Levodopa - PharmaKB

Sinemet, Stalevo(levodopa)

Carbidopa / / Levodopa, Carbidopa / Levodopa, Corbilta, Dhivy, Duopa, Inbrija, Levodopa/Carbidopa/Entacapone, Numient, Rytary, Sinemet, Stalevo (levodopa) is a small molecule pharmaceutical. Levodopa was first approved as Sinemet on 1982-01-01. It is used to treat parkinson disease in the USA. It has been approved in Europe to treat parkinson disease. It is known to target G-protein coupled receptor 143.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422

Trade Name

FDA

EMA

Inbrija (discontinued: Bendopa, Dopar, Larodopa)

Combinations

Dhivy, Duopa, Rytary, Sinemet, Stalevo (generic drugs available since 1992-08-28, discontinued: Carbilev, Parcopa)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Carbidopa

Entacapone

Levodopa

Tradename	Company	Number	Date	Products
STALEVO 75	Orion Pharma	N-021485 RX	2008-08-29	1 products, RLD
STALEVO 125	Orion Pharma	N-021485 RX	2008-08-29	1 products, RLD
STALEVO 200	Orion Pharma	N-021485 RX	2007-08-02	1 products, RLD, RS
STALEVO 50	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD, RS
STALEVO 100	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD
STALEVO 150	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD

Carbidopa

Levodopa

Tradename	Company	Number	Date	Products
DUOPA	AbbVie	N-203952 RX	2015-01-09	1 products, RLD, RS
DHIVY	Avion Pharmaceuticals	N-214869 RX	2021-11-12	1 products, RLD, RS
RYTARY	Impax Laboratories	N-203312 RX	2015-01-07	4 products, RLD, RS
SINEMET	Organon	N-017555 RX	1982-01-01	3 products, RLD

Show 1 discontinued

Levodopa

Tradename	Company	Number	Date	Products
INBRIJA	Acorda Therapeutics	N-209184 RX	2018-12-21	1 products, RLD, RS

Show 3 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
carbidopa and levodopa	ANDA	2024-01-22
carbidopa, levodopa and entacapone	ANDA	2022-02-01
carbidopa, levodopa, and entacapone	NDA authorized generic	2016-02-01
carbidopa-levodopa	ANDA	2023-04-08
dhivy	New Drug Application	2024-01-31
duopa	New Drug Application	2022-03-04
parcopa		2007-11-05
rytary	New Drug Application	2022-12-21
sinemet	New Drug Application	2022-06-01
stalevo	New Drug Application	2021-07-30

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
parkinson disease	EFO_0002508	D010300	G20

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Carbidopa / Levodopa, Dhivy, Avion Pharms
11033521	2039-03-28	DP	U-219, U-3304, U-3305
11439613	2039-03-28		U-3557
Levodopa, Inbrija, Acorda
8545878	2032-11-16	DP
8685442	2032-11-16	DP
8945612	2032-11-16	DP
9393210	2032-11-16	DP
RE43711	2029-02-03		U-2484
7182961	2024-02-22	DP
8404276	2023-03-19		U-2484
8586093	2023-03-19		U-2484
9155699	2023-03-19	DP
Carbidopa / Levodopa, Rytary, Impax Labs Inc
8377474	2028-12-26	DP	U-219, U-1645
8454998	2028-12-26	DP	U-219, U-1645, U-1646, U-1647, U-1649
8557283	2028-12-26	DP	U-219, U-1645
9089607	2028-12-26	DP	U-1645, U-1720
9089608	2028-12-26	DP
9463246	2028-12-26	DP	U-219
9533046	2028-12-26	DP	U-219
9901640	2028-12-26	DP	U-219

ATC Codes

N: Nervous system drugs

— N04: Anti-parkinson drugs

— N04B: Dopaminergic agents

— N04BA: Dopa and dopa derivatives

— N04BA01: Levodopa

— N04BA02: Levodopa and decarboxylase inhibitor

— N04BA03: Levodopa, decarboxylase inhibitor and comt inhibitor

HCPCS

Code	Description
J7340	Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100 ml

Clinical

Clinical Trials

569 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Parkinson disease	D010300	EFO_0002508	G20	71	130	108	47	102	429
Dyskinesias	D020820	HP_0002310	G24	2	20	10	1	2	31
Healthy volunteers/patients	—	—	—	10	—	—	4	1	15
Depression	D003863	—	F33.9	1	—	—	5	2	8
Stroke	D020521	EFO_0000712	I63.9	1	2	2	3	2	8
Back pain	D001416	HP_0003418	M54	—	2	—	1	—	3
Neurologic gait disorders	D020233	HP_0003376	R26.1	—	1	—	1	1	3
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	1	—	2	—	3
Anhedonia	D059445	—	R45.84	—	—	—	2	—	2
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	—	1	—	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug-induced dyskinesia	D004409	EFO_1000904	—	—	6	3	—	2	9
Cocaine-related disorders	D019970	—	F14	1	6	1	—	1	8
Spinal cord injuries	D013119	EFO_1001919	—	3	2	1	—	—	4
Angelman syndrome	D017204	Orphanet_72	Q93.51	1	1	1	—	1	3
Restless legs syndrome	D012148	EFO_0004270	G25.81	—	—	2	—	1	3
Orthostatic hypotension	D007024	—	I95.1	1	1	1	—	—	2
Amblyopia	D000550	HP_0000646	H53.00	—	1	1	—	—	2
Stroke rehabilitation	D000071939	—	—	—	—	1	—	—	1
Ischemic stroke	D000083242	—	—	—	—	1	—	—	1
Broca aphasia	D001039	—	—	—	1	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Movement disorders	D009069	HP_0100022	—	3	8	—	—	3	13
Parkinsonian disorders	D020734	HP_0001300	G20.C	1	4	—	—	2	7
Macular degeneration	D008268	EFO_0001365	H35.30	—	5	—	—	1	6
Central nervous system diseases	D002493	HP_0002011	G96.9	1	3	—	—	—	4
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	1	2	—	—	1	4
Brain diseases	D001927	HP_0001298	G93.40	1	2	—	—	—	3
Glioblastoma	D005909	EFO_0000515	—	—	2	—	—	—	2
Nervous system diseases	D009422	—	G00-G99	1	1	—	—	—	2
Acute pain	D059787	—	R52	—	2	—	—	—	2
Albinism	D000417	HP_0001022	E70.3	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pure autonomic failure	D054970	—	—	1	—	—	—	2	3
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Traumatic brain injuries	D000070642	—	S06	1	—	—	—	—	1
Consciousness disorders	D003244	—	—	1	—	—	—	—	1
Mothers	D009035	—	—	1	—	—	—	—	1
Amyotrophic lateral sclerosis	D000690	HP_0007354	G12.21	1	—	—	—	—	1
Motor neuron disease	D016472	EFO_0003782	G12.2	1	—	—	—	—	1
Placebos	D010919	—	—	1	—	—	—	—	1
Amyloidosis	D000686	EFO_1001875	E85	1	—	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple system atrophy	D019578	—	—	—	—	—	—	5	5
Progressive supranuclear palsy	D013494	EFO_0002512	G23.1	—	—	—	—	2	2
Diet therapy	D004035	—	—	—	—	—	—	2	2
Huntington disease	D006816	Orphanet_399	G10	—	—	—	—	1	1
Corticobasal degeneration	D000088282	—	G31.85	—	—	—	—	1	1
Sleep wake disorders	D012893	—	G47	—	—	—	—	1	1
Glucose intolerance	D018149	HP_0000833	R73.03	—	—	—	—	1	1
Delirium	D003693	—	R41.0	—	—	—	—	1	1
Deep brain stimulation	D046690	—	—	—	—	—	—	1	1
Pain threshold	D017288	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Levodopa
INN	levodopa
Description	L-dopa is an optically active form of dopa having L-configuration. Used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease It has a role as a prodrug, a hapten, a neurotoxin, an antiparkinson drug, a dopaminergic agent, an antidyskinesia agent, an allelochemical, a plant growth retardant, a human metabolite, a mouse metabolite and a plant metabolite. It is a dopa, a L-tyrosine derivative and a non-proteinogenic L-alpha-amino acid. It is a conjugate acid of a L-dopa(1-). It is an enantiomer of a D-dopa. It is a tautomer of a L-dopa zwitterion.
Classification	Small molecule
Drug class	dopamine receptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O