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:	81
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/002790 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.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/005782 Ontilyv 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
European Patent Office	2124947	SCHÉMA POSOLOGIQUE POUR DES INHIBITEURS DE LA CATÉCHOL-O-MÉTHYLTRANSFÉRASE (DOSAGE REGIMEN FOR COMT INHIBITORS)
European Patent Office	2413912	PRÉPARATIONS PHARMACEUTIQUES COMPRENANT DES DÉRIVÉS DE NITROCATÉCHOL ET LEURS PROCÉDÉS DE FABRICATION (PHARMACEUTICAL FORMULATIONS COMPRISING NITROCATECHOL DERIVATIVES AND METHODS OF MAKING THEREOF)
Hong Kong	1120266	NITROCATECHOL DERIVATIVES AS COMT INHIBITORS
Slovenia	2672973

Supplementary Protection Certificates for ONGENTYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	2016/054	Ireland		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1066 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	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

Market Dynamics and Financial Trajectory for ONGENTYS

Introduction to ONGENTYS

ONGENTYS, also known as opicapone, is a catechol-O-methyltransferase (COMT) inhibitor used in the treatment of Parkinson's disease. It is designed to enhance the effects of levodopa, a common medication for Parkinson’s, by preventing the breakdown of levodopa in the body.

Market Overview

The market for Parkinson's disease treatments is evolving, driven by extensive research, incremental healthcare spending, and the development of novel therapies. Here are some key points regarding the market dynamics for ONGENTYS:

Growing Market Size

The market for ONGENTYS is expected to grow significantly over the coming years. GlobalData forecasts that ONGENTYS will experience growth, reaching sales of $118.7 million across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan) by 2029, with a compound annual growth rate (CAGR) of 22.9%[4].

Competitive Landscape

The Parkinson's disease treatment market is highly competitive, with several emerging therapies expected to challenge ONGENTYS. Late-stage emerging therapies will significantly impact the market, and companies are developing novel approaches to treat and improve the disease condition[1].

Regional Market Performance

ONGENTYS is expected to perform differently across various regions. For instance, in Spain, ONGENTYS is forecasted to have sales of $3.8 million by 2029, growing at a CAGR of 2.3%[4]. Similar detailed forecasts are available for other major markets, including the US, Germany, France, Italy, the UK, and Japan[1].

Mechanism of Action and Clinical Efficacy

Mechanism of Action

ONGENTYS works by inhibiting the COMT enzyme, which is responsible for the breakdown of levodopa. This inhibition allows more levodopa to reach the brain, enhancing its therapeutic effects and reducing the need for frequent dosing[1].

Clinical Efficacy

Clinical trials and real-world data have shown that ONGENTYS is efficacious in managing Parkinson's disease. Key opinion leaders (KOLs) have noted that opicapone is often used as their first choice COMT inhibitor due to its efficacy and patient outcomes[4].

Regulatory and Developmental Milestones

Regulatory Approvals

ONGENTYS has received regulatory approvals in several countries, including the US and EU, marking significant milestones in its development. These approvals are crucial for its market penetration and acceptance by healthcare providers[1].

Developmental Activities

The development of ONGENTYS involves ongoing research and clinical trials to further establish its safety and efficacy. Companies are also focusing on assessing challenges and seeking opportunities that could influence ONGENTYS's dominance in the market[1].

Financial Performance and Projections

Sales Forecasts

As mentioned earlier, ONGENTYS is projected to achieve significant sales growth. The detailed market size forecasts from 2019 to 2032 provide a comprehensive view of its financial trajectory. For example, the market size in the seven major markets (7MM) is expected to grow substantially over this period[1].

Revenue Impact

The growth of ONGENTYS will contribute to the overall revenue of its manufacturers. For instance, if we consider the broader context of pharmaceutical companies like Neurocrine Biosciences, which reports significant revenue growth from their product sales, the success of ONGENTYS can be a key driver of such growth[5].

Challenges and Opportunities

Market Competition

ONGENTYS faces competition from other emerging therapies for Parkinson's disease. The launch of late-stage emerging therapies will significantly impact the market, and companies must adapt to these changes to maintain market share[1].

Healthcare Spending

Incremental healthcare spending across the world is expected to expand the market size for Parkinson's disease treatments. This trend presents opportunities for ONGENTYS to penetrate deeper into the market[1].

Real-World Clinical Practice

Efficacy in Real-World Settings

Studies and real-world clinical practice data have demonstrated the efficacy of ONGENTYS. Key opinion leaders have found opicapone to be highly effective, often using it as their first choice COMT inhibitor[4].

Patient Outcomes

The real-world efficacy of ONGENTYS translates into better patient outcomes. By enhancing the effects of levodopa, ONGENTYS helps in managing the symptoms of Parkinson's disease more effectively, improving the quality of life for patients.

Future Market Assessments

SWOT Analysis

A detailed SWOT analysis of ONGENTYS highlights its strengths, such as its efficacy and regulatory approvals, as well as its weaknesses, including market competition. The analysis also identifies opportunities, such as increasing healthcare spending, and threats, such as the launch of new therapies[1].

Analyst Views

Analysts' views on ONGENTYS are generally positive, given its clinical efficacy and market growth potential. However, they also highlight the need for continuous innovation and adaptation to market dynamics[1].

Conclusion

ONGENTYS is poised for significant growth in the Parkinson's disease treatment market. With its proven efficacy, regulatory approvals, and positive market forecasts, it is a key player in the therapeutic landscape. However, the market is competitive, and ongoing research and development are crucial for maintaining its market position.

Key Takeaways

• Market Growth: ONGENTYS is expected to achieve substantial sales growth, reaching $118.7 million across seven major markets by 2029.
• Clinical Efficacy: ONGENTYS has demonstrated efficacy in both clinical trials and real-world settings.
• Regulatory Milestones: ONGENTYS has received regulatory approvals in several countries.
• Market Competition: The market is highly competitive, with emerging therapies posing a challenge.
• Financial Projections: Detailed market size forecasts indicate a strong financial trajectory for ONGENTYS.

FAQs

Q: What is ONGENTYS used for?

A: ONGENTYS, or opicapone, is used in the treatment of Parkinson's disease to enhance the effects of levodopa by inhibiting the COMT enzyme.

Q: What are the market forecasts for ONGENTYS?

A: ONGENTYS is forecasted to reach sales of $118.7 million across the seven major markets by 2029, with a CAGR of 22.9%[4].

Q: How does ONGENTYS work?

A: ONGENTYS works by inhibiting the COMT enzyme, which breaks down levodopa, allowing more levodopa to reach the brain and enhance its therapeutic effects[1].

Q: What are the key challenges for ONGENTYS in the market?

A: ONGENTYS faces competition from other emerging therapies for Parkinson's disease and must adapt to changing market dynamics to maintain its market share[1].

Q: What is the regulatory status of ONGENTYS?

A: ONGENTYS has received regulatory approvals in several countries, including the US and EU, which is crucial for its market penetration and acceptance[1].

Sources

1. ONGENTYS Market Size, Forecast, and Market Insight - 2032 - ResearchAndMarkets
2. Neurocrine Biosciences Reports First Quarter 2023 Financial Results - Neurocrine Biosciences
3. Financial Results - Ono Pharmaceutical Co., Ltd.
4. EAN 2024: Opicapone demonstrates efficacy in real-world clinical practice - Clinical Trials Arena
5. Neurocrine Biosciences Reports First Quarter 2023 Financial Results - PR Newswire