STALEVO 100 Drug Patent Profile

Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 100

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	17
Patent Applications:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STALEVO 100
DailyMed Link:	STALEVO 100 at DailyMed

Recent Clinical Trials for STALEVO 100

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Asan Medical Center	N/A
IRCCS San Raffaele	Phase 2

See all STALEVO 100 clinical trials

Pharmacology for STALEVO 100

Drug Class	Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

US Patents and Regulatory Information for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003

EU/EMA Drug Approvals for STALEVO 100

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Levodopa/Carbidopa/Entacapone Orion	levodopa, carbidopa, entacapone	EMEA/H/C/002441 Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2011-08-23
Orion Corporation	Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	levodopa, carbidopa, entacapone	EMEA/H/C/002785 Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.	Authorised	no	no	no	2013-11-11
Orion Corporation	Stalevo	levodopa, carbidopa, entacapone	EMEA/H/C/000511 Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2003-10-17

International Patents for STALEVO 100

See the table below for patents covering STALEVO 100 around the world.

Country	Patent Number	Title	Estimated Expiration
Estonia	05473	Levodopa/karbidopa/entakapooni farmatseutiline preparaat, selle valmistamise meetod ja kasutamine
Canada	2378469	COMPOSITION ORALE SOLIDE COMPRENANT DE LA CARBIDOPA, DE LA LEVODOPA ET DE L'ENTACAPONE (AN ORAL SOLID COMPOSITION COMPRISING CARBIDOPA, LEVODOPA ANDENTACAPONE)
Japan	4885896
Czechoslovakia	277018	PROCESS FOR PREPARING NOVEL PHARMACOLOGICALLY ACTIVE DERIVATIVES OF CATECHOL
Finland	109453

Supplementary Protection Certificates for STALEVO 100

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0426468	91071	Luxembourg		91071, EXPIRES: 20151101
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	CA 2004 00007	Denmark

STALEVO 100 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Stalevo 100

Introduction

Stalevo, a combination drug comprising carbidopa, levodopa, and entacapone, is a crucial treatment for patients with Parkinson’s disease, particularly those experiencing the end-of-dose "wearing off" phenomenon. Here, we delve into the market dynamics and financial trajectory of Stalevo 100, a specific dosage strength of this medication.

Market Overview of Parkinson’s Disease Treatments

The global Parkinson’s disease market is projected to grow significantly, with an estimated market value of $11.66 billion by 2030, up from $3.6 billion in 2023, reflecting a Compound Annual Growth Rate (CAGR) of 11.2%[3].

Role of Stalevo in Parkinson’s Disease Treatment

Stalevo is designed to enhance the antiparkinson effects of levodopa by combining it with the enzyme inhibitors carbidopa and entacapone. This combination helps maintain higher and more sustained levels of levodopa in the blood, thereby improving symptom control and reducing the "wearing off" effect[1][4].

Market Segmentation and Revenue

The Levodopa/Carbidopa segment, which includes Stalevo, accounts for the highest revenue-generating segment in the global Parkinson’s disease market. This is due to the widespread use of levodopa as the gold standard treatment for Parkinson’s disease[3].

Regional Market Performance

North America is expected to hold the highest revenue share during the forecast period, driven by advanced healthcare infrastructure, high prevalence of Parkinson’s disease, and strong research and development activities. The Asia Pacific region, however, is anticipated to grow at the fastest CAGR due to its large population base, increasing awareness of neurological disorders, and improving healthcare infrastructure[3].

Dosage Strengths and Flexibility

Stalevo is available in six different dosage strengths, including the 100/25/200 mg formulation. The approval of various dosage strengths, such as Stalevo 75 and 125 tablets, provides physicians with greater flexibility in treating patients, allowing for more customized treatment approaches[1][4].

Safety and Efficacy

While Stalevo significantly improves motor function and daily activities for patients with Parkinson’s disease, it can also lead to side effects such as severe uncontrolled movements (dyskinesias), mood swings, and other behavioral changes, especially at higher doses[4].

Financial Performance of Novartis

Novartis Pharmaceuticals Corporation, the marketer of Stalevo in the U.S., has seen varied financial performances in recent years. However, the overall pharmaceutical market trends suggest that innovative treatments like Stalevo contribute positively to the company's revenue. For instance, Novartis's focus on innovative therapies and its robust pipeline are key drivers of its financial growth[2].

Revenue Contribution of Stalevo

Although specific financial data for Stalevo 100 is not readily available, the drug's inclusion in the broader Levodopa/Carbidopa segment indicates its significant revenue contribution. The segment's high revenue is a testament to the demand and efficacy of Stalevo and similar treatments.

Competitive Landscape

The Parkinson’s disease treatment market is competitive, with several pharmaceutical companies investing in research and development. Collaborations, such as the one between Just - Evotec Biologics and Sandoz, highlight the industry's emphasis on innovation and expanding treatment options[3].

Future Outlook

The growing prevalence of Parkinson’s disease and the need for more effective and sustained treatments position Stalevo 100 for continued market relevance. As healthcare infrastructure improves globally, especially in the Asia Pacific region, the demand for advanced Parkinson’s disease treatments is expected to rise.

Regulatory Approvals and Compliance

Stalevo was originally approved by the U.S. FDA in June 2003 and has since been marketed in various dosage strengths. Regulatory approvals and compliance are crucial for the continued availability and success of Stalevo 100[1].

Patient Impact and Quality of Life

Stalevo 100 significantly improves the ability of patients to control body movements and perform daily activities, enhancing their overall quality of life. This is particularly important for patients experiencing the "wearing off" phenomenon, as it allows for more consistent symptom management[1].

Conclusion

Stalevo 100 is a vital component in the treatment of Parkinson’s disease, offering improved symptom control and greater dosing flexibility. The drug's market dynamics are influenced by the growing demand for effective Parkinson’s treatments, regional healthcare advancements, and the competitive landscape of the pharmaceutical industry.

Key Takeaways

• Market Growth: The global Parkinson’s disease market is projected to reach $11.66 billion by 2030.
• Dosage Flexibility: Stalevo is available in multiple dosage strengths, including 100/25/200 mg, providing treatment flexibility.
• Regional Performance: North America and the Asia Pacific region are key markets due to their healthcare infrastructure and growing demand.
• Safety and Efficacy: Stalevo improves symptom control but can have side effects at higher doses.
• Financial Contribution: Stalevo contributes significantly to the revenue of its marketers, such as Novartis.

FAQs

Q: What is Stalevo used for? A: Stalevo is used to treat Parkinson’s disease, particularly for patients experiencing the end-of-dose "wearing off" phenomenon.

Q: What are the components of Stalevo? A: Stalevo combines carbidopa, levodopa, and entacapone to enhance the antiparkinson effects of levodopa.

Q: What are the available dosage strengths of Stalevo? A: Stalevo is available in six different dosage strengths, including 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, 150/37.5/200 mg, and 200/50/200 mg.

Q: What are the potential side effects of Stalevo? A: Potential side effects include severe uncontrolled movements (dyskinesias), mood swings, and other behavioral changes, especially at higher doses.

Q: Who markets Stalevo in the U.S.? A: Stalevo is marketed in the U.S. by Novartis Pharmaceuticals Corporation.

Sources

1. BioSpace - Two New Dosage Strengths Of Stalevo(R) Approved In ...
2. AMGEN - AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS
3. GlobeNewswire - $11.66 Billion Parkinson's Disease Market Forecast, 2030 by Drug Class, Medical Devices, Devices Route of Administration, Distribution Channel, and Region
4. Medsafe - Stalevo® | Medsafe