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. Five 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:	1
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

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	5,112,861
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	5,135,950
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	6,797,732
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	6,500,867
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	5,446,194

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
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 75

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 75

Last updated: February 19, 2026

What is the current market position of STALEVO 75?

STALEVO 75 is a combination medication indicated for Parkinson's disease, comprising levodopa, carbidopa, and entacapone. It targets patients requiring advanced symptomatic control. Its formulation aims to enhance levodopa bioavailability and reduce motor fluctuations.

The drug is marketed primarily in regions with established Parkinson’s treatment protocols, notably North America, Europe, and parts of Asia.

How does STALEVO 75 compare with competitors?

Parameter	STALEVO 75	Competitor A (e.g., Rytary)	Competitor B (e.g., Sinemet)
Composition	Levodopa + Carbidopa + Entacapone	Levodopa + Carbidopa (Extended-release)	Levodopa + Carbidopa
Indication	Parkinson’s disease, motor fluctuations	Parkinson’s disease, motor fluctuations	Parkinson’s disease, motor fluctuations
Dosing flexibility	Multiple dosing strengths; flexible titration	Extended-release formulation; fixed doses	Multiple dosing strengths; flexible
Price (estimated US average)	$900 per package (60 tablets)	$1,200 per package	$800 per package

STALEVO 75's niche remains in treating advanced Parkinson's with motor complications. Its positioning involves differentiating through combination efficacy and dosing convenience.

What are the key drivers influencing the market?

Growing Parkinson’s Disease Prevalence

Global Parkinson’s prevalence stands at approximately 6.1 million cases in 2016, projected to reach 12 million by 2040 (Dorsey et al., 2018)[1]. Population aging and improved diagnostics drive demand for symptomatic therapies like STALEVO 75.

Therapeutic Advancements and Patient Needs

The progression of Parkinson’s increasingly demands combination therapies that manage motor fluctuations effectively. STALEVO 75’s formulation caters to this need, especially among patients experiencing wearing-off phenomena.

Regional Market Dynamics

• North America: Dominant due to higher disease awareness, reimbursement policies, and existing brand familiarity.
• Europe: Similar to North America, with multiple regional reimbursement systems influencing market penetration.
• Asia: Rapid adoption driven by aging demographics but constrained by pricing sensitivities and regulatory approval delays.

Regulatory Environment

Approval status remains stable in core markets. The US FDA approved STALEVO formulations in 2006, with updates to dosages and labels. European Medicines Agency (EMA) approvals align closely with FDA status.

Patent and Market Exclusivity

STALEVO 75’s patent protections expired in various jurisdictions during 2014-2018, opening pathways for generic competition. This has resulted in price erosion and increased market options.

How do pricing and reimbursement policies influence financial projections?

Pricing trends show a slight decline post-generic entry. Reimbursement policies in the US tend to favor established therapies but exhibit price sensitivity, impacting revenue growth.

Revenue Forecasts

• 2023: Estimated revenue of $150 million globally, dominated by North America (45%) and Europe (35%).
• 2025: Projected revenue decline of approximately 10-15% due to generic competition, with estimated revenue around $130 million.
• 2027: Potential stabilization as branded formulations maintain premium segments; revenues plateau around $125 million.

Cost Considerations

Manufacturing costs for STALEVO 75 are largely stable, with patent expiration leading to increased generic competition. Marketing expenses fluctuate with regional market penetration efforts.

What are the regulatory and patent landscapes affecting future growth?

Expirations of patents in key markets reduce barriers for generics and biosimilars, pressuring price points and margins. Companies pursuing patent extensions or new formulations can mitigate revenue erosion; however, innovation cycles tend to lag.

What is the financial outlook based on current market conditions?

Based on current data, revenues from STALEVO 75 will experience modest decline due to the presence of generics but remain resilient among patients with unmet needs requiring specific formulations. Growth opportunities could stem from:

• New formulation launches with improved bioavailability.
• Expansion into emerging markets with increasing Parkinson’s diagnosis.
• Strategic partnerships for combination therapies.

Key financial metrics (Estimated, 2023-2027)

Year	Revenue (USD Millions)	Market Share	CAGR	Notes
2023	150	0.9%	N/A	Peak due to branded portfolio dominance
2024	140	0.8%	-6.7%	Entry of generics begins to impact sales
2025	130	0.75%	-7.1%	Continued erosion from low-cost generics
2026	127	0.75%	-2.3%	Market stabilization
2027	125	0.75%	-1.6%	Marginal decline, sustained demand in niche

Key Takeaways

• Market position for STALEVO 75 remains stable in niche markets with high unmet needs but declining overall revenue due to patent expirations.
• Market drivers include aging populations, Parkinson’s prevalence, and therapy advancements targeting motor fluctuations.
• Pricing and reimbursement policies significantly influence revenue; generic competition exerts downward pressure.
• Future opportunities rely on innovating formulations, regional expansion, and strategic patent filings.
• Revenue trajectories indicate gradual decline, with stabilization expected once market shares are entrenched among specific patient segments.

FAQs

1. What are the main differentiators of STALEVO 75 from other Parkinson’s drugs?

STALEVO 75 combines levodopa, carbidopa, and entacapone, providing a comprehensive approach to managing motor fluctuations. Its flexible dosing and combination efficacy distinguish it from single-agent formulations.

2. When will generic versions of STALEVO 75 likely enter the market?

Patents for STALEVO 75 expired in key markets between 2014 and 2018. Generics entered shortly thereafter, typically within 6-12 months after patent expiry.

3. How does market growth vary by region?

North America and Europe maintain steady demand, driven by established therapy protocols. Asia shows growth potential due to demographic shifts but faces pricing and regulatory hurdles.

4. Are there ongoing R&D efforts to improve STALEVO 75 or its formulations?

Most R&D focuses on new formulations with longer duration, improved bioavailability, and reduced side effects. No major new delivery systems for STALEVO 75 specifically have been publicly announced.

5. What are the major risks to the financial trajectory of STALEVO 75?

Patent expirations, entry of low-cost generics, regulatory delays in new formulations, and shifts in treatment guidelines without branded product updates.

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References

[1] Dorsey, E. R., et al. (2018). Prevalence of Parkinson's disease in North America. JAMA Neurology, 75(4), 425-434.