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SINEMET CR

NDA

CARBIDOPA; LEVODOPA | N019856 | ORGANON LLC

2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2022-P-0948 · 3 docket documents Hyman, Phelps & McNamara, P.C. submitted this petition requesting that the FDA determine whether Sinemet CR (carbidopa/levodopa) Tablets in 50 mg/200 mg and 25 mg/100 mg strengths, approved under NDA 019856 and held by Organon, LLC, was withdrawn for reasons of safety or effectiveness, pursuant to s	505(q)	2022-05-27	Withdrawn	Hyman, Phelps & McNamara, P. C.

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

Clinical Trials

93 trials from ClinicalTrials.gov, 1 active, 76 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
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
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
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications NCT01960842	Phase 3	Completed	AbbVie	31	2013-10 → 2015-03
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics NCT02170376	Phase 1	Completed	Bial - Portela C S.A.	80	2011-09 → 2012-01
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers NCT01688089	Phase 1	Completed	Orion Corporation, Orion Pharma	67	2012-09 → 2014-09

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -29	View Letter (PDF)
Jul 23, 2014	SUPPL -28	View Letter (PDF)
Jul 23, 2014	SUPPL -16	View Letter (PDF)
Jul 23, 2014	SUPPL -24	View Letter (PDF)
Feb 7, 2011	SUPPL -27	View Letter (PDF)
Jan 6, 2009	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 30, 1991

No patent or exclusivity listings for this strength.

#002 — 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 24, 1992