FOSCARBIDOPA; FOSLEVODOPA - Generic Drug Details

What are the generic sources for foscarbidopa; foslevodopa and what is the scope of freedom to operate?

Foscarbidopa; foslevodopa is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Foscarbidopa; foslevodopa has eighty-eight patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for FOSCARBIDOPA; FOSLEVODOPA

International Patents:	88
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	FOSCARBIDOPA; FOSLEVODOPA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FOSCARBIDOPA; FOSLEVODOPA

Constraining patent/regulatory exclusivity:

10,730,895

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FOSCARBIDOPA; FOSLEVODOPA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AbbVie	Phase 1

See all FOSCARBIDOPA; FOSLEVODOPA clinical trials

US Patents and Regulatory Information for FOSCARBIDOPA; FOSLEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	12,251,365
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	10,174,061		Y
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	10,730,895			Y
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	9,446,059		Y	Y

International Patents for FOSCARBIDOPA; FOSLEVODOPA

Country	Patent Number	Title	Estimated Expiration
Argentina	102389
Australia	2015335941
Australia	2021201414
Australia	2023210650
Australia	2025238004
Brazil	112017008198

Supplementary Protection Certificates for FOSCARBIDOPA; FOSLEVODOPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	PA2023519	Lithuania		PRODUCT NAME: FOSLEVODOPOS IR FOSKARBIDOPOS KOMPOZICIJA, KURIU KIEKVIENA YRA VISU FORMU SAUGOMA PAGRINDINIO PATENTO; REGISTRATION NO/DATE: AT, 141371 20220825
3209302	C202330028	Spain		PRODUCT NAME: COMBINACION DE FOSLEVODOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA Y FOSCARBIDOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISM.; NATIONAL AUTHORISATION NUMBER: 88677-SE/H/0415/003/DC; DATE OF AUTHORISATION: 20230220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 141371; DATE OF FIRST AUTHORISATION IN EEA: 20220825
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901
3209302	CA 2023 00015	Denmark		PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
3209302	122023000043	Germany		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON MIT FOSCARBIDOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; NAT. REGISTRATION NO/DATE: 7005976.00.00 20230223; FIRST REGISTRATION: OESTERREICH 141371 20220825
3209302	202340008	Slovenia		PRODUCT NAME: COMBINATION OF FOSLEVODOPA OR ITS PHARMACEUTICALLY ACCEPTABLE SALT AND FOSCARBIDOPA OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: H/05/00514/002; DATE OF NATIONAL AUTHORISATION: 20221215; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 141371; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20220825; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: AT

Last updated: February 13, 2026

What Are Foscarbidopa and Foslevodopa?

Foscarbidopa and foslevodopa are prodrugs designed to improve the delivery of levodopa, the primary treatment for Parkinson’s disease. Foslevodopa is a prodrug of levodopa developed for intravenous (IV) administration, aiming to provide more controlled and rapid onset. Foscarbidopa is associated with foslevodopa but primarily functions as a formulation adjunct to optimize levodopa delivery by inhibiting peripheral conversion, thus reducing motor fluctuations. Both aim to address limitations of oral levodopa therapy, including variable absorption and peripheral side effects.

What Is the Current Market Size and Growth Trajectory?

The Parkinson’s disease (PD) therapeutics market is valued at approximately $4.2 billion in 2023, with an annual compound growth rate (CAGR) of around 4.1% expected through 2030. Nearly 10 million people globally live with PD, with the market driven by aging populations in North America, Europe, and Asia-Pacific.

Market segments: Levodopa formulations constitute more than 70% of the PD drug market. Innovations such as foscarbidopa and foslevodopa target this segment by offering alternatives to oral delivery, especially for advanced PD patients experiencing motor fluctuations.

Growth drivers:

• Increasing prevalence of PD among aging populations.
• Limitations of existing oral levodopa with issues such as "wearing off" phenomenon and dyskinesias.
• Development of continuous infusion therapies to stabilize plasma levodopa levels.
• Advances in drug delivery technology leading to more effective and patient-friendly options.

How Do Pharmacological Innovations Influence Market Dynamics?

Foscarbidopa and foslevodopa are part of a broader shift toward infusion and continuous infusion therapies. Their introduction could disrupt existing treatment paradigms by offering:

• Improved pharmacokinetics: Reduced plasma level fluctuations.
• Reduced motor complications: Minimized dyskinesia.
• Enhanced patient compliance: Fewer doses or improved delivery methods.

Currently, apomorphine infusion and levodopa-carbidopa intestinal gel (Duopa) lead the infusion therapy market. Foslevodopa, with IV administration, proposes to enhance or supplement these options, especially in hospital settings or advanced PD cases.

The commercialization of these drugs depends on clinical trial outcomes and regulatory approvals. Their entry could alter the competitive landscape, especially if they demonstrate significant efficacy or patient convenience over existing approaches.

What Are the Regulatory and Commercialization Challenges?

Regulatory pathway: Foscarbidopa and foslevodopa have advanced through early-phase clinical trials, but approval timelines remain uncertain. The FDA and EMA require data on safety, efficacy, and manufacturing quality. Their status as prodrugs means additional scrutiny around pharmacodynamic profiles.

Pricing and reimbursement: IV formulations tend to carry higher costs than oral medications. Reimbursement policies could influence market adoption, with hospital or infusion center payments being critical components.

Clinical adoption: Physicians require evidence that these formulations outperform or provide significant benefits over existing therapies. Adoption will depend on clinical trial outcomes, ease of administration, and side effect profiles.

What Are the Financial Trends and Investment Opportunities?

Investors increasingly view neurology drugs, including PD therapies, as promising sectors. Several biotech companies developing levodopa prodrugs or infusion therapies have secured substantial funding. For example, Imbrium Therapeutics raised over $50 million to develop its levodopa formulations.

Key considerations:

• Pipeline progress: Companies advancing foscarbidopa and foslevodopa must demonstrate efficacy and safety in pivotal trials.
• Market penetration: Entry barriers include competition from established levodopa formulations and infusion systems.
• Pricing strategy: Given IV formulations' higher costs, payers may negotiate pricing, influencing overall revenue streams.

Are There Specific Competitive Threats?

Yes. Existing therapies like levodopa-carbidopa intestinal gel (Duopa), apomorphine infusions, and continuous subcutaneous levodopa delivery devices offer comparable benefits. The efficacy, convenience, and safety profiles of foscarbidopa and foslevodopa will determine their competitive positioning.

Emerging gene therapies and neurostimulation devices further diversify treatment options and could influence long-term market dynamics.

How Do Geographic and Policy Factors Affect Market Trajectory?

The United States and Europe represent primary markets due to high PD prevalence and established healthcare infrastructure. Regulatory pathways are well-defined but rigorous.

Emerging markets, particularly in Asia, present growth opportunities driven by increasing PD diagnosis rates but face hurdles related to healthcare access and regulatory infrastructure.

Government policies promoting innovation in neurodegenerative disorders, along with favorable reimbursement landscapes, could accelerate market penetration.

What Is the Timeline for Market Entry and Adoption?

• Clinical trial completion: Targeted for 2024–2025.
• Regulatory submission: Anticipated in 2025–2026, contingent on trial outcomes.
• Market launch: Potential in late 2026 or 2027, subject to approvals.

Physician adoption hinges on trial data demonstrating clear advantages over current therapies, alongside cost considerations and patient preferences.

Final Summary

Foscarbidopa and foslevodopa aim to enhance PD management by providing more controlled levodopa delivery, potentially reducing motor fluctuations. Their success depends on clinical efficacy, regulatory approval timing, and payer acceptance. The PD pharmaceutical market is positioned for steady growth, with infusion therapies capturing increasing attention. Early clinical data, competitive landscape, and regulatory developments will shape their commercial trajectory over the next several years.

Key Takeaways

• Foslevodopa’s IV delivery could revolutionize advanced PD treatment, countering current limitations of oral formulations.
• Market size exceeds $4 billion, with growth fueled by demographic trends and unmet needs in PD care.
• Commercial success relies on clinical trial outcomes, regulatory approval, and reimbursement strategies.
• Existing infusion therapies pose competition; differentiation will hinge on efficacy, safety, and patient convenience.
• Regulatory timelines project late 2020s for market entry, with adoption driven by clinical benefits and health policy alignment.

FAQs

Q1: What advantages do foscarbidopa and foslevodopa offer over existing therapies?
They provide continuous levodopa delivery, potentially stabilizing plasma levels and reducing motor fluctuations and dyskinesias associated with oral therapy.

Q2: Which markets are most likely to adopt these drugs initially?
The U.S. and Europe are primary markets, given established neurodegenerative treatment infrastructure and regulatory pathways. Asian markets may follow as awareness and healthcare access improve.

Q3: How do regulatory agencies view prodrug formulations like foscarbidopa and foslevodopa?
Regulators assess safety, efficacy, and manufacturing standards. Prodrugs require evidence of predictable pharmacokinetics and benefit over existing options.

Q4: What are the main competitors to foslevodopa?
Levodopa-carbidopa intestinal gel, apomorphine infusion, and subcutaneous levodopa patches are leading infusion therapies serving similar patient populations.

Q5: When might these drugs reach the market?
Clinical trials are ongoing, with potential regulatory submissions around 2025–2026, and market availability likely in 2027 if approved.

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Citations
[1] Market Research Future, "Parkinson’s Disease Drugs Market," 2023.
[2] Grand View Research, "Neurodegenerative Disease Therapeutics Market," 2023.