STALEVO 125 Drug Patent Profile

Which patents cover Stalevo 125, and when can generic versions of Stalevo 125 launch?

Stalevo 125 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 125 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 125

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 125 at DailyMed

Recent Clinical Trials for STALEVO 125

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 125 clinical trials

Pharmacology for STALEVO 125

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

US Patents and Regulatory Information for STALEVO 125

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 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for STALEVO 125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,797,732
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,112,861
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,500,867
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,446,194

EU/EMA Drug Approvals for STALEVO 125

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 125

See the table below for patents covering STALEVO 125 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

Supplementary Protection Certificates for STALEVO 125

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 125 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STALEVO 125

Introduction to STALEVO 125

STALEVO 125, a combination medication of carbidopa, levodopa, and entacapone, is specifically designed to treat Parkinson’s disease, particularly in patients who experience the phenomenon of "wearing off" associated with traditional levodopa therapy. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Mechanism and Clinical Benefits

STALEVO 125 combines carbidopa, an inhibitor of aromatic amino acid decarboxylation, levodopa, an aromatic amino acid, and entacapone, a catechol-O-methyltransferase (COMT) inhibitor. This combination enhances the bioavailability of levodopa, providing more sustained levels in the blood and improving symptom control for patients with Parkinson’s disease[3][4][5].

Market Need and Target Population

Parkinson’s disease is a chronic and progressive neurological disorder affecting millions worldwide. Patients often experience motor symptoms such as muscle stiffness, tremors, and spasms, which can significantly impact their quality of life. STALEVO 125 addresses the need for a medication that can manage these symptoms more effectively, especially in patients experiencing "wearing off" from traditional levodopa therapy[4].

Market Competition

The market for Parkinson’s disease treatments is competitive, with various medications and combinations available. However, STALEVO 125 stands out due to its unique formulation that includes both carbidopa and entacapone, which enhances the efficacy of levodopa. This differentiation allows it to capture a significant share of the market, particularly among patients who require more sustained symptom control[4].

Regulatory Approvals and Updates

STALEVO 125 has received FDA approvals for several dosage strengths, including the 125 mg formulation. The approval of new dosage strengths, such as the 75 mg and 125 mg tablets in 2008, has provided greater dosing flexibility for physicians and patients, further solidifying its market position[4].

Financial Performance

For the 12 months ending March 31, 2013, STALEVO had U.S. sales of approximately $138.6 million, indicating a strong financial performance. This revenue is a testament to the drug's effectiveness and its acceptance by both physicians and patients[1].

Settlement Agreements and Generic Versions

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 not only resolved pending litigation but also paved the way for generic competition, which can impact the financial trajectory of the branded version[1].

Impact of Generic Competition

The introduction of generic versions can significantly affect the sales of branded medications. However, the complexity of STALEVO 125's formulation and its specific clinical benefits may help maintain a loyal patient base and continue to generate substantial revenue, albeit at a potentially reduced level compared to pre-generic competition[1].

Market Trends and Future Outlook

The Parkinson’s disease treatment market is expected to grow due to an increasing patient population and advancements in treatment options. STALEVO 125, with its proven efficacy and flexibility in dosing, is well-positioned to continue playing a significant role in this market. However, the landscape will likely evolve with new treatments and therapies emerging, which could influence its market share and financial performance[4].

Patient and Physician Preferences

Patient and physician preferences play a crucial role in the market dynamics of any medication. STALEVO 125's ability to simplify treatment regimens by combining multiple components into a single tablet and its effectiveness in managing "wearing off" symptoms have made it a preferred choice among many healthcare providers and patients[4].

Safety and Efficacy Profile

While STALEVO 125 offers significant clinical benefits, it also comes with potential side effects such as daytime drowsiness, somnolence, syncope, and the exacerbation of dyskinesia. These factors must be carefully managed by healthcare providers to ensure the medication is used safely and effectively[3].

Dosage and Administration

The optimum daily dosage of STALEVO 125 must be determined by careful titration in each patient. The medication is available in various strengths, and the maximum recommended daily dose depends on the strength used. This flexibility allows for customized treatment approaches, enhancing patient outcomes[3].

Conclusion

STALEVO 125 has established itself as a vital treatment option for patients with Parkinson’s disease, particularly those experiencing "wearing off" symptoms. Its unique formulation, regulatory approvals, and strong financial performance have solidified its position in the market. However, the introduction of generic versions and evolving market trends will continue to shape its financial trajectory.

Key Takeaways

• Clinical Benefits: STALEVO 125 combines carbidopa, levodopa, and entacapone to provide sustained symptom control for Parkinson’s disease patients.
• Market Need: Addresses the need for effective management of "wearing off" symptoms associated with traditional levodopa therapy.
• Financial Performance: Generated $138.6 million in U.S. sales for the 12 months ending March 31, 2013.
• Regulatory Approvals: Received FDA approvals for various dosage strengths, including the 125 mg formulation.
• Generic Competition: The introduction of generic versions may impact sales but is mitigated by the drug's unique formulation and clinical benefits.
• Market Trends: The Parkinson’s disease treatment market is expected to grow, with STALEVO 125 remaining a significant player.

FAQs

Q: What is STALEVO 125 used for? A: STALEVO 125 is used to treat Parkinson’s disease, particularly in patients who experience "wearing off" symptoms from traditional levodopa therapy.

Q: What are the components of STALEVO 125? A: STALEVO 125 is a combination of carbidopa, levodopa, and entacapone.

Q: How does STALEVO 125 improve symptom control? A: STALEVO 125 enhances the bioavailability of levodopa, providing more sustained levels in the blood and improving symptom control.

Q: What are the potential side effects of STALEVO 125? A: Potential side effects include daytime drowsiness, somnolence, syncope, and the exacerbation of dyskinesia.

Q: How is the dosage of STALEVO 125 determined? A: The optimum daily dosage of STALEVO 125 must be determined by careful titration in each patient.

Sources

1. Mylan Announces STALEVO® Settlement Agreement - Fierce Pharma
2. Stalevo - accessdata.fda.gov
3. Prescribing Information - accessdata.fda.gov
4. Two New Dosage Strengths Of Stalevo(R) Approved In ... - BioSpace
5. Stalevo (Carbidopa, Levodopa and Entacapone) - RxList