ONGENTYS Drug Patent Profile

Which patents cover Ongentys, and what generic alternatives are available?

Ongentys is a drug marketed by Amneal and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and fifty patent family members in thirty-one countries.

The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the opicapone profile page.

DrugPatentWatch^® Generic Entry Outlook for Ongentys

Ongentys was eligible for patent challenges on April 24, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 31, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ONGENTYS

International Patents:	150
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	335
Drug Prices:	Drug price information for ONGENTYS
What excipients (inactive ingredients) are in ONGENTYS?	ONGENTYS excipients list
DailyMed Link:	ONGENTYS at DailyMed

See drug prices for ONGENTYS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ONGENTYS

NDA:

212489

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ONGENTYS

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

Sponsor	Phase
Bial - Portela C S.A.	Phase 1
Bial - Portela C S.A.	Phase 4

See all ONGENTYS clinical trials

Pharmacology for ONGENTYS

Drug Class	Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

US Patents and Regulatory Information for ONGENTYS

ONGENTYS is protected by eleven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes

Expired US Patents for ONGENTYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020

EU/EMA Drug Approvals for ONGENTYS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bial - Portela Cª, S.A.	Ongentys	opicapone	EMEA/H/C/002790Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2016-06-24
Bial Portela & Companhia S.A.	Ontilyv	opicapone	EMEA/H/C/005782Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2022-02-21

International Patents for ONGENTYS

When does loss-of-exclusivity occur for ONGENTYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Japan

Mexico

Poland

Portugal

Russian Federation

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ONGENTYS around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010231961
Brazil	PI1014865
Canada	2757411
China	102448444
China	105878242

Supplementary Protection Certificates for ONGENTYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	300848	Netherlands		PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628
1907382	122016000095	Germany		PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	PA2016036	Lithuania		PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	CA 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382	93327	Luxembourg		PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE

ONGENTYS (opicapone) Market Dynamics and Financial Trajectory (Exclusivity, Competitors, Pricing, and Revenue Runway)

Last updated: July 22, 2026

ONGENTYS (opicapone) is a late-line COMT inhibitor for Parkinson’s disease “off” episodes, marketed mainly in the EU and a subset of geographies with established reimbursement. Financial trajectory hinges on (i) neurologist and payer uptake after initial launches, (ii) tolerance and persistence versus levodopa adjuncts, and (iii) the timing of exclusivity and patent cliffs for the branded product across jurisdictions.

Key commercial drivers are durable utilization in advanced PD patients with wearing-off treated on top of levodopa/carbidopa, and competitive substitution against other COMT inhibitors (entacapone, and to a lesser extent tolcapone) as well as newer device and pipeline approaches. Upside is tied to formulary access, starting-dose protocols, and retention. Downside is driven by payer pressure, generic erosion of older COMT competitors, and switching to cheaper regimens when cost-effectiveness thresholds tighten.

What is the market size and revenue ramp for ONGENTYS (opicapone) in Parkinson’s disease?

ONGENTYS targets Parkinson’s disease patients with motor fluctuations and “off” time while on levodopa. Commercial performance is therefore linked to the addressable population with wearing-off and the portion of those patients who are eligible for, and willing to stay on, COMT inhibitor add-on therapy.

Market demand drivers by payer and prescriber behavior

• Neurology prescribing: COMT inhibitors are commonly used after levodopa optimization, with entacapone historically the default in many markets due to established availability and pricing.
• Reimbursement gatekeeping: Access is typically controlled by payer criteria that specify “motor fluctuations/wearing-off” and adherence to levodopa dosing schedules.
• Persistence: Once-daily or constrained dosing (ONGENTYS is dosed once daily) tends to support continuation when compared with more frequent oral adjuncts, but tolerability and dyskinesia risk shape persistence.

Revenue ramp pattern that usually fits this category

• Launch years: Revenue depends on formulary wins and neurologist education.
• Mid-term: Growth stabilizes once target patient volumes saturate and payer restrictions harden.
• Later period: Branded revenue becomes sensitive to competitor price moves, generic share, and patent-driven competitive entry dynamics.

Which companies control ONGENTYS financial performance and what is the ownership/licensing structure?

The brand is commercialized under the market authorization and product management structure of its marketing authorization holder and regional distributors. Revenue performance reflects regional commercialization decisions: direct sales versus specialty distribution, and the intensity of payer contracting.

Key commercialization levers by region

• EU commercialization: Centralized MA support is paired with country-level reimbursement strategy.
• Specialty channels: Neurology-focused accounts and hospital formularies affect uptake in advanced PD segments.
• Contracting: Managed care and national health systems tend to shift toward cost-effectiveness comparisons among COMT inhibitors.

How do competitors and substitution dynamics affect ONGENTYS market share?

ONGENTYS sits in a competitive set of levodopa adjuncts and “off-time” targeting therapies. The most direct substitutes are COMT inhibitors, with device and other oral adjunct classes indirectly competing for budget and patient choice.

Direct competition: entacapone and tolcapone

• Entacapone: Widely used historically; generic availability in many markets creates price pressure on branded alternatives.
• Tolcapone: Less frequently used due to safety monitoring requirements; when used, it can reduce off time similarly, but adoption depends on local protocols.

Indirect competition: other “wearing-off” strategies

• Levodopa optimization: Dose frequency and formulation changes can reduce off time without switching add-on medication.
• Other adjuncts: Therapies used to reduce off periods can compete for patient and payer attention, especially if they have better total-treatment economics in specific subsegments.

What substitution means for financial trajectory

• Uptake risk: If payers direct patients to cheaper generic COMT options, ONGENTYS growth can be capped.
• Switching risk: Even after initial use, brand share can drift toward cheaper options when formularies change.
• Upside: If ONGENTYS offers superior adherence and durable off-time reduction outcomes, it can preserve share within payer criteria that allow premium COMT inhibitors.

When does ONGENTYS lose exclusivity and how does that timeline drive revenue?

ONGENTYS exclusivity is governed by a combination of patent term (composition, formulation, and method-of-use) and regulatory exclusivity protections tied to the first authorization and relevant supplements. Revenue decline risk rises as patent protection approaches key expiration windows in major markets.

Patent-driven revenue cliff mechanics for branded PD products

• Generic entry typically requires Paragraph IV for FDA products or equivalent legal mechanisms in other regions.
• Even without direct generic entry, loss of exclusivity can trigger:
  • payer reference pricing,
  • forced therapeutic interchange,
  • and increased discounting to maintain net price.

Exclusivity timeline impact points (high-level)

• Early exclusivity: supports higher gross-to-net pricing before competitor discounts accumulate.
• Mid-period: growth steadies while the brand defends through contracting and indication positioning.
• Late period: revenue performance becomes increasingly sensitive to patent expiration dates by jurisdiction.

What is the Orange Book status of ONGENTYS and where are ANDA risks highest?

For an FDA-status view to be actionable, it must be tied to a specific Orange Book listing: reference product, dosage form, active ingredient, and listed patents (including expiration dates). Without a precise Orange Book listing snapshot, the ANDA/Paragraph IV risk map cannot be stated accurately.

How strong is the ONGENTYS patent estate and what patents protect formulations or methods of use?

Patent strength is typically evaluated along three axes for small-molecule CNS brands:

1. Core composition of matter coverage and jurisdiction breadth.
2. Formulation or crystalline form protections that can slow generic development even after composition coverage expires.
3. Method-of-use or dosing regimen claims tied to clinical use, which can complicate generic label carve-outs.

Patent estate components that usually control litigation leverage

• Composition claims: generally strongest if broad and remaining term is meaningful.
• Formulation claims: can create barriers even when composition claims weaken.
• Second-use/dosing claims: can delay label substitution or enforce product-specific restrictions.

Litigation and enforcement pattern relevant to market dynamics

• Market dynamics shift materially when courts stay, invalidate, or uphold key claims.
• If a settlement allows generic launch in exchange for non-infringement positions, net impact is usually a step-down in branded pricing and volume.

What generic or biosimilar entry risks exist for ONGENTYS?

ONGENTYS is a small molecule (opicapone), so biosimilar risk does not apply. Generic risk is the relevant threat and is governed by patent expiration and regulatory approval pathway.

Generic entry scenarios that affect revenue trajectory

• Authorized generic or settlement-enabled entry: typically compresses price and share quickly.
• Direct generic launch after loss of exclusivity: can cut net price and force contracting repricing.
• Delayed entry via patent wins: preserves branded economics longer and supports continued discounting discipline.

How do pricing and reimbursement dynamics influence ONGENTYS financial trajectory?

Brand revenue trajectory in Parkinson’s products tends to correlate with the net price after rebates and payer rebates, plus reimbursement stability.

EU and payer mechanisms shaping net price

• Reference pricing: COMT inhibitor class comparators can cap premium pricing.
• Hospital formulary listing: drives initial access and then re-evaluation cycles.
• Prior authorization and step edits: can reduce off-time eligible volume and slow growth.

Where price pressure usually shows up

• After generic entacapone expands: payers compare total cost and push preferred products.
• During budget reallocation: when neurologists face therapy quotas, uptake can shift toward lower-cost options.
• Following formulary renegotiation: net price can drop even without new competitor launches.

What does ONGENTYS commercial performance imply about persistence and patient outcomes?

Market share durability for a wearing-off adjunct is strongly tied to persistence. In practice, persistence for a COMT inhibitor depends on:

• Off-time reduction consistency in routine clinic settings
• Dyskinesia and adverse event profile relative to comparator COMT inhibitors
• Ease of use: once-daily dosing supports adherence
• Stable tolerability over months

Financially, persistence changes both:

• the denominator of active treated patients, and
• time-to-switch after payer edits.

ONGENTYS vs entacapone: how does cost and convenience alter market outcomes?

A practical way to view market dynamics is as a balance between:

• drug acquisition cost (net price),
• dosing convenience,
• and clinical impact on “off” time.

Typical payer framing for COMT inhibitor selection

• If generic entacapone is preferred by payers, ONGENTYS must justify premium net cost via adherence and outcomes.
• If neurologists see fewer adherence barriers and stable off-time reduction with ONGENTYS, brand switching becomes more durable even under price pressure.

Financial trajectory implication

• If ONGENTYS maintains formulary access and demonstrates durable persistence, revenue can remain resilient through mid-cycle.
• If formularies narrow to preferred generic entacapone, brand share typically erodes and revenue growth becomes flat to negative.

Key regulatory milestones that can change ONGENTYS growth

Regulatory milestones affecting commercialization include:

• label expansions (if any) tied to dosing or patient subgroups,
• changes in reimbursement status following new evidence,
• and regulatory actions affecting manufacturing continuity.

What to watch for commercially

• Pharmacovigilance actions that affect prescribing comfort
• Label revisions that expand or constrain eligible patient populations
• Local HTA reviews that can change reimbursement decisions

What is the investment and licensing outlook for ONGENTYS based on market dynamics?

Licensing and partnership valuation for a mature small molecule in neuro typically reflects:

• remaining patent duration,
• evidence of class differentiation (clinically meaningful off-time reduction plus tolerability),
• and probability of sustaining reimbursement.

In a COMT inhibitor class where generic availability for older agents exists in many markets, the licensability value increases when:

• patent estate coverage is robust through key launch jurisdictions,
• the brand has strong persistence and formulary retention,
• and the net price can be defended via payer contracting.

Key Takeaways

• ONGENTYS revenue trajectory is driven by persistence in advanced PD “wearing-off” patients plus payer/formulary retention.
• Market growth is constrained by substitution risk from generic entacapone and by payer cost-effectiveness frameworks across COMT inhibitors.
• The biggest revenue inflection is patent-exclusivity timing by jurisdiction, which determines when pricing discipline breaks and generic penetration accelerates.
• Financial durability depends more on net price and active-treated patient retention than on incremental uptake once early launch targets are met.

FAQs

1. How does generic entacapone penetration typically affect net pricing for branded COMT inhibitors like ONGENTYS?
2. What formulary criteria most often determine whether ONGENTYS stays preferred for Parkinson’s off-time therapy?
3. How do patent expirations for small-molecule PD adjuncts translate into accelerated demand loss even before generic launches?
4. Which dosing convenience attributes drive persistence for once-daily COMT inhibitor adjuncts in wearing-off patients?
5. What commercial metrics (TRx, persistence, net price) best predict ONGENTYS revenue trajectory in managed-care environments?

References

1. (No citable source list was produced because the request does not include an ONGENTYS Orange Book listing snapshot, patent numbers/expiration dates, or jurisdictional authorization/regulatory status needed to produce a complete, accurate financial and exclusivity analysis.)

DrugChatter Q&A for ONGENTYS

How does Ongentys work for Parkinson's disease?