Apomorphine hydrochloride - Generic Drug Details

What are the generic drug sources for apomorphine hydrochloride and what is the scope of freedom to operate?

Apomorphine hydrochloride is the generic ingredient in three branded drugs marketed by Sumitomo Pharma Am, Mdd Us, and Trupharma, and is included in three NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apomorphine hydrochloride has two hundred and fifty-four patent family members in twenty-six countries.

There are three drug master file entries for apomorphine hydrochloride. Two suppliers are listed for this compound.

Summary for apomorphine hydrochloride

International Patents:	254
US Patents:	14
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	48
Patent Applications:	6,214
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apomorphine hydrochloride
What excipients (inactive ingredients) are in apomorphine hydrochloride?	apomorphine hydrochloride excipients list
DailyMed Link:	apomorphine hydrochloride at DailyMed

Recent Clinical Trials for apomorphine hydrochloride

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

Sponsor	Phase
Alexza Pharmaceuticals, Inc.	Phase 2
DSG	Phase 2
Peachtree BioResearch Solutions	Phase 2

See all apomorphine hydrochloride clinical trials

Pharmacology for apomorphine hydrochloride

Drug Class	Dopaminergic Agonist
Mechanism of Action	Dopamine Agonists

Medical Subject Heading (MeSH) Categories for apomorphine hydrochloride

Dopamine Agonists

Emetics

Anatomical Therapeutic Chemical (ATC) Classes for apomorphine hydrochloride

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for apomorphine hydrochloride

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	210875-002	May 21, 2020		DISCN	Yes	No			Y
Mdd Us	APOKYN	apomorphine hydrochloride	INJECTABLE;SUBCUTANEOUS	021264-001	Apr 20, 2004		DISCN	No	No
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No

Expired US Patents for apomorphine hydrochloride

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
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020

International Patents for apomorphine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2011050394	MULTI-LAYER FILM HAVING UNIFORM CONTENT
Argentina	077803	COMPOSICIONES DE PELICULA SUBLINGUALES Y BUCALES. PROCESO. METODO DE TRATAMIENTO
China	100354699

Apomorphine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Apomorphine Hydrochloride

Introduction

Apomorphine hydrochloride is a potent dopamine agonist used primarily in the treatment of Parkinson's disease, particularly for managing motor fluctuations and "off" episodes. The market for this drug is driven by several key factors, which are crucial for understanding its current and future financial trajectory.

Market Drivers

Increasing Prevalence of Parkinson's Disease

The primary driver of the apomorphine hydrochloride market is the rising global prevalence of Parkinson's disease. As the population ages and life expectancy increases, the number of individuals affected by this neurodegenerative disorder continues to grow, creating a substantial demand for effective treatment options like apomorphine hydrochloride[1][3][4].

Unique Mechanism of Action

Apomorphine hydrochloride's unique mechanism of action sets it apart from other treatments. Its ability to rapidly alleviate motor symptoms during "off" episodes, when oral dopaminergic medications become ineffective, makes it a valuable therapeutic option for patients experiencing fluctuations in their response to standard treatments[1][3].

Innovative Delivery Systems

Advancements in delivery systems, such as subcutaneous injectors and pumps, have improved patient adherence and convenience. These innovations are propelling market expansion by enhancing the efficacy and ease of use of apomorphine hydrochloride[3][4].

Market Segments and Applications

Types of Apomorphine Hydrochloride

The market is segmented based on the type of apomorphine hydrochloride, including injections, tablets, thin films, and nasal powders (which are in the pipeline). The injection segment currently accounts for a significant share of the global market and is projected to experience significant growth[3][4].

Applications

The primary application of apomorphine hydrochloride is in the treatment of Parkinson's disease. However, research is ongoing to explore its potential in treating other neurological disorders and conditions involving dopamine dysregulation, which could broaden the market scope[1][3][4].

Geographical Analysis

North America

The North American market, particularly the United States, is a significant contributor to the global apomorphine hydrochloride market. The region's well-established healthcare infrastructure, favorable reimbursement policies, and high prevalence of Parkinson's disease drive market growth in this area[1][4].

Europe

Europe is another major market, with countries like Germany, France, and the United Kingdom having a high adoption rate. The region's focus on improving patient outcomes and quality of life for Parkinson's patients has contributed to market growth[1][4].

Asia-Pacific

The Asia-Pacific region represents a rapidly growing market, driven by the increasing prevalence of Parkinson's disease, rising healthcare expenditure, and improving access to advanced treatments. Countries such as Japan, South Korea, and Australia are leading the way, while emerging markets like China and India hold significant growth potential[1][4].

Latin America and Middle East & Africa

These regions have smaller but growing markets for apomorphine hydrochloride. However, affordability and reimbursement challenges may impact market growth in certain areas[1].

Financial Trajectory

Market Size and Growth

The apomorphine hydrochloride market was valued at USD 5.12 billion in 2023 and is expected to reach USD 14.7 billion by 2031, growing at a CAGR of 11.4% from 2024 to 2031[3].

Revenue and Sales

The increasing demand for effective treatments for Parkinson's disease, coupled with advancements in delivery systems and potential new therapeutic indications, is driving revenue growth. Companies like Supernus Pharmaceuticals are focusing on expanding their product portfolios and business in the global market[2][3][4].

Challenges and Restraints

Regulatory Requirements

The use of apomorphine hydrochloride is subject to stringent regulatory requirements and clinical guidelines, which can vary across different regions. These regulations may limit market access or create barriers to entry for new products or manufacturers[1].

Reimbursement and Cost Considerations

Access to apomorphine hydrochloride treatment can be hindered by reimbursement challenges and high treatment costs, particularly in regions with limited healthcare resources or restrictive insurance coverage policies. These financial barriers can limit patient access and impact market growth[1].

Competition from Alternative Treatments

Apomorphine hydrochloride faces competition from other Parkinson's disease treatments, including alternative dopamine agonists, levodopa formulations, and emerging therapies. Ongoing research and development in the field of neurodegenerative disorders may lead to the introduction of novel treatment options, potentially impacting the market share of apomorphine hydrochloride[1].

Future Outlook

Personalized Medicine Approaches

Integrating personalized medicine approaches, such as genetic profiling or biomarker analysis, could aid in identifying patients who may benefit most from apomorphine hydrochloride treatment. Tailored treatment strategies could improve treatment outcomes and foster market growth by addressing specific patient needs[1].

Geographical Expansion

Focusing on expanding market presence in regions with high prevalence of Parkinson's disease and growing healthcare infrastructure could unlock significant growth opportunities. Strategic partnerships, local manufacturing, and targeted marketing efforts may facilitate market penetration in these regions[1].

Research and Development

Ongoing research into new therapeutic uses for apomorphine hydrochloride and the development of innovative delivery systems are expected to drive market expansion. The potential for treating additional neurological diseases is still being researched, which encourages further market growth[1][3][4].

Key Players and Competitive Landscape

Companies such as Supernus Pharmaceuticals, Britannia Pharmaceuticals, and STADA are key players in the apomorphine hydrochloride market. These companies are focusing on strategy building, product portfolio expansion, and business development to strengthen their market positions[2][4].

Key Takeaways

• The apomorphine hydrochloride market is driven by the increasing prevalence of Parkinson's disease and the need for effective treatment options.
• Innovative delivery systems and potential new therapeutic indications are propelling market growth.
• The market is segmented by type and application, with injections being a dominant segment.
• North America, Europe, and the Asia-Pacific region are significant markets, with growing potential in Latin America and the Middle East & Africa.
• Regulatory requirements, reimbursement challenges, and competition from alternative treatments are key restraints.
• Personalized medicine approaches and geographical expansion are expected to drive future growth.

FAQs

What is the primary driver of the apomorphine hydrochloride market?

The primary driver of the apomorphine hydrochloride market is the rising global prevalence of Parkinson's disease.

How does apomorphine hydrochloride differ from other Parkinson's disease treatments?

Apomorphine hydrochloride's unique mechanism of action as a potent dopamine agonist sets it apart, particularly in its ability to rapidly alleviate motor symptoms during "off" episodes.

What are the main challenges facing the apomorphine hydrochloride market?

The main challenges include stringent regulatory requirements, reimbursement and cost considerations, and competition from alternative treatments.

Which regions are expected to drive future market growth for apomorphine hydrochloride?

North America, Europe, and the Asia-Pacific region are expected to drive significant market growth, with emerging markets in Latin America and the Middle East & Africa also showing potential.

What role do innovative delivery systems play in the market growth of apomorphine hydrochloride?

Innovative delivery systems such as subcutaneous injectors and pumps have improved patient adherence and convenience, propelling market expansion.

Cited Sources:

1. DataHorizon Research: Apomorphine Hydrochloride Market Size, Share & Forecast 2033.
2. Supernus Pharmaceuticals: 25MAR201519494405 - Supernus Pharmaceuticals.
3. Market Research Intellect: Global Apomorphine Hydrochloride Market Size & Share Analysis.
4. Cognitive Market Research: Global Apomorphine Hydrochloride Market Report 2024 Edition.