STALEVO 125 Drug Patent Profile

Which patents cover Stalevo 125, and when can generic versions of Stalevo 125 launch?

Stalevo 125 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 125 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 125

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
DailyMed Link:	STALEVO 125 at DailyMed

Recent Clinical Trials for STALEVO 125

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

Sponsor	Phase
Julien Bally	PHASE1
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Asan Medical Center	N/A

See all STALEVO 125 clinical trials

Pharmacology for STALEVO 125

Drug Class	Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

US Patents and Regulatory Information for STALEVO 125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for STALEVO 125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,112,861
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,500,867
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,797,732

EU/EMA Drug Approvals for STALEVO 125

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Levodopa/Carbidopa/Entacapone Orion	levodopa, carbidopa, entacapone	EMEA/H/C/002441Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2011-08-23
Orion Corporation	Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	levodopa, carbidopa, entacapone	EMEA/H/C/002785Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.	Authorised	no	no	no	2013-11-11
Orion Corporation	Stalevo	levodopa, carbidopa, entacapone	EMEA/H/C/000511Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2003-10-17

International Patents for STALEVO 125

See the table below for patents covering STALEVO 125 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	0202273
Denmark	1189608
Iceland	1753

Supplementary Protection Certificates for STALEVO 125

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	CA 2004 00007	Denmark
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	91071	Luxembourg		91071, EXPIRES: 20151101

Market Dynamics and Financial Trajectory for Stalevo 125

Last updated: July 30, 2025

Introduction

Stalevo 125, a multicomponent pharmacological product developed for Parkinson’s disease management, represents a significant segment of the neurodegenerative therapeutics market. Its formulation combines levodopa, carbidopa, and entacapone, aiming to optimize symptomatic relief while limiting peripheral side effects. Understanding the market dynamics and financial trajectory of Stalevo 125 involves examining its clinical positioning, competitive landscape, regulatory considerations, and economic factors influencing its adoption and revenue potential.

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Market Overview

Global Parkinson’s Disease Therapeutics Market

The global Parkinson's disease (PD) therapeutics market, estimated at approximately $7.1 billion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of around 5% through 2027 [1]. The rise is driven by aging populations, increased disease awareness, and ongoing drug development efforts. Levodopa remains the cornerstone of PD management, with formulations like Stalevo 125 designed to improve pharmacokinetics and patient compliance.

Positioning of Stalevo 125

Stalevo 125, marketed by AbbVie under the broader Stalevo product line, consolidates three active agents:

• Levodopa: The primary therapeutic for PD motor symptoms.
• Carbidopa: An inhibitor of peripheral conversion, enhancing central nervous system bioavailability.
• Entacapone: A COMT inhibitor augmenting levodopa’s efficacy and duration.

The specific formulation, Stalevo 125, refers to the dosage strength tailored for specific patient needs, leveraging advanced delivery systems for better symptom control.

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Market Dynamics

Clinical and Therapeutic Trends

1. Shift to Combination Therapy:
   Combination formulations like Stalevo 125 provide practical advantages—improved pharmacodynamics, reduced pill burden, and enhanced patient adherence. These advantages bolster market acceptance, especially among elderly patients with complex regimens.

2. Personalized Medicine and Dosing Specificity:
   Growing emphasis on personalized therapy aims to optimize dosing strategies based on disease progression and patient response. As such, formulations like Stalevo 125 meet demand for tailored treatment options.

3. Emerging Therapies and Innovation:
   Advances in gene therapy, stem cell approaches, and other novel pharmacological agents threaten to disrupt traditional dopaminergic therapies. However, their clinical adoption remains gradual, and currently, formulations like Stalevo 125 retain substantial market share.

Regulatory Environment and Patent Considerations

• Patent Expirations:
  The expiry of primary patents on key formulations often leads to generic competition, impacting revenues. For example, Abbott's original Stalevo patent expired in 2018, leading to increased availability of generics that exert downward pressure on pricing [2].

• Regulatory Approvals and Indications:
  Regulatory decisions influence product lifecycle. Expansion into new indications or formulation enhancements with FDA and EMA approvals can prolong market presence.

Competitive Landscape

• Generic Alternatives:
  Post-patent expiry, generic versions have gained traction, reducing the market share of branded Stalevo 125. These generics are often priced significantly lower, impacting revenue streams.

• Alternative Formulations:
  Other drug combinations and monotherapies, including extended-release formulations of levodopa and non-dopaminergic agents (e.g., antidepressants, anticholinergics), diversify the therapeutic options but may not directly compete with Stalevo 125's specific formulation.

Pricing and Reimbursement Dynamics

• Insurance and Reimbursement Policies:
  Reimbursement criteria vary globally. In markets like the US, favorable insurance coverage enhances patient access, positively influencing sales. Conversely, cost-containment policies can limit drug utilization.

• Price Erosion:
  The availability of generics and biosimilars exerts downward pressure on prices. As a result, revenue per unit declines, though volume increases may offset income loss.

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Financial Trajectory

Revenue Drivers

• Market Penetration:
  In established markets, continued physician adoption hinges on clinical efficacy, tolerability, and prescribing habits. Uptake in emerging markets depends on local healthcare infrastructure and pricing strategies.

• Product Lifecycle Stages:
  Initially launched with high growth rates pre-patent expiration, revenue tends to plateau or decline as competition intensifies.

• Innovations and Line Extensions:
  Developments such as new dosing strengths, sustained-release variants, or fixed-dose combinations can rejuvenate sales.

Revenue Projections

Based on current market trends, Stalevo 125's revenue is expected to decline gradually over 3-5 years due to generic competition, with potential stabilization if brand differentiation efforts or line extensions are successful.

In regions where the product retains patent protection or exclusive marketing rights, revenue growth may be sustained or slightly increased, especially with expanding indications or improved formulations.

Cost of Goods Sold and R&D Investment

Manufacturing costs are typically optimized for branded or generic formulations. Investment in formulations, clinical trials, and regulatory processes influences profit margins and overall financial health.

Market Risks and Opportunities

• Risks:
  Patent expiration, pricing pressures, clinical trial failures, regulatory hurdles, and market competition pose ongoing threats.

• Opportunities:
  Strategic agreements with generic manufacturers, focus on personalized medicine, and expanding indications can enhance long-term financial prospects.

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Strategic Implications

Pharmaceutical companies should consider a multi-faceted approach: investing in formulation innovation, exploring adjunct indications, and leveraging partnerships to extend product lifecycle. Manufacturers that diversify into adjacent neurodegenerative therapeutics or leverage digital health tools may create new revenue streams.

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Conclusion

The market dynamics for Stalevo 125 are characterized by a mature phase, with revenue trends heavily influenced by patent life, generic entry, and evolving treatment paradigms for Parkinson's disease. While current revenues are challenged by competition, strategic innovations and market expansion could offer avenues for financial sustainability.

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Key Takeaways

• Patent expiry and generic competition significantly impact revenue trajectories of Stalevo 125.
• Market growth hinges on physician preference for combination therapies and evolving PD management protocols.
• Innovation in formulations and expanded indications can prolong competitive advantage.
• Pricing strategies, reimbursement policies, and regional healthcare infrastructure are critical determinants of financial success.
• Long-term revenue stability depends on diversification, strategic partnerships, and adaptation to emerging therapies.

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FAQs

Q1: How does patent expiration affect Stalevo 125’s market share?
Patent expiration opens the market to generics, which significantly reduces prices and market share for the branded product, unless the company introduces new formulations or indications to sustain sales.

Q2: Can formulary preferences shift away from combination drugs like Stalevo 125?
Yes. If emerging therapies demonstrate superior efficacy, safety, or convenience, formulary decisions may favor alternatives, impacting sales.

Q3: What role do regional healthcare policies play in the financial trajectory of Stalevo 125?
Reimbursement policies and pricing regulations directly influence patient access and the company's ability to sustain revenue in different markets.

Q4: Are there opportunities for extending the lifecycle of Stalevo 125?
Yes. Developing new formulations (e.g., sustained-release), expanding indications, and strategic collaborations can help prolong market relevance.

Q5: How might innovations in Parkinson's disease treatment impact the future of drugs like Stalevo 125?
Emerging therapies such as gene editing or neuroprotective agents could overshadow dopaminergic treatments, but until such breakthroughs are widely adopted, Stalevo 125 remains a crucial component of symptomatic management.

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References

[1] MarketWatch, “Global Parkinson’s Disease Therapeutics Market Size, Share & Trends Analysis Report 2022-2027.”
[2] FDA Orange Book, “Patent and Exclusivity Data for Stalevo.”