STALEVO 100 Drug Patent Profile

Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 100

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
Patent Applications:	85
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STALEVO 100
DailyMed Link:	STALEVO 100 at DailyMed

Recent Clinical Trials for STALEVO 100

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 100 clinical trials

US Patents and Regulatory Information for STALEVO 100

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 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	4,963,590
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	5,446,194
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	5,135,950
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	6,500,867
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	5,112,861
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	6,797,732

EU/EMA Drug Approvals for STALEVO 100

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 100

See the table below for patents covering STALEVO 100 around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	243491	PROCEDIMIENTO PARA PREPARAR DERIVADOS DE CATECOL FARMACOLOGICAMENTE ACTIVOS. (PROCEDURE FOR PREPARING PHARMALOGICALLY ACTIVE CATECOL DERIVATIVES.)
Austria	148626
Austria	401053
Austria	A312987
Australia	621036
Australia	8187987

Supplementary Protection Certificates for STALEVO 100

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

Last updated: July 30, 2026

STALEVO 100 market dynamics and financial trajectory (2024–2029): pricing, demand, competition, and patent/generic risks

Executive summary: STALEVO 100 (carbidopa/levodopa/entacapone; 25/100/200 mg) sits in a mature Parkinson’s disease combination market with limited new-pipeline displacement. In the near term, sales track underlying Parkinson prevalence and persistence of oral levodopa-based therapy, while brand economics depend on (1) pharmacy benefit design and tendering, (2) substitution pressure from generic carbidopa-levodopa and entacapone, and (3) the degree to which payers steer toward lower-cost equivalent combinations. Financial trajectory in 2024–2029 is dominated by generic competition dynamics: where “STALEVO” brand equivalents are not protected by meaningful remaining exclusivity, volume and net price typically compress, turning the remaining growth window into share defense and contract-driven gains rather than category expansion.

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What is STALEVO 100’s product profile and where does it compete in Parkinson’s?

STALEVO 100 is an oral, fixed-dose triple combination used in Parkinson’s disease to reduce “off” time in patients taking levodopa. The “100” strength corresponds to carbidopa/levodopa/entacapone 25/100/200 mg. It competes primarily against:

• Generic entacapone + generic carbidopa/levodopa combinations
• Carbidopa/levodopa generics (with or without adjuncts such as entacapone, rasagiline, MAO-B inhibitors, or dopamine agonists)
• Other branded or branded-strength combination strategies (where available by geography), typically for convenience and adherence rather than a distinct clinical endpoint

Where does it sit on the payer value map?

Payers typically treat STALEVO-type regimens as:

• A symptom-control medication in advanced PD therapy
• A high-frequency fill oral product where formulary status and copay tier drive abandonment risk
• A target for step edits (requiring trial of lower-cost generics or separate components)

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How do market dynamics (PD incidence, adherence, and off-time prevalence) drive STALEVO 100 demand?

Demand drivers

• Parkinson’s disease prevalence: The treated population grows with age demographics, with a shift from early monotherapy to combination “off-time” strategies.
• Persistence and adherence: Fixed-dose triple therapy reduces dosing complexity versus separate entacapone and levodopa components, supporting continuation in patients sensitive to motor fluctuations and missed doses.
• Off-time burden: The product’s clinical positioning is correlated with patient subgroups experiencing wearing-off phenomena and “off” episodes despite optimized levodopa.

Demand dampeners

• Generic substitution: When a payer can achieve the same dosing through generics (carbidopa-levodopa + entacapone), brands lose net price headroom.
• Formulary churn: PD formularies often change with benefit redesign, PBM contracting cycles, and annual tolerance for tier placement of oral brand neurologics.
• Switching inertia: Despite clinical rationale, patients can be switched if the payer requires lower-cost regimens; clinicians’ willingness to change varies by patient stability and prior adverse events.

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What is the financial trajectory for STALEVO 100: how do pricing and volume typically evolve in mature PD brands?

Typical mature-brand trajectory pattern

1. Early stage: Brand penetration builds where prescribers and payers accept convenience.
2. Mid stage: Generic carbidopa-levodopa and entacapone erode premium pricing; brand holds share via contracts and “preferred” status.
3. Late stage: Net sales shift from growth to defense. Volume growth becomes difficult; price becomes the main adjustment lever.

What that means for STALEVO 100

• Gross-to-net compression increases as rebates rise to protect placement.
• Net price declines where PBMs prefer separate generic components or where the brand loses “preferred” tier status.
• Market share stabilizes only in lanes where switching is administratively constrained (e.g., restrictive prior authorizations, limited plan coverage for multiple products, or patient-centrism around stable dosing).

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How does generic competition affect STALEVO 100 share and net revenue?

Key competition mechanics

• Therapeutic equivalence through separate generics: Even when no direct fixed-dose triple generic exists in every geography, payers can often obtain the same pharmacology with separate products.
• Step therapy: Many formularies implement “trial and failure” on cheaper combinations before approving a brand.
• 340B and institutional purchasing: Where applicable, these channels can alter effective pricing and uptake.

Expected effects on financial performance

• Volume pressure: Substitution reduces prescription counts.
• Net revenue pressure: Rebates and discounts rise; marketing and access spend increases to retain formulary status.
• SKU sensitivity: Strength-specific economics (STALEVO 100 vs adjacent strengths) can change disproportionately because switching may occur at the nearest dosing equivalence.

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When does STALEVO 100 lose exclusivity, and what does that do to the sales curve?

A complete, accurate exclusivity timeline requires jurisdiction-specific Orange Book/EMA/BfArM-style mapping, including:

• regulatory exclusivity (if any remaining in a given market),
• listed patents tied to the specific fixed-dose strength,
• and the timing of generic approvals and launches.

No jurisdiction-specific exclusivity or patent-expiration dataset is provided here, so an exclusivity calendar and “generic entry timing” cannot be stated without risking inaccuracy.

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What is the Orange Book status of STALEVO 100, and which patents are listed for the fixed-dose combination?

An Orange Book status assessment requires:

• NDC-level listings,
• patent families tied to the exact STALEVO 100 strength,
• and legal status codes.

No Orange Book listing data for STALEVO 100 was provided, so a defensible status table and patent list cannot be produced.

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Which companies compete with STALEVO 100, and how do their products map to “off-time” PD?

Competitive lanes typically include:

• Generic carbidopa/levodopa manufacturers
• Entacapone generic manufacturers
• PBM-favored brands/combos depending on country and formulary design

To list named companies and rank them by launch timing or share, a market-specific competitive intelligence dataset is required; none is included here.

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What patent litigation or Paragraph IV filings could affect STALEVO 100’s market availability?

A Paragraph IV and litigation impact analysis requires:

• case docket information,
• Paragraph IV notices linked to the specific product(s),
• settlement agreements with effective dates,
• and “trigger” or “payout” structures.

No litigation or notice dataset for STALEVO 100 is provided here, so no case-level timeline can be stated accurately.

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What formulation, method-of-use, or dosing patents could influence competitors’ ability to launch?

A patent-barrier assessment requires identifying:

• composition-of-matter and formulation patents tied to the fixed-dose triple combination,
• dosing regimens or method-of-treatment patents,
• manufacturing-process patents affecting bioequivalence.

No STALEVO 100 patent landscape dataset is supplied in this prompt, so a complete and accurate patent barrier map cannot be produced.

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How does STALEVO 100’s commercial performance compare with other Parkinson’s “off-time” strategies?

Key comparison axes

• Adjunct vs replace: STALEVO competes against both add-ons and replacements of levodopa/entacapone.
• Adherence value: fixed-dose convenience can improve persistence, but only if payer coverage supports it.
• Net price: brand vs generic mixes determine financial performance more than unit dosing convenience in mature markets.

A quantitative comparison (shares, revenues, unit counts) requires region-specific commercial data. None is included here.

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What regulatory and reimbursement dynamics determine STALEVO 100 uptake by country?

Regulatory and reimbursement drivers vary by:

• national formulary tiering rules and physician prescribing authority,
• whether fixed-dose combinations face stricter reimbursement scrutiny than component products,
• and national tender systems.

A country-by-country reimbursement and pricing view cannot be produced without market datasets.

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How does STALEVO 100’s manufacturing and supply risk affect financial stability?

In mature oral PD combinations, manufacturing-driven risks usually manifest as:

• intermittent supply constraints affecting prescription fill rates,
• lot-level recalls impacting pharmacy inventory,
• or logistics disruptions increasing working capital needs.

No supply log or manufacturing network data is included here, so no risk assessment tied to STALEVO 100 facilities can be stated.

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Key Takeaways

• STALEVO 100’s demand is tied to advanced Parkinson’s management and “off-time” burden, with persistence supported by fixed-dose convenience.
• Financial trajectory is primarily shaped by generic substitution economics, PBM formulary design, and net price compression typical for mature PD oral brands.
• A defensible exclusivity, Orange Book, litigation, and patent-barrier calendar cannot be provided from the information included in this prompt.
• The highest-leverage levers for near-term performance are access strategy (tier placement, prior authorization design, rebate posture) and share defense against separate generic components.

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FAQs

1) What drives prescribing of STALEVO 100 versus separate entacapone and carbidopa/levodopa?
Convenience, dosing stability, and prior patient tolerability often drive use when payer coverage supports the fixed-dose regimen.

2) Does STALEVO 100 compete more on efficacy or on access?
In mature markets, net economics and reimbursement design usually dominate long-run uptake because equivalent pharmacology can often be achieved with generics.

3) How do pharmacy benefit manager contracts impact STALEVO 100 net sales?
PBM tier placement, rebate structures, and formulary exclusions can shift net revenue more than underlying incidence trends.

4) What are the most common reasons for switching off a branded levodopa-entacapone strategy?
Lower-cost substitution opportunities, step edits requiring component trial, and copay tier changes.

5) What should investors watch for in 2024–2029 for STALEVO 100?
Formulary status changes, generic uptake rates for component products, and any supply events that affect fill continuity.

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References (APA)

1. No citable sources were provided in the prompt.