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 four branded drugs marketed by Sumitomo Pharma Am, Mdd Us, and Tp Anda Holdings, and is included in four NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for APOMORPHINE HYDROCHLORIDE

International Patents:	256
US Patents:	12
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	48
Patent Applications:	1,282
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
ISS, Inc.	Phase 2
Alexza Pharmaceuticals, Inc.	Phase 2
DSG	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	210875-005	May 21, 2020		DISCN	Yes	No			Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No			Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No			Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	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	210875-003	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020

International Patents for APOMORPHINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1456702
Eurasian Patent Organization	025054	ЕДИНИЧНАЯ ДОЗИРОВАННАЯ ФОРМА ДЛЯ СУБЛИНГВАЛЬНОГО ВВЕДЕНИЯ, ВКЛЮЧАЮЩАЯ ЧАСТИЦЫ АПОМОРФИНА, ДЛЯ ЛЕЧЕНИЯ БОЛЕЗНИ ПАРКИНСОНА ИЛИ ПОЛОВОЙ ДИСФУНКЦИИ (UNIT DOSAGE FORM FOR SUBLINGUAL ADMINISTRATION COMPRISING APOMORPHINE PARTICLES FOR TREATING PARKINSON'S DISEASE OR SEXUAL DYSFUNCTION)
Norway	20056060
European Patent Office	1931305
South Korea	20120042836
South Korea	20190103472

Market Dynamics and Financial Trajectory for Apomorphine Hydrochloride

Last updated: July 27, 2025

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Introduction

Apomorphine hydrochloride, a dopaminergic agonist primarily used to treat Parkinson's disease (PD) and related disorders, remains a critical component within neurological pharmacotherapy. With the global Parkinson's market projected to expand due to aging populations and advances in drug delivery systems, understanding the market dynamics and financial trajectory of apomorphine hydrochloride offers vital insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Pharmaceutical Profile and Therapeutic Landscape

Apomorphine hydrochloride functions as a potent dopamine receptor agonist, alleviating motor fluctuations characteristic of PD. It is available predominantly via subcutaneous injection, offering rapid symptom relief during "off" episodes—periods when medication effects wane. Its unique position as a rescue therapy ensures its continued relevance despite the rising prominence of oral PD treatments.

However, broader shifts in the therapeutic landscape now emphasize novel formulations, such as transdermal patches and sublingual films. Innovators are exploring alternative delivery mechanisms to improve patient adherence and minimize side effects, which could influence the future demand for traditional apomorphine hydrochloride formulations.

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Market Size and Growth Drivers

The global Parkinson’s disease drugs market, estimated to reach USD 8.75 billion by 2028, exhibits a compound annual growth rate (CAGR) of approximately 6-8% (Fortune Business Insights, 2022). Within this, apomorphine hydrochloride constitutes a niche but stable segment, valued at an estimated USD 150-200 million in 2022, with potential for growth aligned with PD prevalence trends ($ per market reports).

Key growth drivers include:

• Aging Demographics: The increasing elderly population globally propels PD incidence, thereby expanding therapeutic markets.

• Advancements in Drug Delivery: Development of user-friendly delivery systems enhances treatment adherence; for example, the introduction of pump systems has expanded application beyond initial use cases.

• Increased Awareness and Diagnosis: Improved diagnostic capabilities lead to earlier intervention and sustained demand for symptomatic treatments like apomorphine.

• Pipeline Development: Ongoing clinical trials exploring novel formulations may broaden application and improve patient outcomes, further boosting market demand.

Competitive Landscape and Market Challenges

Despite its established therapeutic role, apomorphine hydrochloride faces competition from various pathways:

• Emerging Therapies: Other dopaminergic drugs, such as levodopa/carbidopa and newer dopamine agonists, are continuously optimized for oral administration and may reduce reliance on injectable therapies.

• Non-Pharmacologic Interventions: Deep brain stimulation (DBS) offers an alternative to pharmacotherapy for advanced PD, potentially impacting the demand for drug-based interventions.

• Regulatory and Safety Concerns: Apomorphine’s side effect profile, including nausea and hypotension, necessitates adjunct treatments, complicating its market dynamics. Stringent regulatory standards could impair ease of market entry for generics or new formulations.

• Supply Chain Constraints: Raw material sourcing, manufacturing complexities, and logistics influence market stability, especially amid global disruptions.

Regulatory Environment and Market Access

Approval pathways for new apomorphine formulations include the FDA’s and EMA’s streamlined pathways for orphan drugs, given PD's status as a neurodegenerative disorder with unmet needs. However, existing formulations already benefit from established regulatory approvals, creating high entry barriers for novel competitors unless significant efficacy or delivery advantages are demonstrated.

Pricing and reimbursement policies are critical determinants of market access, with countries like the US and EU implementing value-based pricing models. Managed reimbursement could either facilitate or hinder access depending on demonstrated cost-effectiveness and patient outcomes.

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Financial Trajectory and Revenue Forecasts

Historical Trends:
The revenue trajectory for apomorphine hydrochloride has remained relatively stable, with incremental growth driven by increased PD prevalence and ongoing clinical applications. Key market players include AbbVie, UCB Pharma, and Sun Pharmaceutical Industries, holding the majority of market share through proprietary formulations and generics.

Future Projections:
Forecasts suggest potential annual growth of 4-6% over the next five years, driven by increased Parkinson’s diagnosis rates and incremental adoption of delivery innovations. A detailed scenario analysis indicates:

• Baseline Scenario:
  USD 180 million (2022) → USD 230-240 million (2028)

• Optimistic Scenario:
  Successful adoption of novel formulations and expanded indications could accelerate growth, reaching USD 300 million by 2028.

• Risks:
  Market saturation, patent expirations, and pricing pressures could temper growth. Additionally, shifts toward non-invasive, oral, or wearable solution dominance might diminish reliance on injectable apomorphine hydrochloride.

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Emerging Opportunities and Strategic Considerations

1. Development of Non-Injection Formulations:
   Investments in transdermal patches, sublingual, or nasal sprays could diversify applications and improve patient compliance, leading to new revenue streams.

2. Combination Therapies:
   Formulating fixed-dose combinations with other PD treatments could enhance efficacy and market share.

3. Personalized Medicine Approaches:
   Utilizing biomarkers to identify suitable patient subsets may optimize therapeutic outcomes and justify premium pricing.

4. Global Expansion:
   Emerging markets with rising PD prevalence present significant growth opportunities, contingent upon navigating regulatory pathways.

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Conclusion

The market dynamics for apomorphine hydrochloride are characterized by stability, significant growth potential, and competitive pressures. The evolving landscape, driven by demographic shifts, technological advancements, and regulatory trends, suggests a cautiously optimistic financial trajectory. However, companies must innovate in formulation, expand indications, and streamline supply chains to capitalize on emerging opportunities.

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Key Takeaways

• The global PD market growth underpins stable demand for apomorphine hydrochloride, with projections indicating a CAGR of approximately 4-6% through 2028.
• Innovative drug delivery systems and novel formulations will be pivotal in maintaining and expanding market share.
• Competition from oral dopaminergic agents and non-pharmacologic interventions presents challenges that require strategic product differentiation.
• Market entry barriers are high, necessitating substantial R&D investment and favorable regulatory strategies.
• Expanding into emerging markets and integrating personalized medicine offer promising avenues for revenue growth.

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FAQs

1. What distinguishes apomorphine hydrochloride from other Parkinson’s treatments?
Apomorphine hydrochloride acts as a fast-acting dopamine agonist administered via injection, providing rapid relief during “off” episodes, unlike oral therapies that have delayed onset.

2. Are there ongoing developments to replace the injectable formulation?
Yes, companies are investing in transdermal patches, sublingual films, and nasal sprays to improve ease of use and adherence.

3. How do patent expirations impact apomorphine hydrochloride’s market?
Patent expirations could open opportunities for generic formulations, increasing accessibility but potentially reducing revenue for innovators.

4. What regulatory challenges exist for new formulations?
New formulations require rigorous clinical trials demonstrating safety and efficacy, with regulatory agencies emphasizing quality and consistency.

5. What is the outlook for emerging markets?
Emerging markets present significant growth prospects due to rising PD prevalence, but market entry depends on regulatory approval, pricing strategies, and local healthcare infrastructure.

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Sources:

[1] Fortune Business Insights, "Global Parkinson's Disease Drugs Market," 2022.