Levodopa Patent Expiration

Levodopa is Used for managing off episodes in Parkinson's disease patients treated with carbidopa/levodopa through the inhalation of levodopa powder particles. It was first introduced by Hoffmann La Roche Inc in its drug Larodopa on Approved Prior to Jan 1, 1982. Other drugs containing Levodopa are Dopar, Inbrija, Bendopa. 4 different companies have introduced drugs containing Levodopa.


Levodopa Patents

Given below is the list of patents protecting Levodopa, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Inbrija US12458615 Methods For Providing Rapid Relief Of Motor Fluctuations In A Parkinson'S Disease Patient Oct 21, 2033 Merz
Inbrija US8545878 Capsules containing high doses of levodopa for pulmonary use Nov 16, 2032 Merz
Inbrija US8685442 Capsules containing high doses of levodopa for pulmonary use Nov 16, 2032 Merz
Inbrija US8945612 Capsules containing high doses of levodopa for pulmonary use Nov 16, 2032 Merz
Inbrija US9393210 Capsules containing high doses of levodopa for pulmonary use Nov 16, 2032 Merz
Inbrija USRE43711 Pulmonary delivery for levodopa Feb 03, 2029 Merz
Inbrija US7182961 Particulate compositions for pulmonary delivery Feb 22, 2024

(Expired)

Merz
Inbrija US8404276 Pulmonary delivery for levodopa Mar 19, 2023

(Expired)

Merz
Inbrija US8586093 Pulmonary delivery for levodopa Mar 19, 2023

(Expired)

Merz
Inbrija US9155699 Pulmonary delivery for levodopa Mar 19, 2023

(Expired)

Merz
Inbrija US7384649 Particulate compositions for pulmonary delivery Nov 20, 2022

(Expired)

Merz
Inbrija US6858199 High efficient delivery of a large therapeutic mass aerosol Nov 04, 2021

(Expired)

Merz
Inbrija US7556798 Highly efficient delivery of a large therapeutic mass aerosol Nov 04, 2021

(Expired)

Merz
Inbrija US7146978 Inhalation device and method Apr 16, 2021

(Expired)

Merz
Inbrija US6514482 Pulmonary delivery in treating disorders of the central nervous system Sep 19, 2020

(Expired)

Merz
Inbrija US6613308 Pulmonary delivery in treating disorders of the central nervous system Sep 19, 2020

(Expired)

Merz
Inbrija US6979437 Pulmonary delivery in treating disorders of the central nervous system Sep 19, 2020

(Expired)

Merz
Inbrija US6921528 Highly efficient delivery of a large therapeutic mass aerosol Jun 19, 2020

(Expired)

Merz
Inbrija US8628754 Highly efficient delivery of a large therapeutic mass aerosol Jun 19, 2020

(Expired)

Merz



Levodopa's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Levodopa:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease Kissei Pharmaceutical Co., Ltd. NA COMPLETED
(Sep 1, 2026)
PHASE2
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations Appello Pharmaceuticals, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease Hoffmann-La Roche NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease Yonsei University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study of NE3107 in Early Parkinson's BioVie Inc. NA COMPLETED
(Aug 1, 2026)
PHASE2
A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) H. Lundbeck A/S NA RECRUITING
(Aug 1, 2026)
PHASE1
Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations Universita di Verona NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy Vima Therapeutics NA RECRUITING
(Aug 1, 2026)
PHASE2
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease Intra-Cellular Therapies, Inc. NA COMPLETED
(Jul 1, 2026)
PHASE2
AAV2-GDNF for Advanced Parkinson s Disease National Institute of Neurological Disorders and Stroke (NINDS) NA COMPLETED
(Jun 5, 2026)
PHASE1
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies Georgetown University NA COMPLETED
(Jun 1, 2026)
PHASE2
Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease University Hospital, Toulouse NA COMPLETED
(Apr 1, 2026)
PHASE2, PHASE3
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease UCB Biopharma SRL NA COMPLETED
(Mar 1, 2026)
PHASE2


Levodopa Generic API Manufacturers

Given below is the list of companies who have filed for Levodopa generic, along with the locations of their manufacturing plants worldwide.


Levodopa News

IRLAB Receives Patent Approval, Enhancing Market Exclusivity for Its Drug Candidate...

04 Sep, 2025

Promising drug candidates showing blockbuster potential for Central Nervous System disorders - Drug Target Review

19 Sep, 2024

Hospital doctors warned of potential consequences if they prescribe medications from outside sources

06 Feb, 2024

Puducherry medical professionals discover unique method to deliver medication directly to the brain, securing exclusive rights

01 Feb, 2024

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