reports, RYALTRIS has been commercialized in 31 geographies worldwide. The drug has also received approvals in 18 additional markets, where it is set to be launched over the next 3 to 6 months by either Glenmark or its partners[1][3][4].

Market Expansion Plans

Glenmark Pharmaceuticals is yet to launch RYALTRIS in major markets such as China and Brazil, which presents significant growth opportunities. The company has signed marketing applications for RYALTRIS in more than 70 markets globally, indicating a robust expansion strategy[1][3][4].

Projected Sales and Revenue

For the upcoming year, Glenmark anticipates RYALTRIS to generate approximately $80 million in sales, which is expected to boost the company's overall revenue. This projection underscores the product's potential to become a substantial contributor to Glenmark's financial performance[1][3][4].

Market Share and Peak Sales

Glenmark's Chairman and Managing Director, Glenn Saldanha, expressed optimism about RYALTRIS's market share, aiming for 15-20% of the market over the next five years. This ambitious target highlights the company's confidence in the product's market dominance and its potential for peak sales[1][3][4].

Financial Performance of Glenmark Pharmaceuticals

In the third quarter of 2023, Glenmark reported a consolidated revenue from operations of ₹2,910 crore, slightly lower than the corresponding quarter of the previous year. However, the company's shares saw a 1.67% increase, reflecting investor confidence in the company's future prospects, including the success of RYALTRIS[1][3][4].

Impact on Glenmark's Revenue

The commercial success of RYALTRIS is expected to significantly contribute to Glenmark's revenue growth. Given its current performance and future projections, RYALTRIS is poised to become one of the company's flagship products, driving both revenue and market share expansion[1][3][4].

Competitive Landscape

In the allergic rhinitis treatment market, RYALTRIS faces competition from existing products. However, its unique formulation and efficacy profile position it as a strong contender. Glenmark's strategic marketing and distribution efforts are crucial in capturing a substantial market share[1][3][4].

Regulatory Approvals and Launch Timeline

RYALTRIS has received regulatory approvals in multiple markets and is set for launch in several more over the coming months. This rapid approval and launch process is a testament to the drug's safety and efficacy, as well as Glenmark's efficient regulatory strategy[1][3][4].

Investor Confidence and Market Reaction

The positive market reaction to Glenmark's financial reports and the anticipated success of RYALTRIS reflect investor confidence in the company's growth trajectory. The successful commercialization of RYALTRIS is seen as a key factor in enhancing Glenmark's financial performance and market position[1][3][4].

Strategic Growth Initiatives

Glenmark is focusing on building global brands and enhancing its product mix. The in-licensing of specialty products like Winlevi® and Envafolimab, along with the successful commercialization of RYALTRIS, underscores the company's strategy to move up the value chain and improve operating margins[5].

Challenges and Opportunities

While Glenmark faces some headwinds, particularly in the US market, the company remains optimistic about regaining its growth trajectory. The successful commercialization of RYALTRIS and other strategic initiatives are expected to drive growth and improve financial performance despite macro-economic challenges[5].

Key Takeaways

• Global Reach: RYALTRIS has been commercialized in 31 markets and approved in 18 more, with plans for further expansion.
• Projected Sales: Anticipated sales of $80 million next year, contributing significantly to Glenmark's revenue.
• Market Share: Aiming for 15-20% market share over the next five years.
• Financial Impact: Expected to drive revenue growth and enhance Glenmark's financial performance.
• Regulatory Success: Rapid regulatory approvals and launches in multiple markets.
• Investor Confidence: Positive market reaction reflecting confidence in Glenmark's growth trajectory.

FAQs

Q: What is RYALTRIS used for?

A: RYALTRIS is used for the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age.

Q: How many markets has RYALTRIS been commercialized in?

A: RYALTRIS has been commercialized in 31 geographies worldwide.

Q: What are the projected sales for RYALTRIS next year?

A: Glenmark anticipates RYALTRIS to generate approximately $80 million in sales next year.

Q: Which major markets is RYALTRIS yet to be launched in?

A: RYALTRIS is yet to be launched in major markets such as China and Brazil.

Q: What is Glenmark's target market share for RYALTRIS over the next five years?

A: Glenmark aims for a market share of 15-20% for RYALTRIS over the next five years.

Cited Sources:

1. CNBC TV18 - Glenmark Pharmaceuticals eyes $80 million from Ryaltris sales next year[1].
2. Hikma - Combined 2022 Press Release and BFR[2].
3. Business Standard - Glenmark Pharma eyes $80 mn from it's nasal spray Ryaltris sales next year[3].
4. Indian Express - Glenmark Pharma eyes $80 million from Ryaltris sales next year[4].
5. Glenmark Pharmaceuticals - Investor Presentation: Q4 FY24[5].