Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
McKesson
Johnson and Johnson
Mallinckrodt
Baxter

Last Updated: December 7, 2022

Levodopa - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for levodopa
International Patents:101
US Patents:10
Tradenames:4
Applicants:4
NDAs:4
Drug Master File Entries: 18
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 124
Clinical Trials: 435
Patent Applications: 6,919
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
VistaGen Therapeutics, Inc.Phase 2
University of MinnesotaEarly Phase 1
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 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
Shire DOPAR levodopa TABLET;ORAL 016913-004 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roche LARODOPA levodopa CAPSULE;ORAL 016912-006 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 See Plans and Pricing See Plans and Pricing
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 See Plans and Pricing See Plans and Pricing
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for levodopa

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Acorda Therapeutics Ireland Limited Inbrija levodopa EMEA/H/C/004786
Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Authorised no no no 2019-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for levodopa

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 92782 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Moodys
Baxter
Johnson and Johnson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.