Viewing data from:

RYTARY

NDA

CARBIDOPA; LEVODOPA | N203312 | IMPAX LABORATORIES LLC

4 strengths8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

Today

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

Dec. 26, 2028

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

6 cases on OB patents (3 active) from PACER

Case	Court	Filed	Status	Judge
Impax Laboratories, LLC v. ScieGen Pharmaceuticals, Inc. 1:2025cv01233 5 patentsANDA 219953Carbidopa/Levodopa	D. Del.	2025-10-06	Active	—
IMPAX LABORATORIES, LLC v. QILU PHARMACEUTICAL (HAINAN) CO., LTD. et al 2:2025cv03292 5 patentsANDA 220177Carbidopa/Levodopa	D.N.J.	2025-04-25	Active	—
IMPAX LABORATORIES, LLC v. QILU PHARMACEUTICAL CO., LTD. et al 2:2025cv01962 5 patentsANDA 220177Carbidopa/Levodopa	D.N.J.	2025-03-19	Terminated 2025-07-23	—
IMPAX LABORATORIES, LLC v. BIOCON PHARMA LTD et al 2:2025cv01968 5 patentsANDA 220119Carbidopa/Levodopa	D.N.J.	2025-03-19	Active	—
IMPAX LABORATORIES, INC. v. ZYDUS PHARMACEUTICALS USA, INC. et al 2:2017cv13476 1 patentANDA 210911Levodopa/Carbidopa	D.N.J.	2017-12-21	Terminated 2020-05-19	—
IMPAX LABORATORIES, INC. v. ACTAVIS LABORATORIES FL, INC. et al 2:2015cv06934 6 patentsANDA 208522carbidopa and levodopa	D.N.J.	2015-09-17	Terminated 2018-06-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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 | 8 NDCs (4 brand, 4 generic)

Highest NADAC/Unit

$5.00

per ea

Lowest NADAC/Unit

$2.98

per ea

Brand NDCs

Generic NDCs

Avg Brand: $4.24

Avg Generic: $3.29

22% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64896066401RYTARY ER 61.25 MG-245 MG CAP	$5.00	EA	Brand	$3.76	2026-06-17
64896066301RYTARY ER 48.75 MG-195 MG CAP	$3.98	EA	Brand	$3.18	2026-06-17
64896066101RYTARY ER 23.75 MG-95 MG CAP	$3.98	EA	Brand	$2.98	2026-06-17
64896066201RYTARY ER 36.25 MG-145 MG CAP	$3.98	EA	Brand	$3.24	2026-06-17
70710214201CARBIDOPA-LEVO ER 61.25-245 CP	$3.76	EA	Generic	—	2026-06-17
70710214001CARBIDOPA-LEVO ER 36.25-145 CP	$3.24	EA	Generic	—	2026-06-17
70710214101CARBIDOPA-LEVO ER 48.75-195 CP	$3.18	EA	Generic	—	2026-06-17
70710213901CARBIDOPA-LEVO ER 23.75-95 CAP	$2.98	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 | 12 NDCs (8 FSS, 4 Big4)

Lowest Price

$231.45

Highest Price

$393.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64896-0661-01RYTARY 23.75MG/95MG	$313.18	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0661-01RYTARY 23.75MG/95MG	$304.49	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0664-01RYTARY 61.25MG/245MG CAP	$393.53	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0664-01RYTARY 61.25MG/245MG CAP	$386.37	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0662-01RYTARY 36.25MG/145MG CAP	$313.18	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0662-01RYTARY 36.25MG/145MG CAP	$305.86	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027

Showing 6 of 12 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Rytary (2024)

Total Spending

$271.8M

Total Claims

224,759

Beneficiaries

34,890

Avg Cost/Unit

$4.26

Spending Trend

$134.3M(2019)→$164.5M(2020)→$192.4M(2021)→$228.3M(2022)→$266.9M(2023)→$271.8M(2024)

YoY Change:-5.1%

5yr CAGR:+4.9%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -26	View Letter (PDF)
Dec 20, 2019	SUPPL -11	View Letter (PDF)
Oct 31, 2016	SUPPL -6	View Letter (PDF)
Jan 8, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 23.75MG;95MG

RLD

8 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 7, 2015

Patents (8) · 14 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8377474	Dec 26, 2028	—	—	Yes		—
8454998	Dec 26, 2028	—	—	Yes		—
8557283	Dec 26, 2028	—	—	Yes		—
9089607	Dec 26, 2028	—	—	Yes		—
9089608	Dec 26, 2028	—	—	Yes	—	—
9463246	Dec 26, 2028	—	—	Yes		—
9533046	Dec 26, 2028	—	—	Yes		—
9901640	Dec 26, 2028	—	—	Yes		—

#002 — 36.25MG;145MG

RLD

8 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 7, 2015

#003 — 48.75MG;195MG

RLD

8 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 7, 2015

#004 — 61.25MG;245MG

RLD

8 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 7, 2015