Viewing data from:

SINEMET

NDA

CARBIDOPA; LEVODOPA | N017555 | ORGANON LLC A SUB OF ORGANON AND CO

3 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

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-1162 · 8 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Carbidopa and Levodopa Tablets in 37.5 mg/150 mg and 25 mg/150 mg strengths suitable for submission as an ANDA, w	Suitability	2025-05-09	Denied	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2020-P-1653 · 3 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Carbidopa and Levodopa Tablets 25 mg/250 mg (ANDA 078536) of Sun Pharmaceutical Industries, Inc. as a new reference standard for conducting in viv	Other	2020-07-13	Withdrawn	Aurobindo Pharma USA, Inc.
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2020-P-0129 · 5 docket documents On January 8, 2020, the law firm Hyman, Phelps & McNamara filed a citizen petition with the FDA requesting that the agency designate ANDA 074260 held by Actavis Elizabeth LLC or another appropriate ANDA as a new reference standard for Carbidopa and Levodopa Tablets in strengths of 25 mg/250 mg, 25 m	505(q)	2020-01-08	Withdrawn	Hyman, Phelps & McNamara, P. C.
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

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.42

per ea

Lowest NADAC/Unit

$1.42

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206019001SINEMET 25-100 MG TABLET	$1.42	EA	Brand	$0.0732	2026-01-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$88.13

Highest Price

$139.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0166-01SINEMET 10-100 TAB	$123.79	FSS	Organon LLC	01/14/2027
78206-0166-01SINEMET 10-100 TAB	$88.13	Big4	Organon LLC	01/14/2027
78206-0190-01SINEMET 25-100 TAB	$139.26	FSS	Organon LLC	01/14/2027
78206-0190-01SINEMET 25-100 TAB	$101.42	Big4	Organon LLC	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Sinemet (2024)

Total Spending

$307K

Total Claims

844

Beneficiaries

222

Avg Cost/Unit

$1.29

Spending Trend

$12K(2021)→$148K(2022)→$279K(2023)→$307K(2024)

YoY Change:-5.7%

5yr CAGR:+6.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -76	View Letter (PDF)
Jul 23, 2014	SUPPL -56	View Letter (PDF)
Jul 23, 2014	SUPPL -68	View Letter (PDF)
Jul 23, 2014	SUPPL -71	View Letter (PDF)
Feb 7, 2011	SUPPL -70	View Letter (PDF)
Jan 6, 2009	SUPPL -69	View Letter (PDF)
Apr 11, 2001	SUPPL -37	View Letter (PDF)
Apr 11, 2001	SUPPL -50	View Letter (PDF)
Apr 11, 2001	SUPPL -55	View Letter (PDF)
Apr 11, 2001	SUPPL -39	View Letter (PDF)
Apr 11, 2001	SUPPL -38	View Letter (PDF)
Apr 11, 2001	SUPPL -40	View Letter (PDF)
Apr 11, 2001	SUPPL -45	View Letter (PDF)
Apr 11, 2001	SUPPL -51	View Letter (PDF)
Apr 11, 2001	SUPPL -36	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG;100MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 25MG;250MG

RLDAB

0 patents0 exclusivities▾

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

#003 — 25MG;100MG

RLDAB

0 patents0 exclusivities▾

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