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Last Updated: December 22, 2024

CARBIDOPA AND LEVODOPA Drug Patent Profile


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Which patents cover Carbidopa And Levodopa, and when can generic versions of Carbidopa And Levodopa launch?

Carbidopa And Levodopa is a drug marketed by Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Rising, Sun Pharm, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, and Zydus Pharms. and is included in twenty-eight NDAs.

The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Carbidopa And Levodopa

A generic version of CARBIDOPA AND LEVODOPA was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.

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Drug patent expirations by year for CARBIDOPA AND LEVODOPA
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Recent Clinical Trials for CARBIDOPA AND LEVODOPA

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

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
Bronx VA Medical CenterPhase 1
VistaGen Therapeutics, Inc.Phase 2

See all CARBIDOPA AND LEVODOPA clinical trials

Pharmacology for CARBIDOPA AND LEVODOPA

US Patents and Regulatory Information for CARBIDOPA AND LEVODOPA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073607-001 Aug 28, 1992 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073587-003 Jun 29, 1995 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 214092-002 May 7, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 215999-001 Apr 4, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rubicon CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 216505-001 Sep 21, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 214092-003 May 7, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CARBIDOPA AND 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

CARBIDOPA AND LEVODOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbidopa and Levodopa

Introduction to Carbidopa and Levodopa

Carbidopa and levodopa, often combined as carbidopa/levodopa, are cornerstone therapies 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 conversion of levodopa to dopamine outside the brain, enhancing the effectiveness of levodopa and reducing side effects.

Market Size and Growth

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

Drivers of Market Growth

Rising Prevalence of Parkinson's Disease

The increasing prevalence of Parkinson's disease, driven by an aging population and changing lifestyle patterns, is a significant driver of the carbidopa/levodopa market. As people live longer, the incidence of Parkinson's disease rises, creating a higher demand for effective treatments like carbidopa/levodopa[1].

Advanced Healthcare Infrastructure

In regions like North America, the robust healthcare infrastructure and advanced medical research facilities foster innovation in Parkinson's disease management. This includes the development of novel levodopa formulations and treatment approaches, which contribute to market growth[1].

Government Funding and Research

Government funding for research into Parkinson's disease and related treatments also drives the market. This funding supports the development of new therapies and improves existing ones, such as carbidopa/levodopa combinations[5].

Market Segmentation

By Form

The tablets segment of the carbidopa/levodopa market acquired the maximum share in 2022. However, innovative formulations like the Accordion Pill, a gastric-retentive dosage form, are gaining traction due to their ability to provide stable and prolonged absorption of levodopa[1][4].

By Route of Administration

Traditional oral administration remains dominant, but advanced device-aided therapies such as deep brain stimulation (DBS) and levodopa-carbidopa intestinal gel (LCIG) are becoming more popular. These alternatives offer better symptom control and reduced side effects for some patients[2].

By Distribution Channels

Healthcare providers are the major customers in the carbidopa/levodopa market. Distribution channels include hospitals, clinics, and retail pharmacies, with online pharmacies also emerging as a significant channel[5].

Geographical Analysis

North America

North America dominated the global levodopa market in 2022, driven by a high prevalence of Parkinson's disease, an aging population, and supportive healthcare policies. The presence of leading pharmaceutical companies and research institutions in this region further contributes to market growth[1].

Asia-Pacific

The Asia-Pacific region is projected to provide more business opportunities for the levodopa market in the future. This is due to the growing healthcare expenditure, increasing awareness of Parkinson's disease, and the expanding population in this region[1].

Key Market Players

Major players in the carbidopa/levodopa market include 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].

Technological Advancements

Innovative Formulations

Advancements in drug delivery systems, such as the Accordion Pill, are significant. This pill provides a prolonged and stable absorption of levodopa, reducing "off" time and the number of daily doses required. Such innovations are expected to shape treatment efficacy and patient outcomes positively[4].

Combination Therapies

The focus on combination therapies, including MAO-B inhibitors and COMT inhibitors, is growing. These combinations are predicted to grow at the fastest CAGR during the forecast period due to their efficacy in adjunctive therapy and the introduction of novel formulations and delivery methods[3].

Challenges and Restraints

Side Effects and Adverse Events

Long-term use of carbidopa/levodopa can lead to complications such as dyskinesias. Patients often experience side effects like fatigue, drowsiness, constipation, and bowel issues, which can impact their quality of life. High pill burden and difficulties with medication adherence are also significant challenges[2].

Alternative Treatments

The availability of alternative treatments, including advanced medical devices like DBS and LCIG, can restrain the growth of the carbidopa/levodopa market. However, these alternatives often complement rather than replace traditional carbidopa/levodopa therapy[5].

Opportunities

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer significant opportunities for growth. Increasing healthcare expenditure and growing awareness of Parkinson's disease in these regions are expected to drive demand for carbidopa/levodopa[1].

Patent Expiry and Strong Pipeline

The patent expiry of branded drugs and a strong pipeline of new treatments provide opportunities for generic and innovative formulations to enter the market. This can lead to increased competition and potentially lower costs for patients[5].

Financial Trajectory

The financial trajectory of the carbidopa/levodopa market is positive, driven by the increasing demand for effective Parkinson's disease treatments. Here are some key financial highlights:

  • Market Size: The global levodopa market is projected to reach $2.9 billion by 2032[1].
  • Growth Rate: The market is expected to grow at a CAGR of 6.1% from 2023 to 2032[1].
  • Revenue Segmentation: The carbidopa/levodopa segment accounted for the highest revenue in the global Parkinson's disease market in 2023, highlighting its effectiveness and long-standing status as a cornerstone therapy[3].
"The carbidopa/levodopa segment accounted for the highest revenue-grossing segment in the global Parkinson's disease market in 2023 owing to its effectiveness in managing motor symptoms and its long-standing status as a cornerstone therapy in Parkinson's disease treatment."[3]

Key Takeaways

  • The carbidopa/levodopa market is driven by the rising prevalence of Parkinson's disease and an aging population.
  • Advanced healthcare infrastructure and government funding for research are significant drivers.
  • Innovative formulations and combination therapies are shaping the market.
  • Emerging markets and patent expiry of branded drugs offer future opportunities.
  • The market is expected to grow at a CAGR of 6.1% from 2023 to 2032.

Frequently Asked Questions (FAQs)

1. What is the primary use of carbidopa and levodopa in medical treatment?

Carbidopa and levodopa are primarily used to manage symptoms of Parkinson's disease by replenishing dopamine levels in the brain.

2. What are the key drivers of the carbidopa/levodopa market?

The key drivers include the rising prevalence of Parkinson's disease, an aging population, advanced healthcare infrastructure, and government funding for research.

3. Which region dominates the global levodopa market?

North America dominates the global levodopa market due to its robust healthcare infrastructure and high prevalence of Parkinson's disease.

4. What are some of the innovative formulations in the carbidopa/levodopa market?

Innovative formulations include the Accordion Pill, a gastric-retentive dosage form designed to provide stable and prolonged absorption of levodopa.

5. What are the potential challenges and restraints in the carbidopa/levodopa market?

Challenges include side effects and adverse events, high pill burden, and the availability of alternative treatments.

Sources:

  1. Allied Market Research. Levodopa Market Size, Growth Analysis | Forecast - 2032.
  2. Canada's Drug Agency. Foslevodopa-Foscarbidopa (Vyalev).
  3. GlobeNewswire. $11.66 Billion Parkinson's Disease Market Forecast, 2030 by Drug Class, Medical Devices, Devices, Route of Administration, Distribution Channel, and Region.
  4. The Michael J. Fox Foundation. Six-month Oral Toxicity Study of the Accordion Pill™ of Carbidopa/Levodopa.
  5. MarketsandMarkets. Parkinson's Disease Treatment Market Revenue Forecast.

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