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
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
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
Belgium	1003279	NOUVEAUX COMPOSES PHARMACOLOGIQUEMENT ACTIFS, LEURS PROCEDES DE PREPARATION ET LES COMPOSITIONS EN CONTENANT.

Supplementary Protection Certificates for STALEVO 75

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 29, 2026

STALEVO 75 market dynamics and financial trajectory: exclusivity, competition, and revenue outlook

Executive summary: STALEVO 75 (carbidopa/levodopa/entacapone, 75/18.75/200 mg) is a late-life, combination product within the Parkinson’s disease (PD) portfolio. Market dynamics are dominated by (1) aging indication penetration, (2) substitution to other levodopa-carbidopa-entacapone options and COMT inhibitors, and (3) payer-driven switching toward preferred generics where available. Financial trajectory is expected to track the product’s U.S. exclusivity and patent expiration calendar and the speed of generic entry once Orange Book barriers clear. The commercial base is also sensitive to neurologist prescribing patterns and institutional formularies, where dosing convenience (interval control and tablet strengths) can delay switching even when label-level competition is present.

The remainder below maps the most relevant market and financial drivers for STALEVO 75: competitive set, reimbursement incentives, exclusivity and IP risk to generic entry, and the likely revenue shape over the next exclusivity-to-generic transition window.

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What is STALEVO 75 and how does it fit into Parkinson’s disease treatment sequencing?

Short answer: STALEVO 75 is a fixed-dose oral combination used in PD patients who require levodopa plus adjunct COMT inhibition to extend levodopa effect and reduce “off” time. It is positioned after baseline levodopa-carbidopa therapy, either when catechol-O-methyltransferase (COMT) inhibition is added or when patients are consolidated onto a single multi-drug tablet regimen.

How do clinicians choose among STALEVO strengths and regimens?

Clinicians typically select based on:

• Levoda dose titration needs (75 mg levodopa strength supports mid-range dosing adjustments).
• Dosing frequency and the patient’s dyskinesia and wearing-off profile.
• Tablet consolidation goals for adherence.
• Switch tolerance and history of COMT inhibitor response.

Key payer levers in “off time” therapy

Payers often shift toward:

• Preferred COMT inhibitor regimens (including generic entacapone-based approaches where available).
• Step edits requiring prior use of levodopa-carbidopa before approving combination products.
• Quantity limits aligned with typical dosing ranges.

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What market dynamics drive demand for STALEVO 75 in the US and major EU markets?

Featured snippet answer: Demand is driven by PD prevalence, levodopa durability, adherence to fixed-dose combinations, and payer policies that favor generics once patent barriers clear.

Demand drivers

1. Chronic, stable but aging population
   • PD prevalence rises with age, but most levodopa treated patients remain on long-term regimens rather than switching rapidly.
2. Wearing-off management
   • STALEVO’s COMT inhibition targets symptom fluctuations, which supports ongoing use for eligible patients.
3. Formulary placement
   • Where STALEVO is non-preferred, switching accelerates with generic availability and price pressure.

Demand drags

• Generic erosion risk once barriers clear for any substituted dosing strength.
• Therapy migration
  • Some patients shift toward dopamine agonist-avoidance strategies, extended-release levodopa formulations, or newer adjuncts depending on patient-specific adverse-effect tolerability.
• Institutional formularies and copay pressure
  • Out-of-pocket costs can move patients to covered alternatives even when clinically appropriate options exist.

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What exclusivity and patent timeline determines when STALEVO 75 revenue is exposed to generic entry?

Short answer: The financial trajectory hinges on the U.S. Orange Book patent estate and the last exclusivity anchor for the specific formulation strengths. Once paragraph IV ANDA and litigation resolve, generic entry can compress prices quickly across the strength range through therapeutic and dosing interchangeability.

Where revenue typically peaks and then declines

• Pre-generic period: revenue is supported by brand pricing power plus patient inertia.
• First generic launch: gross-to-net compression begins immediately via rebate and payer pressure.
• Post-2nd/3rd generic: additional price compression and incremental market share dilution occurs.
• Larger class substitution: if multiple COMT inhibitor/generic combinations become preferred, the brand can lose share faster than expected from simple patent expiry timing.

How STALEVO 75 strength-specific entry can unfold

Because STALEVO is sold in multiple strengths, the launch of a generic for one strength can trigger substitution across strengths if:

• tablets are dose-interchangeable in common regimens,
• prescribers are willing to titrate using available strengths,
• payers prefer the lowest acquisition cost per levodopa equivalent.

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What is the competitive landscape for STALEVO 75: who challenges and how?

Short answer: The competitive set includes (1) brand competitors for adjunct “off” time management, (2) generic levodopa-carbidopa-entacapone options where available, and (3) alternative adjunct strategies that reduce reliance on COMT inhibition.

Direct substitutes

• Generic carbidopa/levodopa/entacapone products (where marketed for PD adjunct therapy with equivalent composition).
• Separate components strategy (entacapone added to levodopa-carbidopa), which payers sometimes prefer.

Indirect substitutes

• Extended-release levodopa-carbidopa regimens
• Other adjuncts used to reduce “off” time (pathway-dependent; selection depends on contraindications, side effects, and patient characteristics)

Competitive intensity tends to increase when

• the product is no longer a formulary preferred brand,
• at least one generic version launches,
• payers move from brand-preference to lowest-cost alternatives,
• multiple ANDA filers create a “race to settlement or launch” dynamic.

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What is the Orange Book status of STALEVO 75 and which patent types usually matter most?

Short answer: Orange Book status determines the barrier set that governs generic timing: composition-of-matter, formulation, and method-of-use or use-patents, plus possible exclusivities tied to NDA approvals and supplements.

Patent types that most affect launch economics

• Composition-of-matter patents that are broad and last longest.
• Formulation and stability patents if the brand claims specific manufacturing or stability-optimized compositions.
• Method-of-use patents that constrain labeling, if they are still listed and not carved out for infringement.
• Device/packaging patents usually matter less for generic tablets unless manufacturing or bioavailability is implicated.

Why strength matters

If a strength-specific formulation or manufacturing method is covered, generic entry can be segmented. If not, launch can expand across strengths quickly.

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How do ANDA Paragraph IV challenges affect STALEVO 75 market share and pricing?

Short answer: Paragraph IV challenges accelerate generic timing if litigation settles in a way that permits early or at-the-expense-of-remaining exclusivity launches. Market share dilution typically starts at first actual generic shipment, not at filing.

What settlement structures do to revenue

• “180-day exclusivity” dynamics for the first-to-file generic can determine whether the brand experiences a steep cliff or a phased erosion.
• Design-around settlements may delay effective competition even after dismissal of some patents, depending on launch carve-outs.
• “Copycat” designs can permit multiple generics to enter around the same time, driving faster price compression.

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What financial trajectory should investors and brand owners expect for STALEVO 75 after generic entry begins?

Short answer: The post-entry curve is usually steep for late-life brands: rapid net price compression within 6 to 18 months, continued share erosion, and then stabilization at a low branded premium if any patient segment resists switching.

Revenue path drivers

1. Net price erosion
   • List price may remain high, but rebates drive gross-to-net down quickly once generics win payer contracts.
2. Mix shift
   • Remaining branded demand often shifts to patients with prior tolerance to brand or where dosing convenience keeps prescribers from switching.
3. Contracting cycle speed
   • Payer contract renewal timing can accelerate or delay brand share loss.

Typical directionality (not point estimates)

• Before ANDA launch: gradual decline if growth is absent.
• Around first generic: steeper decline as payers change preferred status and pharmacies dispense lowest-cost options.
• After second/third generic: further compression until branded product becomes a residual niche.

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Which markets show the highest risk of faster STALEVO 75 decline: US, Germany, UK, France, or Italy?

Short answer: Jurisdictions with faster generic adoption and more aggressive payer tendering after patent expiry are at higher risk of quicker erosion.

Cross-market dynamics

• US: governed by Orange Book and litigation outcomes, then rebate-driven payer contracting.
• Germany/UK: tends to see faster formulary repricing after generics achieve tender or reimbursement preference.
• France/Italy: reimbursement and tender structures can produce pronounced discounting post-patent, but timing depends on national processes and uptake patterns.

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How does STALEVO 75 compare with competing COMT inhibitor strategies in market attractiveness?

Short answer: STALEVO 75 competes on dosing convenience and adherence while COMT inhibitor strategies compete on incremental efficacy and affordability, especially when generic component strategies are available.

Key comparison points

• Adherence and dosing consolidation
  • Fixed-dose combination can reduce pill burden relative to separate entacapone plus levodopa-carbidopa.
• Economic position
  • When generic entacapone or generic combination becomes preferred, the brand’s value is pressured.
• Clinical switching threshold
  • Patients and clinicians can switch across equivalents once stability and tolerability are established.

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What manufacturing and IP barriers could slow generic entry for STALEVO 75?

Short answer: Barriers are typically legal (patents) rather than technical for standard oral tablets, but manufacturing and bioequivalence can still affect launch pacing.

Potential sources of delay

• patent-specific manufacturing claims
• bioequivalence evidence if formulation changes affect release profile
• regulatory review timelines and CMC readiness

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Key commercial levers for brand survival: contracting, labeling, and patient adherence

Short answer: The remaining branded premium after generic entry depends on payer contracting, copay dynamics, and prescribing inertia tied to dose stability.

Contracting levers

• converting from formulary exclusion to preferred-but-discounted status can preserve volume at a lower net price
• maintaining a differential position through contracting strategies tied to total cost of care

Labeling levers

• method-of-use or patient-subset claims (where still relevant) can slow switching if payers allow continued brand use under specific criteria

Adherence levers

• tablet strengths and dosing flexibility influence prescriber willingness to switch from brand tablets to generic equivalents

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Key Takeaways

• STALEVO 75 market dynamics are dominated by late-life Parkinson’s prescribing stability and the speed of generic penetration once Orange Book and exclusivity barriers clear.
• Financial trajectory should follow a “gradual decline then step-down” pattern: modest erosion while exclusivity holds, then sharp net price compression after first generic launches, with further declines after additional competitors and payer preference shifts.
• Strength-level entry can accelerate across the range if dose interchangeability allows rapid substitution.
• The most material determinants of value are litigation outcomes, settlement terms affecting launch timing, and the speed of payer contracting and pharmacy dispensing behavior post-launch.

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FAQs

1. How quickly do payers switch from STALEVO 75 to generics after ANDA launches?
   Typically within the next contracting and formulary update cycle, with pharmacy dispensing switching immediately if the generic becomes the lowest-cost option under plan design.

2. Do STALEVO 75 strength-specific generics reduce branded sales across other STALEVO strengths?
   Often yes, because clinicians can titrate across available tablets and payers may prefer the lowest-cost equivalent per levodopa dosing.

3. What patent types usually delay generic competition for fixed-dose carbidopa/levodopa/entacapone tablets?
   Composition-of-matter and certain formulation/manufacturing or stability patents listed in the Orange Book can delay if they remain enforceable and not designed around.

4. How do 180-day exclusivity “first-to-file” dynamics affect STALEVO 75 revenue after generic entry starts?
   It can create a temporary competitive imbalance that slows or accelerates price erosion depending on whether the first entrant gains broad preferred status.

5. What non-price factors help retain branded STALEVO 75 volume during generics competition?
   Dosing convenience, tablet strength availability, and patient/physician switching inertia, supported by contracting that keeps branded options accessible with manageable patient cost-sharing.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Approval Packages: STALEVO (carbidopa/levodopa/entacapone). FDA.
3. U.S. Patent and Trademark Office. Patent Examination Research Data System and Patent Assignment Records. USPTO.
4. FDA. Sections 505(b)(2), 505(j), and exclusivity provisions relevant to ANDA approvals and patent certifications (regulatory background). FDA.