STALEVO 75 Drug Patent Profile

When do Stalevo 75 patents expire, and when can generic versions of Stalevo 75 launch?

Stalevo 75 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 75 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 75

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
DailyMed Link:	STALEVO 75 at DailyMed

Recent Clinical Trials for STALEVO 75

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 75 clinical trials

Pharmacology for STALEVO 75

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

US Patents and Regulatory Information for STALEVO 75

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 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for STALEVO 75

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008

EU/EMA Drug Approvals for STALEVO 75

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 75

See the table below for patents covering STALEVO 75 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	0202273
Denmark	1189608
Iceland	1753
Israel	146807	LEVODOPA/CARBIDOPA/ENTACAPONE PHARMACEUTICAL PREPARATION
South Africa	8708953
Hong Kong	1047040
Poland	197818

Supplementary Protection Certificates for STALEVO 75

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
0426468	0490007-2	Sweden		PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: STALEVO 75

Last updated: July 28, 2025

Introduction

STALEVO 75, marketed primarily by Novartis, is a combination therapy used in the management of Parkinson’s disease. Its unique formulation integrates levodopa, carbidopa, and entacapone to offer symptomatic relief and enhanced motor function. As a critical entrant in the Parkinson’s pharmacological landscape, STALEVO 75’s market performance hinges on evolving clinical, regulatory, and competitive factors influencing its growth trajectory. This analysis explores the market dynamics and financial outlook shaping STALEVO 75's future.

Market Overview and Therapeutic Significance

Parkinson’s disease (PD), affecting approximately 10 million individuals worldwide, necessitates long-term symptomatic management [1]. Levodopa remains the gold-standard treatment, with adjuncts like carbidopa and entacapone enhancing bioavailability and efficacy. STALEVO 75's fixed-dose combination offers convenience, improved compliance, and pharmacokinetic benefits over monotherapy.

The global PD drug market is projected to reach USD 8.2 billion by 2027, growing at a CAGR of around 6% (2022–2027) [2]. Within this sphere, oral levodopa formulations constitute the majority share, with combination therapies like STALEVO 75 capturing increasing attention due to their tailored efficacy profiles.

Competitive Landscape and Market Dynamics

1. Evolving Therapeutic Paradigms

While levodopa remains central, the advent of novel agents—such as dopamine agonists, MAO-B inhibitors, and gene therapies—alter the treatment landscape's dynamics [3]. Consequently, the demand for fixed-dose formulations like STALEVO 75 faces competitive pressures from newer delivery systems and combination therapies offering improved convenience or reduced side effects.

2. Regulatory Environment and Patent Litigation

Patent expiration timelines significantly influence market access. Novartis’s patent exclusivity for STALEVO 75 is approaching, with generic competitors potentially entering the market. Patent cliffs typically precipitate revenue declines, though lifecycle extensions via new formulations or indications can mitigate this.

3. Pricing and Reimbursement Trends

Healthcare reforms globally are emphasizing cost containment. Pricing pressures, particularly in European and North American markets where STALEVO 75 is well established, threaten profit margins. Reimbursement policies increasingly favor cost-effective therapies, emphasizing the importance of demonstrating clinical value and adherence benefits.

4. Geographic Market Penetration

Developed markets—especially North America and Western Europe—remain dominant for STALEVO 75, supported by aging populations and high prevalence rates. However, emerging markets, including Asia-Pacific and Latin America, present growth opportunities driven by expanding healthcare infrastructure and increasing PD diagnoses [4].

5. Patient Compliance and Preference

Simplified regimens improve adherence rates, which are critical in PD management. STALEVO 75’s fixed-dose approach aligns with these preferences, supporting sustained prescription rates. However, factors such as side effect profiles and individualized dosing may influence its adoption.

Financial Trajectory and Revenue Forecasts

Historical Performance

Novartis reported that STALEVO (including various strengths) generated approximately USD 600 million annually prior to patent expiry pressures [5]. As patents for core formulations near expiration, revenue streams are expected to plateau or decline.

Projection Factors

• Patent Expiry and Generics: Generics are anticipated to erode market share, with the extent dependent on patent litigation outcomes and regulatory approvals [6].

• Pipeline Alternatives: The development of novel therapies (e.g., gene modulation, extended-release formulations) may either cannibalize STALEVO 75 sales or open adjunct markets.

• Increased Diagnosis and Aging Population: Growth in PD prevalence sustains demand, particularly in emerging economies. If expansion occurs without competitive erosion, revenues may stabilize or grow modestly.

• Market Penetration Strategies: Novartis’s efforts to expand indications, improve formulations, or enhance delivery methods can influence future earnings positively.

Estimated Financial Trajectory (2023–2028):

Year	Estimated Revenue (USD Millions)	Notes
2023	400 – 450	Post-patent expiry, market share decline begins
2024	350 – 400	Generic competition intensifies
2025	300 – 350	Adoption of biosimilars impacts sales
2026	250 – 300	Market saturation, pipeline impact
2027	200 – 250	Lower revenues; potential niche dominance

Note: These projections are speculative, based on patent expiry trends, competitive landscape, and market growth assumptions.

Regulatory and Market Expansion Opportunities

1. New Indications and Formulations

Expansion into early-stage PD management or adjunct indications could create additional revenue streams. Extended-release formulations or transdermal patches could enhance adherence and justify premium pricing.

2. Strategic Collaborations

Partnering with biotech firms exploring gene therapies or neuroprotective agents can facilitate integrated treatment approaches, potentially sustaining revenues.

3. Geographic Expansion

Targeted strategies in high-growth regions like Asia-Pacific and Latin America, where PD prevalence is rising, could offset declines in mature markets.

4. Digital Health and Monitoring

Integration of digital adherence tools and remote monitoring can enhance treatment outcomes, supporting premium positioning and market differentiation.

Implications for Stakeholders

• Pharmaceutical Companies: Must strategize around patent lifecycle management, pipeline diversification, and geographic expansion to sustain revenue.

• Investors: Should monitor patent statuses, pipeline developments, and market entry barriers in emerging economies for informed decisions.

• Healthcare Systems: Cost containment measures necessitate demonstrating the clinical and economic value of STALEVO 75, especially as generics flood the market.

Conclusion

The financial trajectory of STALEVO 75 will be shaped predominantly by patent expirations, competitive dynamics, and market expansion strategies. While near-term revenues face pressure from generic substitution and evolving therapies, opportunities exist through pipeline innovations, geographic penetration, and value-based healthcare strategies. A nuanced understanding of these variables enables stakeholders to optimize product positioning and investment decisions.

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Key Takeaways

• Patent expiration will substantially impact STALEVO 75’s market share, necessitating strategic diversification.

• Market competition from generics and alternative therapies underscores the importance of differentiation through formulation and clinical value.

• Emerging markets provide growth avenues despite challenges posed by pricing and reimbursement policies.

• Pipeline innovations and indications expansion are critical to maintaining long-term revenue streams.

• Digital health integration offers avenues for improved adherence and value demonstration, reinforcing competitive advantage.

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FAQs

1. When is the patent expiration for STALEVO 75, and what are its implications?
The primary patent for STALEVO 75 is expected to expire around 2024–2025. This expiration allows generic manufacturers to introduce competing products, likely leading to significant revenue declines unless Novartis introduces new formulations or indications.

2. How does the competitive landscape impact STALEVO 75's market share?
The entry of generics, biosimilars, and emerging therapies compresses market share for branded formulations. To mitigate this, Novartis focuses on patient adherence, extended indications, and geographic expansion.

3. What is the potential for growth in the emerging markets?
Rapidly growing healthcare infrastructures, increasing PD diagnosis rates, and favorable regulatory environments create significant growth opportunities, although price sensitivity remains a challenge.

4. Are there ongoing pipeline developments that could offset revenue decline?
Yes, Novartis and other pharma entities are exploring extended-release formulations, adjunct therapies, and gene-focused treatments, which could supplement or replace current sales.

5. How can stakeholders ensure continued profitability for STALEVO 75?
Through lifecycle management strategies including innovation, geographic diversification, partnership collaborations, and leveraging digital health for improved outcomes.

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References

1. Parkinson’s Foundation. Parkinson’s Disease Statistics. https://www.parkinson.org
2. MarketsandMarkets. Parkinson’s Disease Therapeutics Market. 2022.
3. Schapira, A. H. V., et al. “Emerging therapies for Parkinson's disease.” Nature Reviews Drug Discovery, 2020.
4. World Health Organization. Parkinson’s Disease Fact Sheet. 2021.
5. Novartis Annual Reports. 2022.
6. U.S. FDA Patent and Exclusivity Data. 2023.