STALEVO 200 Drug Patent Profile

When do Stalevo 200 patents expire, and when can generic versions of Stalevo 200 launch?

Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 200 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 200

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 200 at DailyMed

Recent Clinical Trials for STALEVO 200

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 200 clinical trials

Pharmacology for STALEVO 200

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

US Patents and Regulatory Information for STALEVO 200

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 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	AB	RX	Yes	Yes

Expired US Patents for STALEVO 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007

EU/EMA Drug Approvals for STALEVO 200

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 200

See the table below for patents covering STALEVO 200 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 200

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 200 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of STALEVO

Introduction

STALEVO, a combination drug containing carbidopa, levodopa, and entacapone, is used to treat adult patients with Parkinson's disease, particularly those experiencing end-of-dose motor fluctuations. Here, we delve into the market dynamics and financial trajectory of STALEVO, highlighting its performance, market impact, and key financial metrics.

Indication and Pharmacology

STALEVO is indicated for the treatment of adult patients with Parkinson's disease who are experiencing fluctuations in their motor responses to levodopa/DDC inhibitor treatment. The drug combines carbidopa, levodopa, and entacapone, with entacapone slowing the clearance of levodopa from the bloodstream, thereby increasing its availability and effectiveness[4].

Market Performance

Sales Figures

As of 2013, STALEVO had significant sales in the U.S. market, with revenues of approximately $138.6 million for the 12 months ending March 31, 2013, according to IMS Health[1].

Competitive Landscape

The Parkinson's disease treatment market is competitive, with various drugs and combinations available. However, STALEVO's unique formulation and efficacy profile have allowed it to maintain a strong market presence. The entry of generic versions, such as Mylan's authorized generic and ANDA product, has also influenced the market dynamics, providing patients with more affordable options[1].

Financial Trajectory

Revenue Growth

STALEVO has been a significant contributor to the revenue of its original developer, Orion Corporation. In the early 2000s, the drug played a crucial role in Orion's financial growth, with its sales driving the company's EBIT (Earnings Before Interest and Taxes) growth. For instance, in 2007, the increased sales of STALEVO contributed to Orion's stable EBIT despite increased investments in R&D and sales organization development[2].

Impact of Generic Competition

The settlement agreement between Mylan and Orion allowed Mylan to launch an authorized generic version of STALEVO immediately and its own ANDA product upon receiving final FDA approval. This move has likely impacted the revenue of the branded version of STALEVO, as generic competition often leads to price reductions and market share erosion[1].

Licensing and Partnerships

Settlement Agreement

The settlement and license agreement between Mylan and Orion Corporation is a significant financial and strategic move. This agreement not only resolved pending litigation but also allowed Mylan to enter the market with a generic version, potentially altering the revenue streams for both companies. The terms of the agreement, while confidential, are subject to review by regulatory bodies such as the U.S. Department of Justice and the Federal Trade Commission[1].

Regional Performance

Europe and Other Markets

STALEVO's performance varies across different regions. In Europe, the drug has been a part of Orion's specialty products portfolio, which includes generic prescription drugs, self-care products, and biosimilars. The COVID-19 pandemic had a mixed impact on these products, with some experiencing increased demand due to hoarding, while others saw declines due to pandemic restrictions[3].

Financial Metrics and Trends

Operating Profit and Net Sales

Orion's financial statements reflect the impact of STALEVO on the company's overall performance. For example, in 2007, the operating profit (EBIT) was significantly influenced by the sales growth of STALEVO, contributing to a stable EBIT despite increased R&D and sales organization investments[2].

Recent Financial Performance

In more recent years, Orion's financial performance has been influenced by a broader portfolio of products, including new proprietary drugs like Nubeqa for non-metastatic castration-resistant prostate cancer. However, the legacy products like STALEVO continue to contribute to the company's net sales, albeit with the impact of generic competition and market dynamics[3].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the pharmaceutical industry, including the sales of STALEVO. In some regions, there was a spike in demand for certain products due to hoarding, while in others, sales were negatively affected by pandemic restrictions and supply chain disruptions. The overall impact on STALEVO's sales was mixed, reflecting broader market trends during the pandemic[3].

Key Takeaways

• Market Presence: STALEVO has maintained a strong market presence in the treatment of Parkinson's disease.
• Financial Contribution: The drug has been a significant contributor to Orion's revenue and operating profit.
• Generic Competition: The entry of generic versions has altered the market dynamics and financial trajectory.
• Regional Variations: Performance varies across different regions, influenced by local market conditions and the COVID-19 pandemic.
• Licensing Agreements: Settlements and licensing agreements have played a crucial role in shaping the drug's market and financial landscape.

FAQs

What is STALEVO used for?

STALEVO is used for the treatment of adult patients with Parkinson's disease, particularly those experiencing end-of-dose motor fluctuations not stabilized on levodopa/DDC inhibitor treatment[4].

How does STALEVO work?

STALEVO combines carbidopa, levodopa, and entacapone. Entacapone slows the clearance of levodopa from the bloodstream, increasing its availability and effectiveness[4].

What was the U.S. sales figure for STALEVO in 2013?

The U.S. sales for STALEVO were approximately $138.6 million for the 12 months ending March 31, 2013[1].

How has generic competition affected STALEVO?

The entry of generic versions, such as Mylan's authorized generic and ANDA product, has likely reduced the market share and revenue of the branded version of STALEVO[1].

What impact did the COVID-19 pandemic have on STALEVO sales?

The pandemic had a mixed impact, with some regions experiencing increased demand due to hoarding, while others saw declines due to pandemic restrictions and supply chain disruptions[3].

Sources

1. Mylan Announces STALEVO® Settlement Agreement - Fierce Pharma
2. Orion Group Financial Statements 2007 - Orion
3. Financial Statement documents 2020 - Orion
4. Stalevo 200 mg/50 mg/200 mg Film-coated Tablets - Medicines.org.uk