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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 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-two 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: | 142 |
| US Patents: | 18 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 374 |
| Patent Applications: | 6,927 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | levodopa at DailyMed |
Recent Clinical Trials for levodopa
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centre Hospitalier Universitaire Vaudois | Phase 1 |
| Second Affiliated Hospital of Wenzhou Medical University | Phase 2 |
| University Hospital, Strasbourg, France | Phase 2 |
Pharmacology for levodopa
| Drug Class | Aromatic Amino Acid |
Medical Subject Heading (MeSH) Categories for levodopa
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for levodopa
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2015005768 | Start Trial |
| Russian Federation | 2275900 | Start Trial |
| New Zealand | 523254 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for levodopa
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613296 | 92782 | Luxembourg | Start Trial | 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 |
| 1613296 | CR 2015 00042 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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LOE / Major Patent Expirations 2019 - 2020
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.