Viewing data from:

LARODOPA

NDA

LEVODOPA | N016912 | HOFFMANN LA ROCHE INC

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Athena Neurosciences, Inc. FDA-1995-P-0005 · 13 docket documents Athena Neurosciences, Inc. filed this citizen petition on April 11, 1995, requesting approval under 21 CFR 314.93 to submit an abbreviated new drug application for carbidopa/levodopa powder for reconstitution to an oral liquid, a dosage form not identical to the reference listed drug Sinemet tablets	Other	2017-03-30	Granted	Athena Neurosciences, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

161 trials from ClinicalTrials.gov, 1 active, 136 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enhancement of Stroke Rehabilitation With Levodopa NCT03735901	Phase 3	Active	University Hospital, Basel, Switzerland	610	2019-06-14 → 2029-06-30
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers NCT01327261	Phase 4	Completed	University of Buenos Aires	24	2009-08 → 2009-12
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa NCT01683253	Phase 4	Completed	Sandoz	150	2012-11 → 2014-12
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)NCT02486432	Phase 1	Completed	NeuroDerm Ltd.	6	2015-04 → 2015-04
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors NCT00906828	Phase 4	Completed	Uppsala University	10	2008-10 → 2009-11
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease NCT00006077	Phase 2	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	50	2000-08 → 2003-07
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact NCT00141518	Phase 4	Completed	AbbVie (prior sponsor, Abbott)	77	2006-03 → 2011-04
Medications for Stopping Cocaine Dependence and Preventing Relapse NCT00218023	Phase 2	Completed	The University of Texas Health Science Center, Houston	101	2006-03 → 2012-04
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients NCT00715520	N/A	Completed	Emory University	33	2007-04 → 2016-09
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 NCT01883505	Phase 2	Completed	NeuroDerm Ltd.	30	2014-01-06 → 2015-04-26

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain12 active DMFs8 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

AJINOMOTO CO INCLEVODOPA

DMF 123791997

DIVIS LABORATORIES LTDLEVODOPA USP

DMF 178742004

SHANDONG XINHUA PHARMACEUTICAL CO LTDLEVODOPA

DMF 225982009

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTDLEVODOPA

DMF 279382014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVODOPA USP

DMF 316122017

AJINOMOTO CO INCLEVODOPA

DMF 316542017

ACELLA PHARMACEUTICALS LLCLEVODOPA

DMF 320572020

MAITHRI DRUGS PRIVATE LTDLEVODOPA USP

DMF 353122020

HETERO DRUGS LTDLEVODOPA

DMF 370472022

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDLEVODOPA

DMF 406082024

MIANYANG SHENGSHI HEALTH TECHNOLOGY CO LTDLEVODOPA

DMF 425012025

MSN LIFE SCIENCES PRIVATE LTDLEVODOPA USP

DMF 434342026

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveLEVODOPA (COMPOUND 7550)

DMF 13671969

KV PHARMACEUTICAL COInactiveLEVODOPA S.R.C. 300MG

DMF 23441974

HOFFMANN LA ROCHE INCInactiveLEVODOPA INJECTABLE

DMF 26641976

DAIICHI SANKYO CHEMICAL PHARMA CO LTDInactiveLEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT

DMF 50441983

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveLEVODOPA

DMF 84441989

EGIS PHARMACEUTICALS PRIVATE LTDInactiveLEVODOPA USP BULK

DMF 125051997

DELMAR CHEMICALS INCInactiveLEVODOPA METHYL ESTER HYDROCHLORIDE

DMF 205222007

TORRENT PHARMACEUTICALS LTDInactiveLEVODOPA

DMF 254982011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (6)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#006 — 500MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982