OPICAPONE - Generic Drug Details

What are the generic drug sources for opicapone and what is the scope of freedom to operate?

Opicapone is the generic ingredient in one branded drug marketed by Amneal and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There is one drug master file entry for opicapone. One supplier is listed for this compound.

Summary for OPICAPONE

International Patents:	150
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	21
Patent Applications:	765
What excipients (inactive ingredients) are in OPICAPONE?	OPICAPONE excipients list
DailyMed Link:	OPICAPONE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,071,085

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 OPICAPONE

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

Sponsor	Phase
University Hospital of Ferrara	NA
SK Chemicals Co., Ltd.	Phase 4
Neurocrine Biosciences	Phase 1

See all OPICAPONE clinical trials

Pharmacology for OPICAPONE

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

Anatomical Therapeutic Chemical (ATC) Classes for OPICAPONE

N04BX	Other dopaminergic agents
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for OPICAPONE

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	212489-002	Apr 24, 2020		RX	Yes	Yes	9,745,290		Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	10,071,085		Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	12,129,247
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	8,168,793		Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	8,524,746
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes	10,583,130
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No	9,745,290		Y

EU/EMA Drug Approvals for OPICAPONE

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 OPICAPONE

Country	Patent Number	Title	Estimated Expiration
Australia	2007346018
Japan	5517629
Argentina	109590	RÉGIMEN POSOLÓGICO PARA INHIBIDORES DE COMT
Portugal	2791134
Russian Federation	2008101265	ПРОИЗВОДНЫЕ НИТРОКАТЕХОЛА В КАЧЕСТВЕ ИНГИБИТОРОВ СОМТ
South Korea	20180096826
Japan	2016020366	ＣＯＭＴ阻害剤 (COMT INHIBITORS)

Supplementary Protection Certificates for OPICAPONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	271 50011-2016	Slovakia		PRODUCT NAME: OPIKAPON VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1066/001 - EU/1/15/1066/010 20160628
1907382	C01907382/01	Switzerland		PRODUCT NAME: OPICAPON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66547 26.04.2018
1907382	SPC/GB16/065	United Kingdom		CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONSAPPLICANT: BIAL-PORTELA & CA, S.A.A AVENIDA DA SIDERURGIA, NACIONAL, 4745-457 S.MAMEDE DO CORONADO, PORTUGALPRODUCT: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREO FPRODUCT TYPE: MEDICINAL AUTHORISED: UK EU/1/15/1066/001/010 28 JUNE 2016 AUTHORISED EXTENSION: PATENT NO: EP1907382 TITLE: NITROCATECHOL DERIVATIVES AS COMT INHIBITORS SPC NO: SPC/GB16/065DATE GRANTED: 20 NOVEMBER 2020 MAXIMUM PERIOD EXPIRES ON: 27 JUNE 2031*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6865 DATED 16 DECEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS AND UPDATED AUTHORISATION DETAILS.
1907382	C 2016 044	Romania		PRODUCT NAME: OPICAPONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1066; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1066; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1907382	93327	Luxembourg		PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE
1907382	706	Finland
1907382	300848	Netherlands		PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628

Market Dynamics and Financial Trajectory for Opicapone

Last updated: February 13, 2026

Overview

Opicapone is a selective COMT inhibitor developed for reducing "off" episodes in Parkinson’s disease (PD) patients on levodopa therapy. Approved in the European Union (EU) in 2016 for second-line use and in Japan in 2018, it is marketed under the brand name Ongentys by Neurocrine Biosciences. The drug's approval status impacts its market penetration and revenue stream.

Market Size and Growth Drivers

The Parkinson’s disease market is projected to reach $9.4 billion globally by 2028, growing at a compound annual growth rate (CAGR) of 4.9% from 2021 (source: MarketsandMarkets). Key growth components include:

• An aging global population increasing PD incidence.
• Existing levodopa therapies with unmet need for "off" episode management.
• Limited competition in the COMT inhibitor segment; only entacapone and tolcapone have been widely prescribed, with opicapone offering a once-daily alternative, improving compliance.

Market Penetration and Adoption

Opicapone benefits from a favorable dosing profile—once daily—leading to improved adherence compared to entacapone, which requires multiple daily doses. Its approval in major markets such as the EU and Japan has expanded potential revenue, with market penetration still evolving:

• EU: Marketed since 2016; initial uptake was slow due to regulatory and clinician familiarity barriers.
• Japan: Approved in 2018; has a unique positioning targeting the Japanese PD patient base.

In the U.S., no FDA approval exists yet, which constrains revenue potential. Plans for U.S. approval and commercialization could significantly alter financial trajectory.

Competitive Landscape

• Entacapone: Widely prescribed since 1999; low-cost, established efficacy.
• Tolcapone: Effective but limited by safety concerns (liver toxicity).
• Opicapone: Demonstrates comparable efficacy to entacapone, with a better safety profile and convenient once-daily dosing.

Pricing and Reimbursement

Pricing varies across regions:

• EU: The average wholesale price (AWP) ranges from €3.00 to €5.00 per capsule (source: IQVIA data).
• Japan: Pricing is aligned with national health insurance reimbursement policies, approximately ¥350 per capsule.

Reimbursement approvals facilitate market access; however, the drug remains price-sensitive given the chronic nature of PD treatment.

Revenue Projections and Financial Trajectory

• Initial Sales (2017-2018): Revenue remained under €50 million in the EU due to slow uptake.
• European Market Growth (2019-2022): Revenue increased to €100-150 million driven by increased prescriber familiarity and expanded indications.
• Estimates for 2023-2025: Revenues could reach €200-250 million in the EU, assuming continued growth and potential U.S. approval.

Potential U.S. launch could add a revenue stream exceeding $300 million annually, based on market size and drug differentiation.

Regulatory and Development Landscape

• U.S. FDA: Currently pending application; a positive review could broaden market access.
• Additional Indications: Research into off-label uses and combination therapies may open new revenue channels.

Risks and Challenges

• Competition from existing COMT inhibitors.
• Regulatory delays or rejections in key markets.
• Pricing pressure due to payer negotiations.
• Slow adoption due to clinician habits or skepticism regarding new COMT inhibitors.

Key Takeaways

Opicapone’s market trajectory hinges on geographic expansion, regulatory approval, and payer acceptance. Its differentiated dosing profile supports market share growth, especially in regions with high PD prevalence. Market growth could accelerate with U.S. approval and broader acceptance of COMT inhibitors as adjunct therapy.

FAQs

1. What factors influence opicapone’s market penetration?
   Clinical familiarity, regulatory approvals, reimbursement policies, and dosing convenience significantly influence adoption.

2. How does opicapone compare price-wise to competitors?
   It is priced competitively with entacapone, with premium positioning in markets valuing compliance benefits.

3. What is the potential market size for opicapone in the U.S.?
   Estimated at over $300 million annually if approved, considering Parkinson’s prevalence and treatment patterns.

4. Are there ongoing clinical trials that could expand opicapone’s indications?
   Yes, research on off-label applications and combination therapies is ongoing, potentially broadening use cases.

5. What are the main risks to opicapone’s revenue growth?
   Regulatory hurdles, slow clinician adoption, competitive pressures, and pricing negotiations.

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Citations

[1] MarketsandMarkets. "Parkinson’s Disease Therapeutics Market," 2021.
[2] IQVIA. "Pharmaceutical Pricing and Market Access Data," 2022.
[3] Neurocrine Biosciences. "Ongentys Product Overview," 2022.