STALEVO 75 Drug Patent Profile

When do Stalevo 75 patents expire, and when can generic versions of Stalevo 75 launch?

Stalevo 75 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 75 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 75

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 75 at DailyMed

Recent Clinical Trials for STALEVO 75

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 75 clinical trials

Pharmacology for STALEVO 75

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

US Patents and Regulatory Information for STALEVO 75

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 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for STALEVO 75

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	6,797,732
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	5,112,861
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	6,500,867

EU/EMA Drug Approvals for STALEVO 75

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 75

See the table below for patents covering STALEVO 75 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

Supplementary Protection Certificates for STALEVO 75

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

STALEVO 75 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STALEVO 75

Introduction to STALEVO 75

STALEVO 75, a combination drug consisting of carbidopa, levodopa, and entacapone, is specifically designed to treat patients with idiopathic Parkinson's disease. It is particularly useful for patients experiencing end-of-dose "wearing off" symptoms, a common issue in Parkinson’s disease management[4].

Market Context: Parkinson's Disease

The Parkinson's disease market is anticipated to exhibit significant growth, driven by advancements in diagnostic techniques, increased awareness, and a rising number of reported cases. As of 2023, the market size for Parkinson's disease in the seven major markets (7MM) was estimated at USD 3.2 billion, with the United States accounting for 45% of the diagnosed prevalent cases[3].

Product Approval and Launch

STALEVO 75 was approved by the U.S. Food and Drug Administration (FDA) in June 2003 and is marketed in the United States by Novartis Pharmaceuticals Corporation. In 2008, two new dosage strengths, Stalevo 75 and 125, were approved, providing greater dosing flexibility for patients[4].

Clinical Significance and Usage

STALEVO 75 simplifies treatment by combining levodopa with the enzyme inhibitors carbidopa and entacapone, ensuring more sustained levels of levodopa in the blood. This formulation helps patients with "wearing off" symptoms to better control their body movements and perform daily activities compared to traditional levodopa therapy[4].

Dosage and Administration

The drug is available in various strengths, including Stalevo 75, which contains 18.75 mg of carbidopa, 75 mg of levodopa, and 200 mg of entacapone. Patients are advised to swallow the tablets whole, with a maximum of one tablet per dosing interval. The dosage can be adjusted based on the patient's previous carbidopa/levodopa and entacapone regimen[2].

Financial Performance

Sales and Revenue

For the 12 months ending March 31, 2013, STALEVO had U.S. sales of approximately $138.6 million, according to IMS Health. This figure indicates the drug's significant market presence and revenue generation within the Parkinson's disease treatment segment[1].

Generic Competition

In 2013, Mylan Inc. announced a settlement and license agreement with Orion Corporation, allowing Mylan to launch an authorized generic version of STALEVO immediately and its own ANDA product upon receiving final FDA approval. This move could potentially impact the market dynamics and pricing of STALEVO 75, as generic competition often leads to reduced prices and increased market accessibility[1].

Market Share and Competition

The Parkinson's disease market is dominated by combination therapies, with STALEVO being one of the key players. However, the market is highly competitive, with several other treatments available, including those from companies like UCB Biopharma SRL, Novartis, Annovis Bio, and AbbVie. The emergence of new therapies, such as Supernus Pharmaceuticals' SPN-830 and AbbVie's tavapadon, is expected to further shape the market landscape[3].

Future Outlook

The Parkinson's disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by the introduction of new therapies and advancements in diagnostic techniques. STALEVO 75, with its established presence and clinical benefits, is likely to remain a significant player in this growing market. However, the drug's market share and financial trajectory will be influenced by the entry of new treatments and the ongoing competition within the sector[3].

Key Takeaways

• Market Growth: The Parkinson's disease market is poised for steady growth, driven by advancements and increasing awareness.
• Clinical Significance: STALEVO 75 offers significant clinical benefits by providing sustained levodopa levels, helping patients manage "wearing off" symptoms.
• Financial Performance: STALEVO generated substantial revenue, with U.S. sales of $138.6 million in 2013.
• Generic Competition: The entry of generic versions could impact pricing and market dynamics.
• Future Outlook: The drug is expected to remain a key player, but its market share will be influenced by new therapies and competition.

FAQs

What is STALEVO 75 used for?

STALEVO 75 is used to treat patients with idiopathic Parkinson's disease, particularly those experiencing end-of-dose "wearing off" symptoms.

Who manufactures STALEVO 75?

STALEVO 75 is originated and manufactured by Orion Corporation and marketed in the United States by Novartis Pharmaceuticals Corporation.

What are the active ingredients in STALEVO 75?

The active ingredients in STALEVO 75 are carbidopa, levodopa, and entacapone.

How does STALEVO 75 differ from traditional levodopa therapy?

STALEVO 75 combines levodopa with the enzyme inhibitors carbidopa and entacapone, providing more sustained levels of levodopa in the blood and better symptom control.

What is the expected growth rate of the Parkinson's disease market?

The Parkinson's disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.

Sources:

1. Mylan Announces STALEVO® Settlement Agreement - Fierce Pharma
2. STALEVO 75 Prescription & Dosage Information - eMPR.com
3. Parkinson's Disease Market is Expected to Showcase a Significant Growth - GlobeNewswire
4. Two New Dosage Strengths Of Stalevo(R) Approved In The U.S. - BioSpace
5. Stalevo - FDA Label[5]