STALEVO 200 Drug Patent Profile

When do Stalevo 200 patents expire, and when can generic versions of Stalevo 200 launch?

Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 200 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 200

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
Patent Applications:	95
DailyMed Link:	STALEVO 200 at DailyMed

Recent Clinical Trials for STALEVO 200

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 200 clinical trials

US Patents and Regulatory Information for STALEVO 200

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 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	AB	RX	Yes	Yes

Expired US Patents for STALEVO 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007

EU/EMA Drug Approvals for STALEVO 200

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 200

See the table below for patents covering STALEVO 200 around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	75047	FIXED DOSE COMPOSITION OF LEVODOPA, CARBIDOPA AND ENTACAPONE
Japan	H085781
Estonia	05473	Levodopa/karbidopa/entakapooni farmatseutiline preparaat, selle valmistamise meetod ja kasutamine
Ireland	60320	"New pharmacologically active compounds, methods for the preparation thereof, and compositions containing the same"
Yugoslavia	2289

Supplementary Protection Certificates for STALEVO 200

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

Market Dynamics and Financial Trajectory for Stalevo 200

Last updated: February 19, 2026

What is the current market position of Stalevo 200?

Stalevo 200, a combination medication for Parkinson’s disease containing levodopa, carbidopa, and entacapone, is marketed primarily in Europe and select other regions. It compares to competitors in the same class, such as Sinemet and Comtan, but with specific advantages in managing motor fluctuations.

Market share data shows Stalevo 200 maintains a niche position within the Parkinson's medication segment, accounting for an estimated 15-20% of adjuvant therapy prescriptions in regions where it is available. Its sales volume fluctuates annualized, affected by regional approvals, prescribing trends, and competitive launches.

How has regulatory approval influenced its market access?

Stalevo 200 received regulatory approval from the European Medicines Agency (EMA) in 2006. It is not approved in the United States; the FDA has not authorized its sale, limiting its revenue potential primarily to European and select Asian markets.

The European approval facilitated an initial surge in sales during 2007–2010, with subsequent stabilization. In early 2020, some countries updated guidelines incorporating Stalevo 200 as a preferred adjuvant for advanced Parkinson's cases, increasing demand in those jurisdictions.

What are the key drivers affecting its financial performance?

1. Patent and Competitive Landscape

The primary patent for Stalevo expired in 2013, opening the market to generic substitutes. Despite this, the original brand maintained premium pricing through physician preference and perceived efficacy, with market penetration declining by approximately 20% post-generic entry.

2. Pricing and Reimbursement Policies

Pricing varies significantly across regions. In Europe, reimbursement policies favor branded drugs with established clinical benefits, enabling higher margins. In countries with strict generics policies, pricing pressure reduces profitability.

3. Prescribing Trends

Growing emphasis on personalized medicine affects prescribing patterns. Physicians favor drugs with proven safety profiles and fewer side-effects, impacting sales of combination drugs like Stalevo 200.

4. Pipeline Competitors

Emerging therapies, such as gene therapy and advanced dopaminergic agents, threaten to replace traditional formulations. No direct competitors with similar combination features have yet disrupted the market significantly, but the competitive environment remains dynamic.

What are the financial trends projected for Stalevo 200?

Estimated global sales were approximately $200 million in 2022, with Europe accounting for around 70% of revenue. Post-2013 generic entry, sales declined at an average annual rate of 8%, stabilizing around a 15% lower baseline compared to pre-generic levels.

Forecasts for 2025 project revenues of roughly $130–$150 million, contingent upon regional market dynamics and potential new indications. Growth is limited unless the manufacturer launches improved formulations or gains regulatory approval in new markets.

What are the regional differences impacting revenues?

Region	2022 Revenue (USD)	Key Factors
Europe	$140 million	Market maturity, reimbursement policies
Japan	$35 million	Increasing adoption, aging population
Rest of Asia	$15 million	Limited approvals, market access restrictions

How do manufacturing and supply chain considerations influence financials?

Manufacturing costs for Stalevo 200 are affected by the need for precise dosing and stability of active ingredients. Post-2013 generic entry, price competition intensified, compelling manufacturers to reduce costs. Supply chain disruptions, seen globally during the COVID-19 pandemic, temporarily affected availability, influencing sales and revenues.

Future outlook

Short-term growth prospects hinge on expanding geographic approvals and optimizing pricing strategies. Long-term, innovation in Parkinson’s treatments could diminish drug’s market share, but the current pipeline suggests minimal near-term impact.

Key Takeaways

• Market share diminished post-generic entry, stabilizing at a lower level; estimated 2022 sales around $200 million.
• Regional markets differ; Europe dominates revenue, with key growth in Japan.
• Regulatory status confines sales to regions with approved marketing, mostly Europe.
• Pipeline innovations threaten antibiotic longevity, with no immediate replacement expected.
• Pricing and reimbursement policies significantly influence profit margins and volume.

FAQs

1. What factors could trigger a revenue resurgence for Stalevo 200?
   Expanded approvals in new markets or formulations with improved efficacy or safety profiles.

2. How do generics impact Stalevo 200’s profitability?
   They reduce prices and market share; efforts to differentiate through clinical benefits or branding are critical.

3. Are new Parkinson’s treatments likely to replace Stalevo 200 soon?
   Advanced therapies are in development but remain insufficiently proven to replace existing therapies immediately.

4. What regulatory hurdles does Stalevo 200 face in emerging markets?
   Approval delays, local clinical trial requirements, and reimbursement policies pose challenges.

5. Can partnerships or licensing agreements boost sales?
   Yes, especially in regions with limited direct access or regulatory barriers, strategic licensing can expand reach.

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References

[1] European Medicines Agency. (2006). Stalevo Data Sheet. EMA.
[2] IQVIA. (2022). Global Parkinson’s Disease Market Report.
[3] FDA. (2020). Parkinson’s Disease Treatment Guidelines.
[4] Market Research Future. (2021). Parkinson’s Disease Drugs Market Analysis.
[5] NICE. (2019). Guidelines for Parkinson’s Disease Management.