COMTAN Drug Patent Profile

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

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

The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Comtan

A generic version of COMTAN was approved as entacapone by SUN PHARM on July 16^th, 2012.

Summary for COMTAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	7
Patent Applications:	7,403
Drug Prices:	Drug price information for COMTAN
What excipients (inactive ingredients) are in COMTAN?	COMTAN excipients list
DailyMed Link:	COMTAN at DailyMed

See drug prices for COMTAN

Recent Clinical Trials for COMTAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daniel Claassen	Phase 1
Xiangya Hospital of Central South University	Early Phase 1
National Institute of Biological Sciences, Beijing	Phase 1/Phase 2

See all COMTAN clinical trials

Paragraph IV (Patent) Challenges for COMTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMTAN	Tablets	entacapone	200 mg	020796	1	2007-04-11

US Patents and Regulatory Information for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	AB	RX	Yes	Yes

Expired US Patents for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	4,963,590
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,135,950
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	6,599,530
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,446,194
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,112,861

EU/EMA Drug Approvals for COMTAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Entacapone Orion	entacapone	EMEA/H/C/002440Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	2011-08-18
Orion Corporation	Comtess	entacapone	EMEA/H/C/000170Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-16
Orion Corporation	Comtan	entacapone	EMEA/H/C/000171Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-22
Teva Pharma B.V.	Entacapone Teva	entacapone	EMEA/H/C/002075Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	yes	no	no	2011-02-18

International Patents for COMTAN

See the table below for patents covering COMTAN 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 COMTAN

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

Last updated: June 24, 2026

COMTAN (entacapone) Market Dynamics and Financial Trajectory (Sales, Pricing, Competition, and IP Timing)

Executive summary: COMTAN (entacapone) is a mature, off-patent Parkinson’s disease adjunct. Its U.S. revenue profile has been shaped by (1) long-standing generic availability, (2) substitution from alternative dopamine-comtansation strategies, and (3) constrained brand economics typical of an older, niche product without meaningful new formulation or life-cycle differentiation. The brand’s financial trajectory tracks Parkinson’s disease incidence growth but is heavily discounted by generic penetration and payer substitution.

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Is COMTAN (entacapone) still a meaningful branded product in the US and EU?

COMTAN is marketed as an adjunct to levodopa/carbidopa for Parkinson’s disease, used to extend the effect of each levodopa dose. As a “late-life” specialty neurology brand, its market dynamics are dominated by payer cost controls and generic substitution rather than incremental clinical differentiation.

Core market structure

• Therapeutic category: Adjuncts to levodopa in Parkinson’s disease (dopamine metabolism inhibitors, catechol-O-methyltransferase/COMT inhibitors).
• Primary competitor class: Other COMT inhibitors (notably opicapone in more recent years).
• Economic driver: Generic entacapone substitution suppresses brand pricing power in the U.S. and Europe.
• Utilization pattern: Chronic, long-term therapy; demand is relatively stable, but brand share declines when low-cost alternatives exist.

Implication for financial trajectory

• Branded COMTAN sales trend typically declines as:
  1. generics capture share,
  2. payers prefer lower net cost,
  3. prescribers shift to newer options when clinically and logistically preferred.

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When did generic entacapone erode COMTAN’s market share and revenue?

COMTAN’s branded economics have been constrained by generic entry timelines that removed U.S. exclusivity value and by payer formularies that steer to lowest-cost equivalents.

Key revenue impact channels

1. Wholesale acquisition cost compression once generics scale.
2. Formulary movement from preferred brand to generic.
3. Patient share shift driven by pharmacy benefit manager (PBM) contracting.
4. Therapeutic switches when newer COMT inhibitors (especially opicapone) gain uptake.

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What are the main competitive pressures on COMTAN from other Parkinson’s therapies?

Competition comes from both direct pharmacologic substitutes and indirect payer management that rewards simpler dosing or lower net cost.

Direct substitute: opicapone (COMT inhibitor)

Opicapone entered as a newer-generation COMT inhibitor with convenient dosing (once daily dosing in labeling). That dosing convenience can increase payer and prescriber preference even when overall drug-class effectiveness is similar in real-world use.

Indirect pressure: levodopa optimization

In practice, many Parkinson’s regimens emphasize:

• levodopa dosing optimization,
• adjuncts such as MAO-B inhibitors, dopamine agonists, and device-aided strategies in later disease,
• switching patterns that reduce add-on reliance when costs or tolerability shift.

Net effect on COMTAN

• Brand share declines as prescriber behavior shifts toward regimens that improve adherence, reduce clinic burden, or reduce payer cost.
• Generic entacapone narrows the brand’s remaining differentiation to non-clinical factors, which are usually not enough to prevent share erosion.

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How do COMTAN price dynamics typically behave under generic penetration?

In markets with mature generics, branded pricing typically follows a negative trajectory driven by:

• reimbursement pressure,
• limits on brand net pricing,
• contracting terms that reduce effective reimbursement above generic acquisition cost.

What to expect in financial statements

For older neurology adjuncts, investor commentary and payer trends typically show:

• stable volume but declining brand net pricing,
• increasing substitution to generics even when total class demand remains stable,
• revenue volatility tied to inventory movements and contract resets.

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What is COMTAN’s FDA status and how does that affect market access?

COMTAN is an FDA-approved small-molecule drug for Parkinson’s disease adjunct therapy. Market access is then governed less by patent exclusivity and more by:

• generic availability,
• Orange Book listings and patent term structure,
• PBM formularies and state Medicaid preferred drug lists,
• therapeutic interchange policies.

Practical access dynamics

• Once generics are available, branded COMTAN competes on net price and contract terms.
• Coverage becomes contingent on pharmacy-level reimbursement rather than brand exclusivity.

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What is the patent and regulatory landscape for COMTAN, and when did it lose exclusivity?

COMTAN’s exclusivity has long since elapsed relative to its original launch era. As a result, the brand’s market has been driven primarily by generic competition rather than active exclusivity.

How exclusivity shape is reflected in revenue

• A mature brand with no meaningful active exclusivity will show:
  • minimal pricing resilience,
  • reduced ability to maintain premium margins,
  • low probability of sustained brand revenue growth absent a new product form factor.

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What patent estates protect COMTAN today: does COMTAN still have formulation or method-of-use value?

For older small molecules, any remaining value tends to be limited to:

• secondary patents (manufacturing processes, specific polymorphs, or method claims),
• patents with narrow scope that do not materially block generic entry.

Commercial implication

Even if patents exist, payer and pharmacy substitution plus the presence of therapeutically substitutable products often limits branded economics.

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How does COMTAN compare with opicapone and other COMT inhibitors on market outcome risk?

COMTAN is structurally exposed to “older-medicine” economics:

• generic substitution compresses brand revenue,
• prescribers may prefer newer dosing convenience or payer-favored alternatives.

Comparison snapshot

Feature	COMTAN (entacapone)	Opicapone (class comparator)
Patent-driven brand protection	Limited due to age and generic presence	Newer class member with more recent market position
Payer bias	Typically generic first	Often preferred depending on formulary and net price
Dosing convenience	Multiple daily integration with levodopa schedule	Convenient once-daily pattern (per labeling)
Market outcome risk	High brand erosion risk	Lower brand erosion risk early post-entry

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What are the most likely revenue drivers that can still move COMTAN financial performance?

Even with generic pressure, short-run financial swings can occur due to:

1. Inventory and channel fill adjustments ahead of contract changes.
2. Regional formulary resets where brand may remain “covered” but at lower priority.
3. Neuro-specialty prescribing patterns where specific switching behavior lags payer policy.
4. Seasonality in demand common to chronic neurology (usually modest).

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What generic entry risks exist for COMTAN products and how do they affect near-term financials?

Once generic entry is already in place, “entry risk” shifts from new generic launches to:

• additional ANDA approvals expanding supply,
• price competition among generics,
• reimbursement rate resets that may further lower brand effective revenue.

Near-term financial translation

• Brand net revenue tends to drift toward minimal “covered but not preferred” status.
• Gross margin remains pressured if brand pricing fails to reflect competitive net economics.

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Is COMTAN revenue exposed to biosimilar risk or is it purely small-molecule competition?

COMTAN is a small molecule; biosimilar frameworks do not apply.

Competition model

• The competitive risk is generics and other small molecules in class, not biosimilar substitution.

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What litigation and settlement dynamics typically matter for COMTAN’s market trajectory?

For legacy small molecules, if litigation occurred, its market effect generally shows up as:

• entry timing changes,
• settlement-driven delayed launches in certain jurisdictions,
• brand share effects after entry.

Practical market takeaway

Because COMTAN is already mature, the dominant current driver is not active litigation but ongoing formulary and generic economics.

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How does COMTAN perform commercially across key geographies (US, EU5, UK)?

Geographic performance is usually aligned with:

• generic adoption speed,
• strength of payer tender systems,
• national pricing and reimbursement frameworks.

Expected pattern

• US: strongest pressure from PBM contracting and generic availability.
• EU major markets: similar erosion where generics are entrenched; product continuity depends on national reimbursement and prescribing habits.
• UK: NHS reimbursement and generic substitution tends to constrain branded net economics.

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What does COMTAN’s financial trajectory imply for investors, licensors, or category entrants?

For investors and category strategists, the COMTAN case is a template for:

• low growth brand sustainability without life-cycle differentiation,
• reliance on stable chronic volume only,
• limited upside absent new clinical or delivery differentiation that creates formulary re-entry.

Licensing implications

• Acquiring rights for a mature generic-supplied molecule typically has low upside unless:
  • there is a path to exclusivity through a differentiated product,
  • a licensing arrangement captures manufacturing, distribution, or combination opportunities.

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Key Takeaways

• COMTAN is a mature entacapone brand with financial performance dominated by generic substitution and payer formulary contracting.
• Market dynamics are shaped more by cost management and substitution to other COMT inhibitors (notably opicapone) than by incremental clinical differentiation.
• The financial trajectory is structurally downward in branded value while chronic class demand may remain stable at the molecule level.
• Remaining upside hinges on contracting nuances and niche prescribing persistence, not on exclusivity expansion or broad patent-driven barriers.

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FAQs

1) Does COMTAN face substitution from generics in all major markets?
Yes, where generic entacapone is available and payer policy favors lowest net cost.

2) Can COMTAN regain formulary preference in a payer environment?
It can move between covered tiers based on net price and contracting, but sustained branded economics typically require a differentiated economic proposition because clinical-class substitutes exist.

3) Is switching from COMTAN to opicapone common?
Switching can occur when dosing convenience and formulary preference align, particularly for patients managed in structured neurology pathways.

4) Are there any new COMT inhibitors likely to further pressure entacapone demand?
The primary risk comes from continued uptake of newer-generation COMT inhibitors and treatment regimen optimization.

5) What business levers most influence COMTAN’s near-term revenue?
PBM/NHS contracting, channel inventory management, and relative net pricing versus generic entacapone and in-class alternatives.

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References (APA)

1. FDA. (n.d.). Drug Approval Reports and Product Label Information for entacapone (COMTAN). U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for entacapone. U.S. Food and Drug Administration.
3. Centers for Medicare & Medicaid Services (CMS). (n.d.). Part D Drug Pricing and Utilization Resources (background on reimbursement dynamics for generic vs brand). CMS.