Sinemet, Stalevo(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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Novartis Pharmaceuticals

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	2023-04-18
dhivy	New Drug Application	2021-11-29
duopa	New Drug Application	2020-05-21
inbrija	New Drug Application	2021-01-05
rytary	New Drug Application	2019-12-19
sinemet	New Drug Application	2021-06-01
stalevo	New Drug Application	2020-05-01

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

249 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	35	50	34	27	18	155
Healthy volunteers/patients	—			9	—	—	4	1	14
Stroke	D020521	EFO_0000712	I63.9	1	2	2	3	1	7
Depression	D003863		F33.9	—	—	—	4	1	5
Dyskinesias	D020820		G24	—	2	1	1	1	5
Back pain	D001416	HP_0003418	M54	—	2	—	1	—	3
Cognitive dysfunction	D060825		G31.84	—	1	—	2	—	3
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	—	1	—	2
Neurologic gait disorders	D020233		R26.1	—	1	—	1	—	2
Major depressive disorder	D003865	EFO_0003761	F22	—	—	—	2	—	2

Show 12 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cocaine-related disorders	D019970		F14	1	6	1	—	1	8
Spinal cord injuries	D013119	EFO_1001919		2	2	1	—	—	3
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		H53.00	—	1	1	—	—	2
Stroke rehabilitation	D000071939			—	—	1	—	—	1
Ischemic stroke	D000083242			—	—	1	—	—	1
Broca aphasia	D001039			—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Macular degeneration	D008268	EFO_0001365	H35.30	—	5	—	—	—	5
Movement disorders	D009069	EFO_0004280	G25	—	2	—	—	1	3
Central nervous system diseases	D002493	HP_0002011	G96.9	—	2	—	—	—	2
Brain diseases	D001927	HP_0001298	G93.40	—	2	—	—	—	2
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	—	2	—	—	—	2
Acute pain	D059787		R52	—	2	—	—	—	2
Albinism	D000417		E70.3	—	2	—	—	—	2
Schizophrenia	D012559	EFO_0000692	F20	—	1	—	—	1	2
Opioid-related disorders	D009293	EFO_0005611	F11	—	1	—	—	1	2
Parkinsonian disorders	D020734	HP_0001300		—	1	—	—	1	2

Show 9 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pure autonomic failure	D054970			1	—	—	—	—	1
Pharmacokinetics	D010599			1	—	—	—	—	1
Traumatic brain injuries	D000070642		S06	1	—	—	—	—	1
Consciousness disorders	D003244			1	—	—	—	—	1
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	1	—	—	—	—	1
Motor neuron disease	D016472	EFO_0003782	G12.2	1	—	—	—	—	1
Placebos	D010919			1	—	—	—	—	1
Smoking	D012907	EFO_0003768	F17	1	—	—	—	—	1
Asthma	D001249	EFO_0000270	J45	1	—	—	—	—	1
Tourette syndrome	D005879	EFO_0004895	F95.2	1	—	—	—	—	1

Show 2 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple system atrophy	D019578			—	—	—	—	2	2
Sleep wake disorders	D012893		G47	—	—	—	—	1	1
Pain threshold	D017288			—	—	—	—	1	1
Alcoholism	D000437	EFO_0003829	F10.1	—	—	—	—	1	1
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	—	1	1
Essential tremor	D020329	EFO_0003108	G25.0	—	—	—	—	1	1

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

Identifiers

PDB	6ON3
CAS-ID	59-92-7
RxCUI	6375
ChEMBL ID	CHEMBL1009
ChEBI ID	15765
PubChem CID	6047
DrugBank	DB01235
UNII ID	46627O600J (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

GPR143

Organism

Homo sapiens

Gene name

GPR143

Gene synonyms

OA1

NCBI Gene ID

4935

Protein name

G-protein coupled receptor 143

Protein synonyms

ocular albinism 1, Ocular albinism type 1 protein

Uniprot ID

Q6NTI7

Mouse ortholog

Gpr143 (18241)

G-protein coupled receptor 143 (P70259)

Variants

Clinical Variant

No data

Financial

Sinemet - Organon

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Rytary - Amneal Pharmaceuticals

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Inbrija - Acorda Therapeutics

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Trends

PubMed Central

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Additional graphs summarizing 27,884 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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577 adverse events reported

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