Viewing data from:

DHIVY

NDA

CARBIDOPA; LEVODOPA | N214869 | AVION PHARMACEUTICALS LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

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Today

11033521

Mar. 28, 2039

11439613

Mar. 28, 2039

11819485

Mar. 28, 2039

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

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 | 1 NDC

Highest NADAC/Unit

$3.61

per ea

Lowest NADAC/Unit

$3.61

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
75854070101DHIVY 25-100 MG TABLET	$3.61	EA	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$221.36

Highest Price

$329.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
75854-0701-01DHIVY 25/100MG TAB	$329.74	FSS	Avion Pharmaceuticals, LLC	12/31/2026
75854-0701-01DHIVY 25/100MG TAB	$221.36	Big4	Avion Pharmaceuticals, LLC	12/31/2026

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

Medicare Part D Spending

CMS annual spending data for Dhivy (2024)

Total Spending

$979K

Total Claims

1,703

Beneficiaries

425

Avg Cost/Unit

$3.04

Spending Trend

$504K(2022)→$995K(2023)→$979K(2024)

YoY Change:-4.2%

5yr CAGR:-2.8%

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 -9	View Letter (PDF)
Jul 29, 2022	SUPPL -3	View Letter (PDF)
Jul 1, 2022	SUPPL -2	View Letter (PDF)
Nov 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG;100MG

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 12, 2021

Patents (3) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11033521	Mar 28, 2039	—	—	Yes	—
11439613	Mar 28, 2039	—	—	—	—
11819485	Mar 28, 2039	—	—	—	—