KYNMOBI Drug Patent Profile

Which patents cover Kynmobi, and what generic alternatives are available?

Kynmobi is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are fourteen patents protecting this drug.

This drug has two hundred and fifty-four patent family members in twenty-six countries.

The generic ingredient in KYNMOBI is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kynmobi

A generic version of KYNMOBI was approved as apomorphine hydrochloride by TRUPHARMA on February 23^rd, 2022.

Summary for KYNMOBI

International Patents:	254
US Patents:	14
Applicants:	1
NDAs:	1
Clinical Trials:	1
Drug Prices:	Drug price information for KYNMOBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYNMOBI
What excipients (inactive ingredients) are in KYNMOBI?	KYNMOBI excipients list
DailyMed Link:	KYNMOBI at DailyMed

See drug prices for KYNMOBI

Recent Clinical Trials for KYNMOBI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
William Ondo, MD	Phase 4
Sunovion	Phase 4

See all KYNMOBI clinical trials

US Patents and Regulatory Information for KYNMOBI

KYNMOBI is protected by fourteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	8,603,514		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	9,669,019		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	10,420,763		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	10,449,146
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	9,669,021

Expired US Patents for KYNMOBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	8,603,514
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	9,855,221
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020	8,663,687
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	11,077,068
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	11,077,068

International Patents for KYNMOBI

When does loss-of-exclusivity occur for KYNMOBI?

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

Australia

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

South Africa

South Korea

Spain

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 KYNMOBI around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008100375
Japan	2012530066
Japan	2004537750
Australia	2018205083	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Japan	2005511522

KYNMOBI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KYNMOBI

Introduction to KYNMOBI

KYNMOBI, a sublingual film containing apomorphine hydrochloride, is a nonergoline dopamine agonist that has emerged as a significant treatment option for Parkinson's disease. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its potential impact and the challenges it may face.

Mechanism of Action and Clinical Significance

KYNMOBI works by stimulating dopamine receptors in the brain, helping to alleviate symptoms of Parkinson's disease such as tremors, rigidity, and bradykinesia. Its sublingual administration offers a rapid onset of action, making it particularly useful for managing acute motor fluctuations[4].

Market Assessment and Forecast

The market for KYNMOBI is anticipated to grow significantly over the next decade. Here are some key points from the market assessment:

• Geographical Reach: The drug is expected to make a substantial impact in the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Detailed forecasts from 2024 to 2032 indicate robust market penetration in these regions[1][4].

• Sales Projections: The forecasted sales data suggest that KYNMOBI will dynamically influence market trends, with strong market potential driven by its therapeutic efficacy and convenience of administration[1][4].

Regulatory Milestones and Developmental Activities

KYNMOBI has achieved several regulatory milestones that are crucial for its market success:

• Clinical Trials: The drug is currently in clinical development in Europe, with comprehensive information available on trial interventions, trial conditions, and trial status. These trials are pivotal in establishing the safety and efficacy of KYNMOBI[4].

• Regulatory Approvals: The report highlights key regulatory accomplishments and future projections, providing clarity on the strategic direction and expected outcomes of KYNMOBI's clinical assessments[1][4].

Market Dynamics and Competitive Landscape

The Parkinson's disease treatment market is evolving, and KYNMOBI is positioned to potentially shift current therapeutic paradigms:

• Emerging Therapies: The market is witnessing the development of novel treatment strategies and emerging therapies. These could influence KYNMOBI's dominance, but the drug's unique delivery mechanism and rapid onset of action are expected to maintain its competitive edge[1][4].

• Competitive Analysis: The report includes a comprehensive overview of market competitors and other emerging therapies in Parkinson's disease. This analysis helps stakeholders understand the competitive landscape and make informed decisions about their therapeutic portfolios[4].

Financial Performance and Projections

The financial trajectory of KYNMOBI is closely tied to its market performance and the overall financial health of its parent company, Aquestive Therapeutics:

• Revenue Growth: Aquestive Therapeutics reported total revenues of $50.6 million for the full year 2023, an increase from $47.7 million in 2022. This growth is partly attributed to the performance of KYNMOBI and other products[5].

• Net Loss Reduction: The company's net loss reduced significantly from $54.4 million in 2022 to $7.9 million in 2023. This reduction was driven by various factors, including other income from agreements and settlements, and lower research and development costs[5].

• Impairment Losses: However, it's important to note that companies involved in the development of KYNMOBI, such as Sumitomo Pharma, have faced significant impairment losses on intangible assets related to the drug. For instance, Sumitomo Pharma booked an impairment loss of 55.4 billion yen on the entire value of the patents for KYNMOBI[2].

SWOT Analysis and Market Strategies

A comprehensive SWOT analysis is crucial for understanding the strengths, weaknesses, opportunities, and threats associated with KYNMOBI:

• Strengths: KYNMOBI's rapid onset of action, sublingual delivery, and strong clinical development status are significant strengths. These factors position the drug favorably in the market[1][4].

• Weaknesses: The drug faces challenges from emerging therapies and potential regulatory hurdles. Additionally, the financial performance of the parent company can impact the drug's market trajectory[1][4].

• Opportunities: The growing demand for effective Parkinson's disease treatments and the expanding healthcare spending globally present significant opportunities for KYNMOBI. Strategic partnerships and licensing agreements can further enhance its market presence[1][4].

• Threats: The competitive landscape, including other emerging therapies, and economic factors such as changes in forex rates and impairment losses, pose threats to KYNMOBI's market dominance[1][2][4].

Key Takeaways

• Market Growth: KYNMOBI is expected to significantly influence the Parkinson's disease treatment market with robust sales projections until 2032.
• Clinical Significance: The drug's sublingual administration and rapid onset of action make it a valuable treatment option.
• Regulatory Milestones: Achieving key regulatory approvals is crucial for the drug's market success.
• Financial Performance: The financial health of the parent company and the drug's revenue growth are closely linked.
• Competitive Landscape: Emerging therapies and market dynamics will continue to shape KYNMOBI's market position.

FAQs

What is KYNMOBI and how does it work?

KYNMOBI is a sublingual film containing apomorphine hydrochloride, a nonergoline dopamine agonist. It works by stimulating dopamine receptors in the brain to alleviate symptoms of Parkinson's disease.

Which markets is KYNMOBI expected to impact significantly?

KYNMOBI is expected to make a substantial impact in the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

What are the key regulatory milestones for KYNMOBI?

KYNMOBI has achieved several regulatory milestones, including clinical trials in Europe and key approvals that are pivotal for its market success.

How does KYNMOBI compare to other Parkinson's disease treatments?

KYNMOBI's unique sublingual delivery and rapid onset of action differentiate it from other treatments, but it faces competition from emerging therapies.

What are the financial implications for companies involved in KYNMOBI's development?

Companies like Aquestive Therapeutics and Sumitomo Pharma have seen mixed financial results, with revenue growth but also significant impairment losses on intangible assets related to KYNMOBI.

Sources

1. ResearchAndMarkets.com, "Landscape of KYNMOBI in Parkinson's Disease Market Through 2032 - Robust Clinical Development and Anticipated Performance."
2. Sumitomo Pharma, "Consolidated Financial Results for the Year Ended March 31, 2023."
3. Aquestive Therapeutics, Inc., "Aquestive Therapeutics, Inc. - Investor Relations."
4. GlobeNewswire, "KYNMOBI Drug Landscape Research 2024: A Sublingual Film Containing Apomorphine Hydrochloride - Market Size, Forecast, and Market Insight for 7MM - 2019-2032."
5. Aquestive Therapeutics, "Aquestive Therapeutics Reports Full Year 2023 Financial Results."