LEVODOPA - Generic Drug Details

What are the generic drug sources for levodopa and what is the scope of patent protection?

Levodopa is the generic ingredient in four branded drugs marketed by Valeant Pharm Intl, Shire, Roche, and Merz Pharms, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levodopa has one hundred and three patent family members in twenty-two countries.

There are eighteen drug master file entries for levodopa. One supplier is listed for this compound.

Summary for LEVODOPA

International Patents:	103
US Patents:	6
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	445
Patent Applications:	6,932
What excipients (inactive ingredients) are in LEVODOPA?	LEVODOPA excipients list
DailyMed Link:	LEVODOPA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEVODOPA

Constraining patent/regulatory exclusivity:

8,545,878

Dosage:

POWDER;INHALATION

^*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 LEVODOPA

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

Sponsor	Phase
Centro Hospitalar de Lisboa Central	N/A
The Affiliated Hospital of Qingdao University	Phase 1
UCB Biopharma SRL	Phase 2

See all LEVODOPA clinical trials

Pharmacology for LEVODOPA

Drug Class

Aromatic Amino Acid

Medical Subject Heading (MeSH) Categories for LEVODOPA

Antiparkinson Agents

Dopamine Agents

Anatomical Therapeutic Chemical (ATC) Classes for LEVODOPA

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for LEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	RE43711
Roche	LARODOPA	levodopa	TABLET;ORAL	016912-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	LARODOPA	levodopa	CAPSULE;ORAL	016912-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	LARODOPA	levodopa	TABLET;ORAL	016912-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for LEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	7,182,961
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	6,514,482
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	8,586,093
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	8,404,276
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	8,628,754

EU/EMA Drug Approvals for LEVODOPA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Acorda Therapeutics Ireland Limited	Inbrija	levodopa	EMEA/H/C/004786 Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.	Authorised	no	no	no	2019-09-19

International Patents for LEVODOPA

Country	Patent Number	Title	Estimated Expiration
South Korea	20220054703	폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Japan	2005511628
Spain	2609482
European Patent Office	2916826	POUDRES PULMONAIRES DE DENSITÉ ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
South Korea	102389785

Supplementary Protection Certificates for LEVODOPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226

LEVODOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levodopa

Introduction

Levodopa, a precursor to dopamine, is the cornerstone of treatment for Parkinson's disease (PD), a neurodegenerative disorder characterized by the degeneration of dopaminergic cells in the brain. The market for levodopa is witnessing significant growth, driven by several key factors.

Market Size and Growth

The global levodopa market was valued at $1.7 billion in 2022 and is projected to reach $2.9 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.1% from 2023 to 2032[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Parkinson's Disease

The escalating prevalence of Parkinson's disease is a primary driver of the levodopa market. As the global population ages, the incidence of PD is expected to rise, leading to an increased demand for therapeutic interventions[4].

Rising Healthcare Expenditure

Increased healthcare expenditure, particularly in developing regions, has improved accessibility to medications like levodopa. This heightened investment in healthcare infrastructure and services facilitates enhanced availability and affordability of levodopa, driving market growth[1][4].

Development of Novel Formulations and Drug Delivery Methods

The development of innovative formulations and efficient drug delivery methods is anticipated to propel market growth. These advancements enhance treatment efficacy, improve patient adherence, and address existing challenges associated with PD management[1][4].

Market Segmentation

Form

The tablets sub-segment accounted for the largest global levodopa market share of 36.0% in 2022 and is expected to grow at the highest CAGR of 7.0% during the forecast period. The convenience, affordability, and widespread adoption of levodopa tablets make them a preferred choice among patients[4].

Route of Administration

The oral sub-segment held a 57.7% market share in 2022 and is expected to dominate the market throughout the forecast period. Oral administration is preferred due to its convenience, familiarity, and widespread adoption among patients and healthcare providers[4].

Distribution Channels

Retail pharmacies accounted for a 34.1% market share in 2022 and are predicted to witness significant growth during the forecast period. The widespread availability of retail pharmacies offers convenient access to levodopa for patients managing PD[4].

Regional Analysis

North America is expected to hold the major market share of 41.0% by 2032, driven by advanced healthcare infrastructure, high healthcare expenditure, and a large patient population[1].

Challenges and Restraints

Safety and Side Effects

Concerns regarding safety and side effects associated with levodopa, such as dyskinesias, "wearing off" phenomena, and other motor complications, may pose challenges to market expansion. These side effects can limit dosing and impact the quality of life for patients with advanced PD[2][5].

Complexity in Treatment Regimens

As PD symptoms progress, the treatment evolves, adding complexity to the drug regimen. In advanced PD, levodopa is less effective, with only 20% of patients experiencing a 30% motor improvement, and 50% seeing less than a 15% improvement. This complexity can affect patient adherence and treatment outcomes[2].

Technological Advancements and Opportunities

Innovative Drug Delivery Methods

Technological advancements in drug delivery, such as the development of extended-release formulations and continuous infusion systems, present lucrative opportunities for market expansion. These innovations aim to improve the therapeutic time window and reduce side effects associated with levodopa therapy[1][4].

Synergistic Effects of Other Medications

Research has shown that the use of serotonin autoreceptor agonists can have a synergistic effect with levodopa, potentially lengthening the therapeutic time window and reducing levodopa-induced dyskinesias. This presents an opportunity for combination therapies that could enhance treatment efficacy[5].

Competitive Landscape

The levodopa market is characterized by a competitive landscape with several key players working towards the growth of the market. The market dynamics are influenced by factors such as competitive rivalry, bargaining power of buyers and suppliers, threats of new entrants, and the emergence of substitutes, as analyzed through Porter’s five forces model[1].

Financial Trajectory

The financial trajectory of the levodopa market is positive, with a projected growth from $1.7 billion in 2022 to $2.9 billion by 2032. This growth is supported by increasing healthcare expenditure, the development of novel formulations, and the rising demand for therapeutic interventions for PD[1][4].

Key Takeaways

• The global levodopa market is expected to reach $2.9 billion by 2032, growing at a CAGR of 6.1%.
• North America will hold the major market share by 2032.
• The tablets sub-segment and oral route of administration are expected to dominate the market.
• Rising healthcare expenditure and the development of novel formulations are key drivers of market growth.
• Safety and side effects associated with levodopa pose challenges to market expansion.
• Technological advancements in drug delivery present lucrative opportunities for market growth.

FAQs

Q: What is the projected market size of the levodopa market by 2032? A: The global levodopa market is projected to reach $2.9 billion by 2032[1][4].

Q: Which region is expected to hold the major market share of the levodopa market by 2032? A: North America is expected to hold the major market share of 41.0% by 2032[1].

Q: What are the primary drivers of the levodopa market growth? A: The primary drivers include the escalating prevalence of Parkinson's disease, increasing healthcare expenditure, and the development of novel formulations and efficient drug delivery methods[1][4].

Q: What are the common side effects associated with long-term levodopa therapy? A: Common side effects include dyskinesias, "wearing off" phenomena, and other motor complications such as involuntary movements and sudden dose failures[2][5].

Q: How do technological advancements impact the levodopa market? A: Technological advancements in drug delivery, such as extended-release formulations and continuous infusion systems, aim to improve treatment efficacy and reduce side effects, presenting lucrative opportunities for market growth[1][4].

Sources

1. Allied Market Research - "Levodopa Market Projected to Reach $2.9 Billion by 2032"
2. Stanford Parkinson's Blog - "The Parkinson's Journey: Understanding Progression"
3. EIN Presswire - "Trends, Opportunities, Future Investments, and Forecast Analysis for the Levodopa Market to the Years 2022-2030"
4. GlobeNewswire - "Levodopa Market to Reach $2.9 Billion Globally By 2032 at 6.1% CAGR"
5. Frontiers in Integrative Neuroscience - "Mathematical Insights into the Effects of Levodopa"