CARBIDOPA; LEVODOPA - Generic Drug Details

What are the generic drug sources for carbidopa; levodopa and what is the scope of freedom to operate?

Carbidopa; levodopa is the generic ingredient in nine branded drugs marketed by Impax, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Rising, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-six NDAs. There are twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has sixty-four patent family members in fifteen countries.

Thirty-five suppliers are listed for this compound.

Summary for CARBIDOPA; LEVODOPA

International Patents:	64
US Patents:	22
Tradenames:	9
Applicants:	26
NDAs:	36
Finished Product Suppliers / Packagers:	35
Clinical Trials:	185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARBIDOPA; LEVODOPA
DailyMed Link:	CARBIDOPA; LEVODOPA at DailyMed

Recent Clinical Trials for CARBIDOPA; LEVODOPA

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	Phase 1
Bronx VA Medical Center	Phase 1
VistaGen Therapeutics, Inc.	Phase 2

See all CARBIDOPA; LEVODOPA clinical trials

Pharmacology for CARBIDOPA; LEVODOPA

Drug Class

Aromatic Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for CARBIDOPA; LEVODOPA

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

Paragraph IV (Patent) Challenges for CARBIDOPA; LEVODOPA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYTARY	Extended-release Capsules	carbidopa; levodopa	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg	203312	1	2015-06-24
RYTARY	Extended-release Capsules	carbidopa; levodopa	61.25 mg/245 mg	203312	1	2015-06-10

US Patents and Regulatory Information for CARBIDOPA; LEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	210341-002	Jun 5, 2019	AB	RX	No	No
Mylan	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	090324-002	Sep 28, 2009	AB	RX	No	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992		DISCN	Yes	No
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	9,533,046		Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	9,089,607		Y
Impax Labs	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, ORALLY DISINTEGRATING;ORAL	090631-001	Jun 8, 2010		DISCN	No	No

Expired US Patents for CARBIDOPA; LEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982	3,769,424
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015	7,094,427
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	3,769,424
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	3,169,424
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	4,832,957
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	3,781,415
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	3,769,424

EU/EMA Drug Approvals for CARBIDOPA; LEVODOPA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amneal Pharma Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

International Patents for CARBIDOPA; LEVODOPA

Country	Patent Number	Title	Estimated Expiration
Israel	263053	תערובות שחרור מבוקרות של ושמושיהן levodopa (Controlled release formulation of levodopa and uses thereof)
South Korea	20230124622
Israel	272772	מוקו-דביק, פורמולציות שחרור מבוקרות של לבדופה ו / או אסטרים של לבדופה ושימושים בהם (Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof)
Japan	6033373
South Africa	201005309	CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF
Japan	2021517128	レボドパ分割用量組成物および使用
Israel	244920	מוקו-דביק, פורמולציות שחרור מבוקרות של לבדופה ו / או אסטרים של לבדופה ושימושים בהם (Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof)

CARBIDOPA; LEVODOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbidopa/Levodopa

Introduction to Carbidopa/Levodopa

Carbidopa and levodopa, often combined as carbidopa/levodopa, are cornerstone medications in the management of Parkinson's disease. Levodopa, a precursor to dopamine, crosses the blood-brain barrier and is converted into dopamine, alleviating motor symptoms such as tremors, stiffness, and bradykinesia. Carbidopa inhibits the enzyme aromatic L-amino acid decarboxylase, which prevents levodopa from being converted into dopamine outside the brain, thereby enhancing the bioavailability of levodopa and reducing side effects[1][4].

Market Size and Growth

The global levodopa market, which includes carbidopa/levodopa formulations, 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].

Driving Factors

Rising Prevalence of Parkinson's Disease

The increasing prevalence of Parkinson's disease, driven by factors such as longer life expectancy and changing lifestyle patterns, is a significant driver of the levodopa market. As the global population ages, the demand for effective treatments for Parkinson's disease is on the rise[1][4].

Healthcare Expenditure and Infrastructure

The robust healthcare infrastructure and advanced medical research facilities in regions like North America foster innovation in Parkinson's disease management, including the development of novel levodopa formulations. Supportive healthcare policies and reimbursement frameworks also ensure widespread access to these medications[1][4].

Technological Advancements

Advancements in drug delivery systems, such as the Accordion Pill™ and continuous infusion formulations like ND0612, are enhancing the efficacy and convenience of levodopa therapy. These innovations provide stable plasma levels of levodopa, reducing motor fluctuations and improving patient outcomes[2][5].

Market Segmentation

By Form

The tablets segment of the levodopa market accounted for the highest market share in 2022. Extended-release and combination formulations with carbidopa are particularly popular due to their convenience and improved bioavailability[1][4].

By Route of Administration

Traditional oral formulations dominate the market, but new routes such as continuous subcutaneous infusion (e.g., ND0612) and gastric-retentive dosage forms (e.g., Accordion Pill™) are gaining traction. These new formulations aim to provide consistent medication levels and reduce motor fluctuations[2][5].

By Distribution Channels

Healthcare providers are the major customers in the levodopa market, highlighting the importance of prescription-based sales channels[1].

By Region

North America dominated the global levodopa market in 2022, driven by a high prevalence of Parkinson's disease, advanced healthcare infrastructure, and robust pharmaceutical regulatory frameworks. The Asia-Pacific region is projected to offer significant business opportunities in the future[1][4].

Competitive Scenario

The levodopa market is highly competitive, with key players including Novartis AG, Merck & Co. Inc., Eli Lilly & Company, Bristol-Myers Squibb Co., Teva Pharmaceutical Industries Ltd., Impax Laboratories Inc., Pfizer Inc., UCB SA, Sun Pharmaceutical Industries Ltd., and Mylan NV. These companies are investing heavily in research and development to enhance treatment efficacy and accessibility[1][4].

Innovative Formulations

Accordion Pill™

The Accordion Pill™ of carbidopa/levodopa is a gastric-retentive dosage form designed to provide prolonged absorption of levodopa, resulting in stable plasma levels and reduced motor fluctuations. Phase II studies have shown significant improvements in "off" time and symptom control without increasing dyskinesia[2].

ND0612

ND0612 is a liquid levodopa/carbidopa formulation administered continuously under the skin. Phase III trial results indicate that ND0612 provides nearly one and three-quarters hours more "on" time per day without significant symptoms, offering a promising treatment option for patients with advanced Parkinson’s disease[5].

Financial Trajectory

The financial trajectory of the levodopa market is positive, driven by increasing demand and technological advancements. Here are some key financial highlights:

• Market Size: The global levodopa market is expected to grow from $1.7 billion in 2022 to $2.9 billion by 2032[1][4].
• Growth Rate: The market is projected to grow at a CAGR of 6.1% from 2023 to 2032[1][4].
• Revenue Generation: The North America levodopa market generated the highest revenue in 2022, driven by a high prevalence of Parkinson's disease and advanced healthcare infrastructure[1][4].

Key Trends and Opportunities

Advancements in Drug Delivery Systems

Innovations in drug delivery systems are a key trend, enhancing the efficacy and convenience of levodopa therapy. These advancements include extended-release formulations, gastric-retentive dosage forms, and continuous infusion systems[2][5].

Focus on Personalized Medicine

There is an increasing focus on personalized medicine, with research aimed at tailoring treatments to individual patient needs. This includes the use of COMT inhibitors to enhance levodopa bioavailability and prolong its elimination[3].

Emerging Markets

The Asia-Pacific region is expected to provide significant business opportunities for the levodopa market in the future, driven by growing healthcare expenditure and an increasing prevalence of Parkinson's disease[1][4].

Challenges and Limitations

Long-term Use Complications

Long-term use of levodopa can lead to complications such as dyskinesias, which are involuntary movements. Managing these side effects is a challenge in the long-term treatment of Parkinson's disease[1].

Motor Fluctuations

Motor fluctuations, which can occur after years of levodopa treatment, remain a significant challenge. New formulations aim to address this issue by providing stable plasma levels of levodopa[2][5].

Key Takeaways

• The global levodopa market is driven by the rising prevalence of Parkinson's disease and advancements in drug delivery systems.
• North America dominates the market due to its robust healthcare infrastructure and high prevalence of Parkinson's disease.
• Innovative formulations such as the Accordion Pill™ and ND0612 are enhancing treatment efficacy and patient outcomes.
• The market is expected to grow at a CAGR of 6.1% from 2023 to 2032, reaching $2.9 billion by 2032.

Frequently Asked Questions

Q: What is the primary use of carbidopa/levodopa in medical treatment? A: Carbidopa/levodopa is primarily used to manage symptoms of Parkinson's disease by replenishing dopamine levels in the brain.

Q: What are the key drivers of the levodopa market? A: The key drivers include the rising prevalence of Parkinson's disease, advancements in drug delivery systems, and robust healthcare infrastructure in regions like North America.

Q: Which region dominates the global levodopa market? A: North America dominates the global levodopa market due to its high prevalence of Parkinson's disease and advanced healthcare infrastructure.

Q: What are some innovative formulations in the levodopa market? A: Innovative formulations include the Accordion Pill™, a gastric-retentive dosage form, and ND0612, a liquid levodopa/carbidopa formulation administered continuously under the skin.

Q: What is the projected growth rate of the levodopa market from 2023 to 2032? A: The levodopa market is projected to grow at a CAGR of 6.1% from 2023 to 2032.

Cited Sources

1. Allied Market Research - Levodopa Market Size, Growth Analysis | Forecast - 2032
2. Michael J. Fox Foundation - Six-month Oral Toxicity Study of the Accordion Pill™ of Carbidopa/Levodopa
3. SkyQuestT - Parkinson's Disease Drug Market Size, Share, Trends & Forecast
4. Research Dive - Levodopa Market Size, Share, Statistics | Forecast - 2032
5. Michael J. Fox Foundation - New Parkinson's Drug Formulation Shows Positive Phase III Trial Results