CARBIDOPA - Generic Drug Details

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

Carbidopa is the generic ingredient in eighteen branded drugs marketed by Alvogen, Ani Pharms, Aurobindo Pharma, Beximco Pharms Usa, Edenbridge Pharms, Novel Labs Inc, Zydus Pharms, Aton, Norvium Bioscience, Rising, Sun Pharm, Wockhardt Ltd, Orion Pharma, Impax, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Ucb Inc, Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, Avion Pharms, and Organon, and is included in fifty NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for carbidopa. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CARBIDOPA

US Patents:	22
Tradenames:	18
Applicants:	35
NDAs:	50
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	210
Patent Applications:	5,659
Drug Prices:	Drug price trends for CARBIDOPA
What excipients (inactive ingredients) are in CARBIDOPA?	CARBIDOPA excipients list
DailyMed Link:	CARBIDOPA at DailyMed

See drug prices for CARBIDOPA

Recent Clinical Trials for CARBIDOPA

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	Phase 1
Impax Laboratories, LLC	Phase 1
ISS, Inc.	Phase 2

See all CARBIDOPA clinical trials

Generic filers with tentative approvals for CARBIDOPA

Applicant	Application No.	Strength	Dosage Form
		61.25MG;245MG	CAPSULE, EXTENDED RELEASE;ORAL
		48.75MG;195MG	CAPSULE, EXTENDED RELEASE;ORAL
		36.25MG;145MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for CARBIDOPA

Antiparkinson Agents

Aromatic Amino Acid Decarboxylase Inhibitors

Dopamine Agents

US Patents and Regulatory Information for CARBIDOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novel Labs Inc	CARBIDOPA	carbidopa	TABLET;ORAL	204763-001	Oct 20, 2017	AB	RX	No	No
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No	9,089,607		Y
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	AB	RX	Yes	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	10,098,845		Y
Actavis Elizabeth	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	074260-003	Sep 3, 1993	AB	RX	No	Yes

Expired US Patents for CARBIDOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,462,536
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,781,415
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,830,827

CARBIDOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbidopa in the Treatment of Parkinson's Disease

Introduction

Carbidopa, often combined with levodopa, is a cornerstone in the treatment of Parkinson's disease (PD), a neurodegenerative disorder characterized by motor symptoms such as tremors, rigidity, and bradykinesia. The market for carbidopa and its combinations is robust and growing, driven by several key factors.

Current Market Size and Forecast

The global Parkinson's disease market, which includes carbidopa and levodopa formulations, was valued at USD 3.6 billion in 2023 and is projected to reach USD 11.66 billion by 2034, growing at a compound annual growth rate (CAGR) of over 12%[1][3][4].

Dominance of Carbidopa-Levodopa Segment

The carbidopa-levodopa segment dominates the Parkinson's disease treatment market, accounting for more than 25% of the market share in 2021. This dominance is due to the high prescription and usage rates of carbidopa-levodopa, which is effective in managing motor symptoms and has been a long-standing therapy for PD[1][4].

Regional Market Dynamics

North America

North America is anticipated to have the highest revenue share during the forecast period, driven by advanced healthcare infrastructure, high prevalence of Parkinson's disease, strong research and development activities, and greater access to novel therapies and treatment options[1].

Asia Pacific

The Asia Pacific region is expected to grow at the fastest CAGR, driven by a large population base, increasing awareness about neurological disorders, rising healthcare expenditure, improving healthcare infrastructure, and a growing emphasis on research and development[1].

Drug Class and Formulations

Levodopa/Carbidopa Combinations

Levodopa combined with carbidopa remains the gold standard for PD treatment. This combination is effective in managing motor symptoms and is widely prescribed. Extended-release formulations like IPX066 (carbidopa/levodopa extended release) have also shown promise in reducing motor fluctuations and improving the quality of life for patients[2][3].

Generic and Brand Formulations

Generic formulations of carbidopa-levodopa are widely available and account for a significant portion of the market. However, there can be up to a 20% difference in treatment effect between generic and brand-name versions, which can be a concern for patients with sensitive responses to medication dosages[2].

Distribution Channels

Retail Pharmacy

Retail pharmacies, such as Walgreens and Walmart, play a crucial role in the distribution of carbidopa-levodopa medications. The ease of availability and accessibility of these drugs in retail chains contribute significantly to the market growth[4].

Online Pharmacy

The online pharmacy segment is expected to witness significant growth due to the comfort, flexibility, and convenience it offers. Online platforms provide various discounts and benefits, further boosting the demand for online pharmacies[4].

Pipeline and Future Trends

Novel Delivery Systems

Advancements in delivery systems, such as subcutaneous pumps for continuous levodopa delivery (e.g., AbbVie’s ABBV-951 and Mitsubishi’s ND-0612), are expected to revolutionize the treatment landscape. These systems aim to reduce motor fluctuations and provide a more consistent therapeutic effect[3].

Biologics and Disease-Modifying Therapies

The pipeline includes biologics like Roche’s PRX-002 (prasinezumab), which targets the α-synuclein protein to potentially halt disease progression. Such disease-modifying therapies are expected to significantly impact the market and patient outcomes[3].

Challenges and Considerations

Medication Shortages and Consistency

Medication shortages, such as the Sinemet shortage, can cause significant disruptions for patients. Maintaining consistency in medication supply and dosage is crucial, and patients are advised to communicate closely with their pharmacists and healthcare providers to manage these issues effectively[2].

Insurance and Access

The "eight Sinemet limit" imposed by some insurance companies and pharmacies can restrict access to necessary medications. Patients and healthcare providers must navigate these limitations through appeals and support from organizations like the Parkinson's Foundation[2].

Key Players

Major pharmaceutical companies such as Novartis AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., GlaxoSmithKline plc (GSK), AbbVie, Inc., and Amneal Pharmaceuticals LLC are key players in the carbidopa-levodopa market. These companies are driving innovation and accessibility through various product offerings and patient support programs[4].

Patient Support and Access Programs

Companies like Amneal Pharmaceuticals offer patient support programs, including savings, co-pay support, and other resources to help manage the treatment journey. These programs enhance patient access to essential medications like RYTARY (carbidopa-levodopa extended-release capsules)[5].

Financial Trajectory

The financial trajectory for carbidopa and its combinations is positive, driven by a strong pipeline of novel therapies, increasing prevalence of Parkinson's disease, and advancements in delivery systems. The market is expected to nearly triple by 2029, with significant contributions from new pipeline products addressing key unmet needs[3][4].

Key Takeaways

• The carbidopa-levodopa segment dominates the Parkinson's disease treatment market.
• North America and Asia Pacific are key regions driving market growth.
• Novel delivery systems and biologics are set to revolutionize PD treatment.
• Patient support programs are crucial for enhancing access to medications.
• The market is expected to reach USD 11.66 billion by 2034.

FAQs

What is the current market size of the Parkinson's disease treatment market?

The global Parkinson's disease treatment market was valued at USD 3.6 billion in 2023[1].

Why is the carbidopa-levodopa segment dominant in the PD treatment market?

The carbidopa-levodopa segment is dominant due to its effectiveness in managing motor symptoms and its long-standing status as a cornerstone therapy in PD treatment[1][4].

What are the key regions driving the growth of the PD treatment market?

North America and Asia Pacific are the key regions driving market growth, with North America having the highest revenue share and Asia Pacific growing at the fastest CAGR[1].

What are the novel delivery systems being developed for PD treatment?

Novel delivery systems include subcutaneous pumps for continuous levodopa delivery, such as AbbVie’s ABBV-951 and Mitsubishi’s ND-0612[3].

How do patient support programs impact access to carbidopa-levodopa medications?

Patient support programs, such as those offered by Amneal Pharmaceuticals, enhance patient access to essential medications through savings, co-pay support, and other resources[5].

Sources

1. GlobeNewswire: $11.66 Billion Parkinson's Disease Market Forecast, 2030 by Drug Class, Medical Devices, Devices, Route of Administration, Distribution Channel, and Region.
2. Parkinson's Foundation: What should I do if there is a Sinemet (Carbidopa/Levodopa) shortage?
3. European Pharmaceutical Review: Parkinson’s disease market sales to reach $11.5 billion in 2029.
4. Grand View Research: Parkinson's Disease Treatment Market Size Report, 2030.
5. Rytary: Patient Savings and Co-Pay Support.