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Last Updated: March 6, 2021

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Levodopa - Generic Drug Details

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What are the generic drug 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 fifty-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:151
US Patents:18
Tradenames:4
Applicants:4
NDAs:4
Drug Master File Entries: 18
Suppliers / Packagers: 1
Bulk Api Vendors: 121
Clinical Trials: 397
Patent Applications: 6,336
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in levodopa?levodopa excipients list
DailyMed Link:levodopa at DailyMed
Recent Clinical Trials for levodopa

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brigham and Women's HospitalEarly Phase 1
Biohaven Pharmaceuticals, Inc.Early Phase 1
Emory UniversityPhase 2

See all levodopa clinical trials

Pharmacology for levodopa
Medical Subject Heading (MeSH) Categories for levodopa

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   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Valeant Pharm Intl BENDOPA levodopa CAPSULE;ORAL 016948-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Shire DOPAR levodopa CAPSULE;ORAL 016913-003 Approved Prior to Jan 1, 1982 DISCN No No   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

Expired US Patents for levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Moodys
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Johnson and Johnson
Colorcon

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