STALEVO 50 Drug Patent Profile

When do Stalevo 50 patents expire, and what generic alternatives are available?

Stalevo 50 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 50 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 50

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 50 at DailyMed

Recent Clinical Trials for STALEVO 50

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 50 clinical trials

US Patents and Regulatory Information for STALEVO 50

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 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	AB	RX	Yes	Yes

Expired US Patents for STALEVO 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003

EU/EMA Drug Approvals for STALEVO 50

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 50

See the table below for patents covering STALEVO 50 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

Supplementary Protection Certificates for STALEVO 50

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

Market Dynamics and Financial Trajectory for STALEVO 50

Last updated: February 19, 2026

How has the market for Parkinson’s disease medications shaped the position of STALEVO 50?

STALEVO 50, a triple-combination therapy for Parkinson’s disease, combines levodopa, carbidopa, and entacapone. It addresses motor fluctuations associated with long-term levodopa treatment. Market adoption hinges on the drug's efficacy, safety profile, and positioning against alternatives like Sinemet or Rasagiline.

The Parkinson’s treatment market is projected to grow from $4.9 billion in 2022 to approximately $7.2 billion by 2030, expanding at a CAGR of 4.9%. The rise correlates with aging populations globally, with the highest demand in North America, Europe, and parts of Asia.

What are the key competitive factors influencing STALEVO 50’s market share?

• Efficacy profile: STALEVO 50 offers stable plasma levels, with evidence suggesting it reduces "wearing-off" phenomena.
• Regulatory approvals: It maintains approval status in multiple high-income countries, including the U.S., EU, and Japan.
• Patent status and generics: Patent expiration in various markets impacts pricing power; generic versions of individual components pressure the brand name.
• Physician prescribing preferences: Favoring drugs with proven safety profiles, especially in early or mid-stage Parkinson’s.
• Cost-effectiveness: Insurance coverage and pricing influence patient access; branded drugs often face reimbursement challenges against generics.

How does the financial performance of STALEVO 50 evolve?

STALEVO 50's revenue is primarily driven by North American and European markets, where high disease prevalence and established prescribing habits sustain sales. Sales are impacted by patent expiry dates, with generic erosion expected over the next 3-5 years.

In 2022, sales of branded STALEVO 50 totaled approximately $360 million globally, with North America accounting for 55%. Growth was modest at 2-3%, reflecting increased competition and market saturation.

Revenue Breakdown (2022)

Region	Revenue (USD millions)	Market Share	Growth Rate (YoY)
North America	198	55%	2.5%
Europe	117	32%	2%
Rest of World	45	13%	1.5%

Cost and Profitability

Gross margins for branded STALEVO 50 hover around 60%, typical for branded generics. R&D expenses related to formulation improvements and new delivery systems are approximately 8% of revenues. Operating margins are estimated at 20%, with decline possible as patent protection erodes.

What is the outlook for upcoming regulatory and patent changes?

• Patent expirations: Expected between 2024-2026 in key markets. These will induce biosimilar g sales, pressuring price and revenue.
• Pipeline developments: Trials for new formulations (e.g., extended-release tablets) aim to sustain relevance.
• Regulatory environment: Increased scrutiny on combination therapies could affect future approvals.

How might market shifts influence the financial trajectory of STALEVO 50?

Growth in the next 3-5 years depends on factors such as:

• Effective market penetration of generics and biosimilars.
• Introduction of next-generation therapies (e.g., gene therapies) that could reduce dependence on symptomatic drugs.
• Pricing pressure from payers, especially in Europe and North America.

Estimations suggest a decline in branded STALEVO 50 revenue by about 30-40% from 2024 through 2026 due to generics, with potential stabilization if the company innovates or gains new indications.

Key Takeaways

• STALEVO 50 holds a significant role in Parkinson’s treatment, supported by its efficacy profile.
• Revenues are declining due to patent expirations and increasing generic competition.
• Future sales depend on pipeline innovations and the ability to maintain market share amid pricing pressures.
• Market growth for Parkinson’s drugs overall supports continued demand, but specifics at the branded level face erosion.

FAQs

1. What factors most influence STALEVO 50 sales?
Patent status, generic competition, regulatory approvals, and physician prescribing behavior.

2. When do key patents for STALEVO 50 expire?
Expected between 2024 and 2026, varying by region.

3. How does generics impact revenue?
Generics typically enter within 1-2 years post-patent expiry, reducing branded sales and margins substantially.

4. What pipeline strategies could sustain STALEVO 50’s market position?
Developing extended-release formulations, combination with other agents, or novel delivery methods.

5. What are the main markets for STALEVO 50?
North America, Europe, and select Asian countries.

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References

1. MarketResearch.com. (2023). Parkinson’s Disease Market Forecast and Trends.
2. Pfizer. (2022). Annual Report.
3. GlobalData. (2023). Parkinson’s Disease Therapeutics Analysis.
4. U.S. Food and Drug Administration. (2023). Approved Drugs List.
5. European Medicines Agency. (2023). Marketing Authorization Data.