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Levodopa - Generic Drug Details

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

Levodopa is the generic ingredient in four branded drugs marketed by Valeant Pharm Intl, Shire, Roche, and Acorda, and is included in four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levodopa has one hundred and forty-one patent family members in twenty-six countries.

There are eighteen drug master file entries for levodopa. One supplier is listed for this compound.

Summary for levodopa

International Patents:	141
US Patents:	18
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	18
Suppliers / Packagers:	1
Bulk Api Vendors:	106
Clinical Trials:	364
Patent Applications:	6,918
Formulation / Manufacturing:	see details
DailyMed Link:	levodopa at DailyMed

Pharmacology for levodopa

Drug Class

Aromatic Amino Acid

Medical Subject Heading (MeSH) Categories for levodopa

Antiparkinson Agents

Dopamine Agents

Synonyms for levodopa

.beta.-(3, 4-Dihydroxyphenyl)alanine

.beta.-(3,4-Dihydroxyphenyl)-L-alanine

.beta.-(3,4-Dihydroxyphenyl)alanine

(-)-(3,4-Dihydroxyphenyl)alanine

(-)-3-(3,4-Dihydroxyphenyl)-L-alanine

(-)-Dopa

(2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoate

(2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid

(2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acidL-dopa

(S)-2-Amino-3-(3,4-dihydroxy-phenyl)-propionic acid

(S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid

(S)-3,4-dihydroxyphenylalanine

13173-EP2269989A1

13173-EP2277876A1

13173-EP2277882A1

13173-EP2281559A1

13173-EP2281815A1

13173-EP2292614A1

13173-EP2295412A1

13173-EP2295413A1

13173-EP2295439A1

13173-EP2298731A1

13173-EP2301933A1

13173-EP2301934A1

13173-EP2305633A1

13173-EP2305640A2

13173-EP2308867A2

13173-EP2308870A2

13173-EP2311827A1

13173-EP2311837A1

13173-EP2314571A2

13173-EP2316470A2

13173-EP2316834A1

1E83F927-C221-46AA-B90A-81B33C5F3868

21660-EP2272832A1

21660-EP2275420A1

21660-EP2281559A1

21660-EP2301934A1

21660-EP2314571A2

21920-EP2295410A1

21920-EP2301939A1

21920-EP2314571A2

23734-74-9

25525-15-9

3-(3,4-Dihydroxyphenyl)-L-alanine

3-(3,4-Dihydroxyphenyl)-L-alanine, 99%

3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-Hydroxytyrosine; L-DOPA; Levodopa

3-Hydroxy-L-tyrosine

3, 4-Dihydroxy-L-phenylalanine

3, 4-Dihydroxyphenylalanine

3,4-dihydroxy-L-phenylalanine

3,4-Dihydroxy-L-phenylalanine, >=98% (TLC)

3,4-Dihydroxy-L-phenylalanine, certified reference material, TraceCERT(R)

3,4-Dihydroxy-L-phenylalanine, Vetec(TM) reagent grade, 98%

3,4-Dihydroxyphenyl-L-alanine

3,4-Dihydroxyphenylalanine

3,4-Dihydroxyphenylalanine (VAN)

34241-25-3

46627O600J

587-45-1

59-92-7

59L927

72572-99-7

72573-00-3

88250-23-1

90638-38-3

AB00052418_08

AB00052418_09

AB00052418-06

AB00052418-07

AB0013279

AB1009504

AC-8432

AC1L1LOR

AC1Q4U7F

AJ-24154

AK187821

AKOS010396267

Alanine, 3-(3, 4-dihydroxyphenyl)-, (-)-

Alanine, 3-(3,4-dihydroxyphenyl)-

Alanine, 3-(3,4-dihydroxyphenyl)-, (-)-

alanine, 3-(3,4-dihydroxyphenyl)-, L-

Alanine,4-dihydroxyphenyl)-

Alanine,4-dihydroxyphenyl)-, (-)-

Alanine,4-dihydroxyphenyl)-, L-

AM82124

AN-1108

ANW-33396

AS-13287

b-(3,4-Dihydroxyphenyl)-a-L-alanine

b-(3,4-Dihydroxyphenyl)-L-alanine

b-(3,4-Dihydroxyphenyl)alanine

BC677906

BDBM50130192

BDBM60928

Bendopa

beta-(3,4-Dihydroxyphenyl)-alpha-alanine

beta-(3,4-Dihydroxyphenyl)-alpha-L-alanine

beta-(3,4-Dihydroxyphenyl)-L-alanine

beta-(3,4-Dihydroxyphenyl)alanine

BIDD:GT0158

Biodopa

bmse000322

BP-12850

BPBio1_000059

Brocadopa

BSPBio_000053

BSPBio_002354

C00355

C9H11NO4

CAS-59-92-7

CCG-39571

CCRIS 3766

Cerepap

CHEBI:15765

CHEMBL1009

Cidandopa

component of Sinemet

CS-1945

CTK1H2187

CVT-301

D 9628

D00059

D0600

D9628

DB01235

Deadopa

Dihydroxy-L-phenylalanine

dihydroxyphenylalanine

DivK1c_000452

Dopa

Dopaflex

Dopaidan

Dopal-fher

Dopalina

Dopar

Dopar (TN)

Doparkine

Doparl

Dopasol

Dopaston

Dopaston SE

Dopastone

Dopastral

Dopicar

Doprin

DSSTox_CID_3209

DSSTox_GSID_23209

DSSTox_RID_76926

DTXSID9023209

EINECS 200-445-2

Eldopal

Eldopar

Eldopatec

Epitope ID:150927

EU-0100454

Eurodopa

F0347-4695

FT-0603250

GTPL3639

H813

Helfo DOPA

Helfo-Dopa

HMS1568C15

HMS1922J14

HMS2090O08

HMS2093N04

HMS2095C15

HMS2230B04

HMS3261K10

HMS3712C15

HMS501G14

HSDB 3348

HY-N0304

I01-10387

IDI1_000452

Inbrija

Inbrija (levodopa inhalation powder)

Insulamina

IV Levodopa

J10404

KB-28327

KBio1_000452

KBio2_000934

KBio2_003502

KBio2_006070

KBioGR_001177

KBioSS_000934

KM0355

L Dopa

L-.beta.-(3,4-Dihydroxyphenyl)alanine

L-(-)-Dopa

L-(3, 4-Dihydroxyphenyl)-.alpha.-alanine

L-(3, 4-Dihydroxyphenyl)alanine

L-(3,4-Dihydroxyphenyl)-.alpha.-alanine

L-(3,4-Dihydroxyphenyl)alanine

L-(o-Dihydroxyphenyl)alanine

L-3-(3,4-dihydroxy-phenyl)alanine

L-3-(3,4-dihydroxyphenyl)-Alanine

L-3-(3,4-Dihydroxyphenyl)alanine

L-3-(3,4-Dihydroxyphenyl)alanine（L-DOPA ）

L-3-Hydroxytyrosine

L-3,4-Dihydrophenylalanine

L-3,4-Dihydroxyphenylalanine

L-4-5-Dihydroxyphenylalanine

L-b-(3,4-Dihydroxyphenyl)-a-alanine

L-beta-(3,4-Dihydroxyphenyl)-alpha-alanine

L-beta-(3,4-Dihydroxyphenyl)alanine

L-Dihydroxyphenylalanine

L-dopa

L-Dopa, L-3-Hydroxytyrosine

L-DOPA; Levodopa

L-O-Dihydroxyphenylalanine

L-o-Hydroxytyrosine

L-Tyrosine, 3-hydroxy-

L(-)-Dopa

Laradopa

Larodopa

Ledopa

Levedopa

Levodopa (JP15/USP)

Levodopa (JP17/USP/INN)

Levodopa (Sinemet)

Levodopa [USAN:INN:BAN:JAN]

Levodopa [USAN:USP:INN:BAN:JAN]

Levodopa, British Pharmacopoeia (BP) Reference Standard

Levodopa, European Pharmacopoeia (EP) Reference Standard

Levodopa, Pharmaceutical Secondary Standard; Certified Reference Material

Levodopa, United States Pharmacopeia (USP) Reference Standard

Levodopum

Levodopum [INN-Latin]

Levopa

Lopac-D-9628

Lopac0_000454

LP00454

LS-255

Madopa (Salt/Mix)

Maipedopa

MCULE-4743781842

MFCD00002598

MLS000028514

MolPort-000-856-937

N1648

NCGC00015384-01

NCGC00016270-01

NCGC00016270-04

NCGC00016270-06

NCGC00016270-07

NCGC00016270-09

NCGC00016270-10

NCGC00093869-04

NCGC00261139-01

NINDS_000452

NSC 118381

NSC-118381

NSC-759573

NSC118381

NSC759573

Parda

Pardopa

PDSP1_001541

PDSP2_001525

Pharmakon1600-02300205

Prestwick_185

Prestwick0_000017

Prestwick1_000017

Prestwick2_000017

Prestwick3_000017

Prodopa

Prolopa

Q-201294

Ro 4-6316

RTR-020755

s1726

SBB017533

SBI-0050439.P003

SC-10704

SCHEMBL22655

SDCCGMLS-0066924.P001

SMR000058312

Sobiodopa

SPBio_000391

SPBio_001974

Spectrum_000454

Spectrum2_000496

SPECTRUM2300205

Spectrum4_000539

Spectrum5_001899

SR-01000075384

SR-01000075384-1

SR-01000075384-4

SR-01000075384-6

SR-01000075384-7

ST086623

Syndopa

Tox21_110338

Tox21_500454

TR-020755

Tyrosine, 3-hydroxy-

UNII-46627O600J

UNII-QI9C343R60 component WTDRDQBEARUVNC-LURJTMIESA-N

VA11170

Veldopa

Weldopa

WLN: QVYZ1R CQ DQ

WLN: QVYZ1R CQ DQ -L

WTDRDQBEARUVNC-LURJTMIESA-N

Z1762772338

ZINC895199

US Patents and Regulatory Information for levodopa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Roche	LARODOPA	levodopa	TABLET;ORAL	016912-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes

International Patents for levodopa

Country	Patent Number	Estimated Expiration
European Patent Office	1381416
Spain	2256467
Japan	2009019047
Japan	2006508699
Denmark	1318785
European Patent Office	1767196
China	100589796

Supplementary Protection Certificates for levodopa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224