STALEVO 50 Drug Patent Profile

When do Stalevo 50 patents expire, and what generic alternatives are available?

Stalevo 50 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 50 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 50

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 50 at DailyMed

Recent Clinical Trials for STALEVO 50

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
SynAgile Corporation	Phase 2

See all STALEVO 50 clinical trials

Pharmacology for STALEVO 50

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

US Patents and Regulatory Information for STALEVO 50

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 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	AB	RX	Yes	Yes

Expired US Patents for STALEVO 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	6,500,867
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	4,963,590
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	6,797,732
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	5,446,194
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	5,135,950
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	5,112,861

EU/EMA Drug Approvals for STALEVO 50

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 50

See the table below for patents covering STALEVO 50 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
Yugoslavia	213587
Taiwan	I241187

Supplementary Protection Certificates for STALEVO 50

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 50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of STALEVO 50

Introduction to STALEVO 50

STALEVO 50, a combination medication containing carbidopa, levodopa, and entacapone, is specifically designed to treat symptoms of Parkinson's disease, such as muscle stiffness, tremors, and spasms. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Composition and Dosage

STALEVO 50 consists of 12.5 mg of carbidopa, 50 mg of levodopa, and 200 mg of entacapone. This combination simplifies treatment by providing sustained levels of levodopa in the blood, which is essential for managing Parkinson’s disease symptoms, particularly the phenomenon known as “wearing off”[4][5].

Market Context: Parkinson’s Disease

The global Parkinson’s disease market is projected to reach $11.66 billion by 2030, with the Levodopa/Carbidopa segment being the highest revenue-grossing segment. North America is expected to hold the highest revenue share due to advanced healthcare infrastructure and a high prevalence of Parkinson’s disease. The Asia Pacific region is anticipated to grow at the fastest CAGR due to its large population, increasing awareness of neurological disorders, and rising healthcare expenditure[3].

Sales Performance of STALEVO

For the 12 months ending March 31, 2013, STALEVO generated U.S. sales of approximately $138.6 million, according to IMS Health. This figure indicates the significant market presence and demand for this medication[1].

Competitive Landscape

The market for Parkinson’s disease treatments is competitive, with several medications and therapies available. However, STALEVO stands out due to its combination of carbidopa, levodopa, and entacapone, which provides greater and more sustained levels of levodopa in the blood. This unique formulation gives STALEVO an edge in managing the “wearing off” phenomenon, a common issue with traditional levodopa therapy[4].

Regulatory and Legal Aspects

In 2013, Mylan announced a settlement and license agreement that allowed the company to launch an authorized generic version of STALEVO immediately and its own ANDA (Abbreviated New Drug Application) product upon receiving final FDA approval. This agreement was subject to review by the U.S. Department of Justice and the Federal Trade Commission, highlighting the regulatory scrutiny and legal complexities involved in the pharmaceutical industry[1].

Clinical Benefits and Prescribing Flexibility

STALEVO significantly improves the ability of patients with Parkinson’s disease to control body movements and perform daily activities, especially those experiencing end-of-dose “wearing off.” The availability of six different dosage strengths, including STALEVO 50, provides physicians with more prescribing flexibility, enabling more individualized treatment approaches[4].

Expert Insights

According to Kapil D. Sethi, MD, Professor of Neurology and Director of the Movement Disorders Program at the Medical College of Georgia, "The new Stalevo 75 and 125 tablets are welcome additions to the treatment regimen for people with Parkinson’s disease who are experiencing the signs and symptoms of ‘wearing off’." This underscores the clinical value and the need for varied dosage options in managing Parkinson’s disease[4].

Financial Trajectory

The financial trajectory of STALEVO 50 is closely tied to the overall performance of the Parkinson’s disease market. With the market expected to grow significantly by 2030, medications like STALEVO are likely to see continued demand. The $138.6 million in U.S. sales for STALEVO in 2013 indicates a strong financial foundation. Additionally, Mylan’s pending ANDAs, including those for STALEVO, represent a significant potential market value, with 37 of these ANDAs being potential first-to-file opportunities representing $23 billion in annual brand sales[1].

Regional Market Dynamics

North America, with its advanced healthcare infrastructure and high prevalence of Parkinson’s disease, is a key market for STALEVO. The Asia Pacific region, however, is expected to grow rapidly due to its large population and increasing healthcare expenditure, making it a promising future market for this medication[3].

Challenges and Opportunities

Despite its clinical benefits, STALEVO faces challenges such as competition from other Parkinson’s disease treatments and regulatory hurdles. However, the growing awareness of neurological disorders and the need for more effective treatments present significant opportunities for market expansion.

Highlight: Clinical Impact

"Stalevo significantly improves the ability of patients with ‘wearing off’ to control body movements and perform daily activities, compared to traditional levodopa therapy." - Kapil D. Sethi, MD, Professor of Neurology, Director Movement Disorders Program at Medical College of GA[4].

Key Takeaways

• Market Growth: The global Parkinson’s disease market is projected to reach $11.66 billion by 2030.
• Sales Performance: STALEVO generated $138.6 million in U.S. sales for the 12 months ending March 31, 2013.
• Clinical Benefits: STALEVO provides greater and more sustained levels of levodopa, managing the “wearing off” phenomenon effectively.
• Regulatory Aspects: Mylan’s settlement and license agreement allowed for the launch of an authorized generic version of STALEVO.
• Prescribing Flexibility: Six different dosage strengths, including STALEVO 50, offer more individualized treatment options.

FAQs

1. What is STALEVO 50 used for? STALEVO 50 is used to treat symptoms of Parkinson’s disease, such as muscle stiffness, tremors, and spasms.

2. What are the components of STALEVO 50? STALEVO 50 contains 12.5 mg of carbidopa, 50 mg of levodopa, and 200 mg of entacapone.

3. How does STALEVO 50 differ from traditional levodopa therapy? STALEVO 50 combines carbidopa, levodopa, and entacapone to provide greater and more sustained levels of levodopa in the blood, managing the “wearing off” phenomenon more effectively.

4. What is the projected market size for Parkinson’s disease treatments by 2030? The global Parkinson’s disease market is projected to reach $11.66 billion by 2030.

5. Who are the key players involved in the distribution of STALEVO? STALEVO is originated and manufactured by Orion Corporation and marketed in the United States by Novartis Pharmaceuticals Corporation.

Sources

1. Fierce Pharma: Mylan Announces STALEVO® Settlement Agreement
2. RxList: Stalevo (Carbidopa, Levodopa and Entacapone)
3. GlobeNewswire: $11.66 Billion Parkinson's Disease Market Forecast, 2030
4. BioSpace: Two New Dosage Strengths Of Stalevo(R) Approved In The U.S.
5. Mayo Clinic: Carbidopa, entacapone, and levodopa (oral route)