NDAORALTABLETPriority Review
Approved
May 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
SINEMET (carbidopa and levodopa) by Merck & Co. is dopa decarboxylase inhibitors [moa]. First approved in 1975.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SINEMET is a combination of carbidopa and levodopa, a foundational Parkinson's disease treatment approved in 1975 that works by inhibiting DOPA decarboxylase to increase dopamine availability in the brain. Levodopa is converted to dopamine to replace deficient neurotransmitter levels in Parkinson's patients, while carbidopa prevents premature conversion in the periphery. This oral tablet formulation remains a first-line standard of care for motor symptom management.
LOE Approaching
As LOE approaches, commercial teams are shifting focus to lifecycle extension strategies, specialty care partnerships, and managed care retention rather than growth-oriented expansion.
Mechanism of Action
DOPA Decarboxylase Inhibitors
Pharmacologic Class:
Aromatic Amino Acid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)
Started Apr 2015
6 enrolled
Parkinson's Disease
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
Started Mar 2009
52 enrolled
Parkinson Disease
A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects
Started Jun 2007
20 enrolled
Parkinson's Disease
A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease
Started Jun 2005
Parkinson's Disease
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
Started Jul 2004
220 enrolled
Parkinson Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.