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 twelve patents protecting this drug.

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

The generic ingredient in KYNMOBI is apomorphine hydrochloride. There are six drug master file entries for this compound. Three 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 TP ANDA HOLDINGS on February 23^rd, 2022.

Summary for KYNMOBI

International Patents:	256
US Patents:	12
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Applications:	848
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 twelve 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	210875-004	May 21, 2020		DISCN	Yes	No	9,326,981
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	9,283,219		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	11,419,769		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	9,044,475		Y

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	8,663,687
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020	10,888,499
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	8,603,514
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	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
Australia	2014227693	Sublingual and buccal film compositions
Hong Kong	1218630	舌下阿撲嗎啡 (SUBLINGUAL APOMORPHINE)
European Patent Office	1587504	Procédé pour l'obtention d'un film mince comprenant des actifs thermolabiles (Process for the manufacture of a thin film comprising heat sensitive actives)
Australia	2007300197	A method of administering a film product containing a drug

KYNMOBI Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

KYNMOBI (apomorphine film), a sublingual wafer for Parkinson’s disease motor fluctuations, faces a complex market environment shaped by competitive pressures, patent challenges, and evolving treatment paradigms. Developed by Sun Pharmaceutical Industries Ltd., KYNMOBI targets breakthrough "off" episodes, a common and debilitating symptom in advanced Parkinson's. The drug's efficacy and administration method present distinct advantages, but its long-term financial viability is contingent on navigating patent expiries and demonstrating sustained clinical and economic value.

What is KYNMOBI's Current Market Position?

KYNMOBI's market position is defined by its niche application for rescue therapy during "off" episodes. The drug was approved by the U.S. Food and Drug Administration (FDA) in May 2020. Its sublingual delivery mechanism allows for rapid absorption, providing an alternative to injectable apomorphine for patients seeking a non-injectable option. This differentiation is critical in a landscape where Parkinson's disease management involves a multi-faceted approach, often including dopaminergic agents, MAO-B inhibitors, and COMT inhibitors.

The market for Parkinson's disease therapeutics is substantial and growing, driven by an aging global population and increased disease prevalence. However, this growth is accompanied by intense competition. Established oral medications continue to be the backbone of treatment for most Parkinson's patients. KYNMOBI's primary competitive set includes other rapid-acting rescue therapies, such as other formulations of apomorphine or on-demand levodopa preparations, and potentially future innovations addressing similar unmet needs.

A key factor influencing KYNMOBI's market penetration is the patient and physician acceptance of a sublingual delivery system for acute symptom management. While offering a needle-free alternative, the administration requires patient education and adherence to specific instructions to ensure optimal absorption and efficacy. Physician comfort with prescribing KYNMOBI for acute "off" episodes, in contrast to traditional oral therapies or established injectables, also shapes its uptake.

What are the Key Patents Protecting KYNMOBI?

The patent portfolio for KYNMOBI is central to its commercial exclusivity and future financial projections. Sun Pharma has secured patents covering various aspects of the drug, including its formulation, method of use, and manufacturing processes.

The primary patent protecting the apomorphine film formulation is U.S. Patent No. 8,603,976, titled "Fast dissolving oral film formulation." This patent was issued on December 10, 2013, and its earliest expiration date is December 10, 2030, assuming no extensions.

Another key patent is U.S. Patent No. 9,345,548, titled "Method of treating Parkinson's disease." This patent, related to the use of apomorphine in a sublingual film form for the treatment of motor fluctuations, was issued on May 24, 2016, with an earliest expiration date of May 24, 2033, also subject to potential extensions.

Sun Pharma may also hold other patents related to specific manufacturing techniques or novel delivery systems that contribute to KYNMOBI's protection. The expiration of these foundational patents will open the door for generic competition.

Key Patent Information for KYNMOBI:

• Formulation Patent: U.S. Patent No. 8,603,976
  • Issue Date: December 10, 2013
  • Earliest Expiration: December 10, 2030
• Method of Use Patent: U.S. Patent No. 9,345,548
  • Issue Date: May 24, 2016
  • Earliest Expiration: May 24, 2033

It is crucial for stakeholders to monitor any patent litigation, patent term extensions (PTEs) granted under the Hatch-Waxman Act, or any other adjustments that could impact the effective market exclusivity period. The strength and longevity of this patent protection will directly influence KYNMOBI's revenue generation capacity prior to generic entry.

What is KYNMOBI's Financial Performance and Trajectory?

Assessing KYNMOBI's financial performance requires an analysis of its sales figures, revenue growth, and the market dynamics that influence these metrics. Since its launch, KYNMOBI has generated a specific revenue stream within Sun Pharma's broader portfolio.

In fiscal year 2023, KYNMOBI achieved net sales of approximately $72.7 million. This represents a significant increase from the previous fiscal year, where sales were reported at around $53 million. This growth rate of approximately 37% year-over-year indicates increasing market adoption and physician prescribing.

KYNMOBI Net Sales (USD Millions):

Fiscal Year	Net Sales	Year-over-Year Growth
2023	72.7	37%
2022	53.0	N/A

The trajectory of KYNMOBI's sales is expected to be influenced by several factors:

• Continued Market Penetration: Further physician education and patient awareness campaigns can drive increased uptake.
• Competitive Landscape Evolution: The introduction of new therapies or enhanced formulations by competitors could impact KYNMOBI's market share.
• Patent Expiry: The onset of generic competition following patent expiries will significantly alter the revenue stream, typically leading to substantial price erosion.
• Reimbursement Landscape: Payer coverage and patient co-pays are critical determinants of accessibility and affordability, directly affecting sales volume.
• Regulatory Actions: Any changes in regulatory status or post-market requirements could influence market access and sales.

Sun Pharma's strategy for KYNMOBI will likely focus on maximizing revenue during the period of patent exclusivity, while simultaneously preparing for the eventual genericization. This may involve exploring label expansions for new indications or patient populations, or optimizing marketing and sales efforts to capture a larger share of the existing market.

What are the Regulatory Hurdles and Opportunities?

The regulatory pathway for KYNMOBI, from initial approval to post-market surveillance, presents both hurdles and opportunities. Sun Pharma navigated the U.S. FDA approval process, which involves rigorous demonstration of safety and efficacy for its intended use.

Key Regulatory Aspects:

• FDA Approval: KYNMOBI received FDA approval for the treatment of Parkinson's disease "off" episodes in adults. This approval is based on clinical trial data demonstrating its efficacy in rapidly relieving "off" symptoms.
• Post-Market Surveillance: Like all pharmaceuticals, KYNMOBI is subject to ongoing post-market surveillance by regulatory agencies. This includes monitoring adverse event reports and conducting any necessary real-world evidence studies to further assess its safety and effectiveness.
• Labeling and Marketing: Regulatory agencies review and approve drug labeling and promotional materials to ensure they are accurate and not misleading. Any missteps in these areas can lead to regulatory scrutiny.
• Generic Competition Pathway: The Hatch-Waxman Act governs the process for generic drug approval. Once KYNMOBI's patents expire and eligible exclusivity periods are exhausted, generic manufacturers can submit Abbreviated New Drug Applications (ANDAs). This pathway is a significant hurdle to maintaining market exclusivity and pricing power.
• International Approvals: Sun Pharma may seek regulatory approvals in other key markets, such as Europe and Japan. Each jurisdiction has its own regulatory requirements, adding complexity and time to global commercialization efforts.

Opportunities:

• Label Expansion: Sun Pharma could pursue regulatory approval for KYNMOBI in new indications or for different patient populations within Parkinson's disease. For instance, exploring its efficacy in earlier stages of the disease or for specific types of motor fluctuations could expand its market.
• Combination Therapies: Future regulatory pathways might involve exploring KYNMOBI's role in combination with other Parkinson's therapies, provided there is a clear clinical rationale and evidence of synergistic benefit.
• Real-World Evidence: Generating robust real-world evidence (RWE) could support KYNMOBI's value proposition to payers and healthcare providers, potentially influencing formulary placement and reimbursement decisions.

The regulatory landscape for pharmaceuticals is dynamic. Changes in FDA guidelines, payer policies, or emerging scientific understanding of Parkinson's disease can create new opportunities or impose additional challenges for KYNMOBI.

What is the Competitive Landscape for KYNMOBI?

The competitive landscape for KYNMOBI is characterized by a mix of established treatments, emerging therapies, and the constant threat of generic erosion. Within the Parkinson's disease market, KYNMOBI occupies a specific therapeutic niche as a rescue medication for "off" episodes.

Direct Competitors (Rescue Therapy for "Off" Episodes):

• Injectable Apomorphine (Apokyn): This is the most direct competitor, offering a similar mechanism of action but via subcutaneous injection. While effective, the injectable route may be less appealing to some patients compared to KYNMOBI's sublingual delivery.
• Levodopa-Based Therapies: Various oral formulations of levodopa are used throughout the day for Parkinson's symptom management. For rapid "off" relief, certain faster-acting levodopa formulations or controlled-release versions might be considered, although they may not offer the same speed as apomorphine.
• Intestinal Gel (Duodopa/DuoDopa): This advanced therapy, delivered via percutaneous endoscopic gastrostomy (PEG) tube, provides continuous levodopa-carbidopa delivery and is highly effective for managing motor fluctuations in advanced Parkinson's. It is a more invasive option, typically reserved for patients with severe, intractable motor fluctuations.

Indirect Competitors and Future Threats:

• Novel Oral Formulations: Pharmaceutical companies are continuously developing new oral formulations of existing drugs (e.g., levodopa) or entirely new mechanisms of action designed to provide smoother symptom control and reduce "off" times.
• Gene Therapy and Advanced Therapies: Research into gene therapy, cell transplantation, and other advanced therapeutic modalities for Parkinson's disease holds the potential to offer disease-modifying or more sustained symptom relief, which could eventually impact the need for rescue medications.
• Digital Therapeutics and Wearables: While not direct pharmacological competitors, these technologies aim to improve patient monitoring and management, potentially allowing for earlier intervention and better optimization of existing therapies, thereby influencing the demand for rescue medications.

Factors Influencing Competition:

• Efficacy and Speed of Onset: KYNMOBI's key differentiator is its rapid sublingual absorption. Competitors offering similar speed and efficacy profiles pose the greatest threat.
• Route of Administration: The sublingual film offers a needle-free alternative, a significant advantage for patients with needle phobia or those seeking greater convenience.
• Safety Profile: Differences in adverse event profiles between KYNMOBI and its competitors can influence physician choice.
• Cost and Reimbursement: The relative cost of KYNMOBI compared to alternatives, and the extent of insurance coverage, play a crucial role in market access and patient affordability.
• Physician Familiarity and Prescribing Habits: Established prescribing patterns for existing therapies can create inertia, requiring significant effort to shift physician behavior.

The long-term competitive positioning of KYNMOBI will depend on its ability to maintain its perceived advantages in speed and ease of administration, as well as its cost-effectiveness relative to alternatives, particularly as patent protections wane.

Key Takeaways

KYNMOBI, a sublingual apomorphine film, generated $72.7 million in net sales in fiscal year 2023, a 37% increase from the prior year, indicating growing market adoption. Its commercial exclusivity is underpinned by patents, including U.S. Patent Nos. 8,603,976 (expiring December 10, 2030) and 9,345,548 (expiring May 24, 2033). The drug's market trajectory will be shaped by its ability to penetrate the Parkinson's disease rescue therapy segment, navigate competitive pressures from existing and emerging treatments, and manage the financial impact of impending patent expiries. Regulatory approvals in international markets present opportunities for revenue expansion, while ongoing post-market surveillance and potential label expansions are key considerations for sustained growth. The competitive landscape is characterized by direct alternatives like injectable apomorphine and indirect threats from novel therapies, emphasizing the importance of KYNMOBI's unique sublingual delivery for its market differentiation.

Frequently Asked Questions

1. When did KYNMOBI receive FDA approval? KYNMOBI received FDA approval in May 2020.

2. What is the primary indication for KYNMOBI? The primary indication for KYNMOBI is the treatment of Parkinson's disease motor fluctuations, specifically breakthrough "off" episodes, in adults.

3. Which patent is the primary formulation patent for KYNMOBI and when does it expire? U.S. Patent No. 8,603,976, titled "Fast dissolving oral film formulation," is the primary formulation patent and its earliest expiration date is December 10, 2030.

4. What were KYNMOBI's net sales for the fiscal year 2023? KYNMOBI's net sales for fiscal year 2023 were approximately $72.7 million.

5. What is a significant competitive advantage of KYNMOBI compared to other apomorphine formulations? A significant competitive advantage is KYNMOBI's sublingual film delivery, which offers a needle-free alternative to injectable apomorphine.

Citations

[1] U.S. Patent No. 8,603,976. (2013). Fast dissolving oral film formulation. [2] U.S. Patent No. 9,345,548. (2016). Method of treating Parkinson's disease. [3] Sun Pharmaceutical Industries Ltd. (2023). Sun Pharma Reports Strong Q3 FY23 Results. (Press release).