Viewing data from:

STALEVO 50

NDA

CARBIDOPA; ENTACAPONE; LEVODOPA | N021485 | ORION PHARMA

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

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

13 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)NCT02764125	Phase 2	Completed	Orion Corporation, Orion Pharma	84	2016-04-08 → 2018-03-27
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease NCT00219284	Phase 4	Completed	Novartis Pharmaceuticals	359	2005-01 → 2008-07
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 NCT01130493	Phase 3	Completed	Impax Laboratories, LLC	110	2010-05 → 2012-01
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa NCT00134966	Phase 3	Completed	Novartis	493	2005-08 → 2007-09
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy NCT00099268	Phase 3	Completed	Novartis Pharmaceuticals	747	2004-09 → 2008-11
Pharmacokinetic Study in Healthy Volunteers NCT02554734	Phase 1	Completed	Orion Corporation, Orion Pharma	15	2015-08 → 2015-11
Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence NCT01468012	Phase 2/3	Completed	New York State Psychiatric Institute	23	2014-07 → 2015-12
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States NCT00143026	Phase 4	Completed	Novartis	184	2005-07 → 2006-06
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off NCT00391898	Phase 4	Completed	Novartis	95	2006-10 → 2008-06
Pharmacokinetic Study With Repeated Doses of Stalevo NCT00693862	Phase 1	Completed	Orion Corporation, Orion Pharma	19	2006-12 → 2008-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$0.7867

per ea

Lowest NADAC/Unit

$0.6200

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00781566901CARBIDOPA-LEVODOPA-ENTACAPONE 50-200-200 MG TAB	$0.7867	EA	Generic	—	2026-06-17
00781565401CARBIDOPA-LEVODOPA-ENTACAPONE 37.5-150-200 MG TAB	$0.7435	EA	Generic	—	2026-06-17
00781561301CARBIDOPA-LEVODOPA-ENTACAPONE 12.5-50-200 MG TAB	$0.6978	EA	Generic	—	2026-06-17
00781562501CARBIDOPA-LEVODOPA-ENTACAPONE 18.75-75-200 MG TAB	$0.6648	EA	Generic	—	2026-06-17
00781564101CARBIDOPA-LEVODOPA-ENTACAPONE 31.25-125-200 MG TAB	$0.6208	EA	Generic	—	2026-06-17
00781563701CARBIDOPA-LEVODOPA-ENTACAPONE 25-100-200 MG TAB	$0.6200	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$4.82

Highest Price

$30.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-5625-0118.75MG/ENTACAPONE 200MG/LEVODOPA 75MG TAB	$4.82	FSS	Sandoz, Inc.	08/14/2028
00781-5637-01CARBIDOPA 25MG/ENTACAPONE 200MG/LEVODOPA 100M	$30.57	FSS	Sandoz, Inc.	08/14/2028
00781-5613-01CARBIDOPA 12.5MG/ENTACAPONE 200MG/LEVODOPA 50	$16.98	FSS	Sandoz, Inc.	08/14/2028
00781-5654-01CARBIDOPA 37.5MG/ENTACAPONE 200MG/LEVODOPA 15	$17.15	FSS	Sandoz, Inc.	08/14/2028
00781-5641-01CARBIDOPA 31.25MG/ENTACAPONE 200MG/LEVODOPA 1	$18.09	FSS	Sandoz, Inc.	08/14/2028
00781-5669-01CARBIDOPA 50MG/ENTACAPONE 200MG/LEVODOPA 200M	$21.75	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data across 4 drug listings matched to this application (2024)

Stalevo 100 (2024)

Total Spending

$130K

Total Claims

Beneficiaries

Avg Cost/Unit

$7.25

YoY Change:-10.7%

5yr CAGR:-1.8%

Stalevo 200 (2024)

Total Spending

$41K

Total Claims

Beneficiaries

Avg Cost/Unit

$6.66

YoY Change:-9.3%

5yr CAGR:-3.9%

Stalevo 150 (2024)

Total Spending

$40K

Total Claims

Beneficiaries

Avg Cost/Unit

$7.58

YoY Change:-5.6%

5yr CAGR:-0.6%

Stalevo 50 (2023)

Total Spending

$40K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$7.89

Spending Trend

$32K(2021)→$34K(2022)→$40K(2023)

YoY Change:-3.5%

5yr CAGR:+0.8%

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 -48	View Letter (PDF)
Dec 31, 2019	SUPPL -42	View Letter (PDF)
Oct 1, 2018	SUPPL -38	View Letter (PDF)
Feb 24, 2016	SUPPL -33	View Letter (PDF)
Jul 24, 2014	SUPPL -28	View Letter (PDF)
Jul 24, 2014	SUPPL -29	View Letter (PDF)
Oct 13, 2010	SUPPL -20	View Letter (PDF)
Mar 5, 2009	SUPPL -12	View Letter (PDF)
Mar 5, 2009	SUPPL -8	View Letter (PDF)
Feb 3, 2009	SUPPL -8	View Letter (PDF)
Feb 3, 2009	SUPPL -12	View Letter (PDF)
Oct 1, 2008	SUPPL -17	View Letter (PDF)
Sep 3, 2008	SUPPL -16	View Letter (PDF)
Aug 7, 2007	SUPPL -11	View Letter (PDF)
Jun 22, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#002 — 25MG;200MG;100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 11, 2003

#006 — 31.25MG;200MG;125MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 29, 2008

#003 — 37.5MG;200MG;150MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 11, 2003

#004 — 50MG;200MG;200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 2, 2007

#001 — 12.5MG;200MG;50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 11, 2003

No patent or exclusivity listings for this strength.

#005 — 18.75MG;200MG;75MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 29, 2008