STALEVO 150 Drug Patent Profile

When do Stalevo 150 patents expire, and what generic alternatives are available?

Stalevo 150 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 150 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 150

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	17
Patent Applications:	5
DailyMed Link:	STALEVO 150 at DailyMed

Recent Clinical Trials for STALEVO 150

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 150 clinical trials

Pharmacology for STALEVO 150

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

US Patents and Regulatory Information for STALEVO 150

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 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	6,500,867
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	4,963,590
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	6,797,732
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	5,446,194
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	5,135,950

EU/EMA Drug Approvals for STALEVO 150

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 150

See the table below for patents covering STALEVO 150 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 150

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 150 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STALEVO 150

Introduction

STALEVO 150, a combination drug containing carbidopa, levodopa, and entacapone, is a crucial treatment for patients with idiopathic Parkinson's disease. This article delves into the market dynamics and financial trajectory of STALEVO 150, highlighting its significance, market performance, and future outlook.

Indication and Usage

STALEVO 150 is indicated for the treatment of Parkinson's disease, specifically designed to substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual products. It is available in various strengths, with the 150 mg formulation containing 37.5 mg of carbidopa, 150 mg of levodopa, and 200 mg of entacapone[4].

Market Size and Growth

The global Parkinson's disease market is projected to reach $11.66 billion by 2030, with the Levodopa/Carbidopa segment, which includes STALEVO, accounting for the highest revenue-grossing segment. This growth is driven by factors such as advanced healthcare infrastructure, high prevalence of Parkinson's disease, and strong research and development activities, particularly in North America and the Asia Pacific region[3].

Sales Performance

Historically, STALEVO has demonstrated strong sales performance. For the 12 months ending March 31, 2013, STALEVO had U.S. sales of approximately $138.6 million. This figure underscores the drug's market presence and demand within the Parkinson's disease treatment landscape[1].

Regional Market Dynamics

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

Competitive Landscape

The market for Parkinson's disease treatments is competitive, with several pharmaceutical companies involved in research and development. Mylan's settlement and license agreement with Orion Corporation allowed Mylan to launch an authorized generic version of STALEVO, which has impacted the competitive dynamics. This move has opened up the market to more affordable generic options, potentially altering the financial trajectory of the branded version[1].

Financial Trajectory

The financial performance of STALEVO is closely tied to the overall performance of its parent company, Orion Corporation. In the first quarter of 2009, Orion reported that STALEVO's net sales were up by 22.1%, accounting for 24% of the total net sales generated by the Pharmaceuticals business. However, operating profit was lower due to higher investments in product development[2].

Revenue Contribution

STALEVO has been a significant contributor to Orion's revenue. The drug's strong sales have helped maintain a robust financial position for the company, despite fluctuations in operating profit due to R&D investments and other operational expenses[2].

Generic Competition

The introduction of generic versions, such as Mylan's authorized generic, has the potential to impact the revenue of the branded STALEVO. Generic competition often leads to price erosion and reduced market share for the original branded product. However, the settlement agreement allows Mylan to launch its generic version, which could mitigate some of the financial impact on Orion by ensuring a controlled transition to generic competition[1].

Future Outlook

The future outlook for STALEVO 150 remains positive despite the challenges posed by generic competition. The growing demand for Parkinson's disease treatments, coupled with the drug's established efficacy and safety profile, will continue to drive its market presence.

Research and Development

Continuous investments in research and development are crucial for maintaining market share. Orion Corporation's focus on product development and innovation will be key in sustaining the financial trajectory of STALEVO and other related products[2].

Market Expansion

Expanding into new markets, particularly in the Asia Pacific region, offers significant growth opportunities. Increasing awareness and improving healthcare infrastructure in these regions will drive demand for effective treatments like STALEVO 150[3].

Key Takeaways

• Market Size and Growth: The global Parkinson's disease market is projected to reach $11.66 billion by 2030, with the Levodopa/Carbidopa segment leading.
• Sales Performance: STALEVO had U.S. sales of approximately $138.6 million for the 12 months ending March 31, 2013.
• Regional Dynamics: North America and the Asia Pacific region are key markets due to advanced healthcare infrastructure and growing demand.
• Competitive Landscape: Generic competition from Mylan's authorized generic version will impact the branded product's market share.
• Financial Trajectory: STALEVO's revenue contribution is significant, but generic competition and R&D investments will influence future financial performance.

FAQs

What is STALEVO 150 used for?

STALEVO 150 is used for the treatment of Parkinson's disease, specifically as a substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual products[4].

How much did STALEVO generate in U.S. sales in 2013?

For the 12 months ending March 31, 2013, STALEVO had U.S. sales of approximately $138.6 million[1].

What are the key regions driving the growth of the Parkinson's disease market?

North America and the Asia Pacific region are the key drivers, due to advanced healthcare infrastructure and growing demand for Parkinson's disease treatments[3].

How does generic competition affect the financial trajectory of STALEVO?

Generic competition, such as Mylan's authorized generic version, can lead to price erosion and reduced market share for the branded product, impacting its revenue and financial performance[1].

What are the future growth opportunities for STALEVO 150?

Expanding into new markets, particularly in the Asia Pacific region, and continuous investments in research and development offer significant growth opportunities[2][3].

Sources

1. Mylan Announces STALEVO® Settlement Agreement - Fierce Pharma
2. Orion Group Interim Report 1-3/2009 - Orion
3. $11.66 Billion Parkinson's Disease Market Forecast, 2030 - GlobeNewswire
4. Stalevo - Drug Information from Guideline Central - Guideline Central