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Last Updated: September 26, 2022

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

Levodopa has one hundred 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:100
US Patents:10
Tradenames:4
Applicants:4
NDAs:4
Drug Master File Entries: 18
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 123
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
Anatomical Therapeutic Chemical (ATC) Classes 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 CAPSULE;ORAL 016913-002 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 Y 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
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
Shire DOPAR levodopa CAPSULE;ORAL 016913-001 Approved Prior to Jan 1, 1982 DISCN No No 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
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

International Patents for levodopa

Country Patent Number Title Estimated Expiration
European Patent Office 1455755 COMPOSITIONS PARTICULAIRES AMELIOREES DESTINEES A ETRE ADMINISTREES PAR VOIE PULMONAIRE (IMPROVED PARTICULATE COMPOSITIONS FOR PULMONARY DELIVERY) See Plans and Pricing
Spain 2389156 See Plans and Pricing
Portugal 1531798 See Plans and Pricing
South Korea 20150110480 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE) See Plans and Pricing
Hong Kong 1213535 用粉末填充膠囊的劑量分配器 (DOSATOR FOR FILLING A CAPSULE WITH POWDER) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

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