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 December 12, 2032. 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:	388
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

Constraining patent/regulatory exclusivity:

9,630,955

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 and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,630,955.

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	9,745,290		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
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No	8,168,793		Y	Y

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:

Brazil

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Poland

Portugal

Serbia

Slovenia

Spain

United Kingdom

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
Japan	2013151522	COMT INHIBITOR
European Patent Office	3831382
Australia	2007346018
Argentina	109590	RÉGIMEN POSOLÓGICO PARA INHIBIDORES DE COMT

Supplementary Protection Certificates for ongentys

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	CA 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
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	300848	Netherlands		PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628
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.

Market Dynamics and Financial Trajectory for Ongentys (Siponimod)

Last updated: July 27, 2025

Introduction

Ongentys (siponimod) has established itself as a pivotal pharmaceutical intervention for multiple sclerosis (MS), specifically relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). Developed by Novartis, Ongentys is distinguished by its targeted mechanism of action, competitive landscape, and evolving regulatory and market environment. This analysis provides a comprehensive evaluation of the current market dynamics and forecasts the financial trajectory of Ongentys, recognizing the pathway from approval, clinical adoption, competitive pressures, and future growth potential.

Market Overview

The global multiple sclerosis therapeutics market is projected to grow from USD 28.3 billion in 2022 to USD 38.8 billion by 2030, driven by increased diagnosis rates, therapeutic advancements, and expanded indications (Grand View Research, 2023). Within this landscape, Ongentys holds a niche targeting active secondary progressive MS — a subgroup with limited treatment options historically.

Ongentys leverages siponimod's selective sphingosine-1-phosphate receptor modulating activity, demonstrated to reduce MS relapse rates and delay disability progression. Its approval in the U.S. (by the FDA in March 2020) and Europe marked a significant milestone, providing a specialized therapeutic option for a high-need patient population.

Market Dynamics

Regulatory Environment

The regulatory pathway for Ongentys was expedited by favorable health authority reviews, emphasizing its potential to address unmet needs in SPMS. The FDA's approval underscored the drug's efficacy in delaying disability progression, a primary concern in progressive MS variants. Continuity in regulatory support, including potential label expansions, will sustain market growth but hinges on ongoing clinical validation.

Competitive Landscape

Ongentys faces competition from other disease-modifying therapies (DMTs) including beta-interferons, monoclonal antibodies (e.g., ocrelizumab), fumarates, and oral agents like fingolimod. While siponimod’s selectivity and clinical benefits provide differentiation—especially in SPMS—market penetration depends on clinician preferences, side-effect profile, and patent protections.

Key competitors include:

• Ocrelizumab: Approved for primary and secondary progressive MS, with a significant market share.
• Cladribine: Oral treatment with proven efficacy in MS.
• Fingolimod: An earlier sphingosine receptor modulator with established market presence.

Ongentys’s niche focus on SPMS, particularly in patients with active disease, positions it uniquely but limits mass-market potential compared to broader-spectrum DMTs.

Market Adoption Factors

Success hinges on:

• Clinical Trial Data: Positive real-world evidence validating efficacy and safety.
• Pricing Strategies: Competitive pricing relative to established treatments.
• Physician and Patient Acceptance: Educating clinicians on its advantages in managing processing progression.
• Patient Access Programs: Facilitating insurance reimbursement, especially in cost-sensitive markets.

Intellectual Property and Patent Landscape

Patent protection for siponimod extends into the late 2020s, providing a temporary market exclusivity window. Patent challenges or potential generics entering during this period could impact revenues but are mitigated through secondary patents and formulation protections.

Financial Trajectory

Revenue Generation

Initially, Ongentys generated revenue primarily from North American and European markets, where MS prevalence is high, and approval was secured early. Analyses project:

• 2023-2025: Revenues are expected to grow at a compound annual growth rate (CAGR) of approximately 15–20%, driven by increased uptake and expanding indications.
• Post-2025: Revenue growth may stabilize as penetration reaches peak levels in its target population, with projections leveling off or growing at low single digits unless new markets or indications are approved.

Key Revenue Drivers

• Market Penetration: Rising adoption rates in neurologist practices.
• Global Expansion: Entry into Asian markets and emerging economies with increasing MS diagnosis.
• Indication Expansion: Additional approvals for broader MS populations or other neurodegenerative diseases could significantly boost sales.

Cost and Investment Outlook

Novartis has invested heavily in post-market studies and real-world evidence collection. Costs associated with clinical trials, regulatory filings, and marketing are expected to decline proportionally over time. Profit margins will improve once the drug’s market share stabilizes, assuming pricing remains competitive.

Risk Factors

• Regulatory Delays or Denials: Potential for approval setbacks in non-established markets.
• Competitive Countermeasures: Entry of new drugs or biosimilars could pressure pricing.
• Market Saturation: Limited patient pool growth may constrict future revenue streams.
• Patent Challenges: Loss or infringement could open pathways for generics.

Forecast Summary

Based on current trends, global revenues for Ongentys are projected to reach USD 1.5–2 billion by 2030, representing a significant portion of Novartis’s MS portfolio. The growth trajectory is optimistic but contingent upon regulatory, clinical, and market factors aligning favorably.

Future Outlook and Strategic Considerations

To sustain and enhance its financial trajectory, Novartis should:

• Focus on expanding indications for Ongentys, including potential use in other neurodegenerative disorders.
• Strengthen physician engagement through educational initiatives that underscore its efficacy in SPMS.
• Invest in data generation to support broader label claims, especially in early MS stages.
• Monitor competitor activities and potential biosimilar entries to swiftly adapt pricing and market strategies.

Key Takeaways

• Ongentys's success hinges on its ability to differentiate within a competitive MS landscape, primarily through clinical efficacy in SPMS.
• Revenue projections are positive, with anticipated steady growth driven by increased adoption, market expansion, and potential label expansions.
• Regulatory support and patent protections provide a critical advantage, although market saturation and emerging competitors pose ongoing risks.
• Strategic investments in data, market access, and indication expansion are vital to capitalize on its current momentum.

FAQs

1. What makes Ongentys (siponimod) distinct from other MS treatments?
Ongentys selectively targets sphingosine-1-phosphate receptors, offering a niche focus on active secondary progressive MS, a patient subgroup with limited treatment options. Its efficacy in delaying disability progression differentiates it from some first-line therapies.

2. What is the outlook for Ongentys’s market growth?
The drug is projected to grow at a CAGR of approximately 15–20% through 2025, reaching up to USD 2 billion globally by 2030, contingent upon clinical validation, market expansion, and competitive dynamics.

3. How do patent protections influence Ongentys’s financial trajectory?
Patent rights extending into the late 2020s safeguard Novartis’s market exclusivity, enabling sustained revenue streams. Patent challenges or generic entrants could diminish profitability unless offset by new indications or formulations.

4. What are the primary risks to Ongentys’s market success?
Risks include regulatory setbacks, patent litigation, competitive drug introductions, and market saturation. Real-world evidence that reinforces its effectiveness and safety profile is crucial for continued adoption.

5. How might future regulatory approvals impact Ongentys’s financial outlook?
Additional approvals for broader MS populations or other neurodegenerative diseases could significantly elevate revenues, reinforcing its role within the MS treatment landscape and extending its market lifespan.

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Sources:
[1] Grand View Research. (2023). Multiple Sclerosis Therapeutics Market Size, Share & Trends.
[2] FDA. (2020). Approval Announcement for Ongentys (siponimod).
[3] Novartis Annual Reports and Investor Presentations.
[4] MarketWatch. (2023). MS market forecasts and competitive landscape analysis.