Viewing data from:

NEUPRO

NDA

ROTIGOTINE | N021829 | UCB INC

6 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

Today

Sep. 1, 2027

Mar. 1, 2032

Dec. 22, 2030

Dec. 22, 2030

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

7 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
UCB, Inc. et al v. Mylan Technologies Inc. 2:2022cv00216 1 patentrotigotine	D. Vt.	2022-12-12	Terminated 2024-07-01	—
UCB, Inc. et al v. Mylan Technologies, Inc. et al 2:2019cv00148 6 patentsANDA 209982rotigotine	D. Vt.	2019-08-26	Terminated 2020-07-20	—
UCB, Inc. et al v. Mylan Technologies, Inc. 2:2019cv00128	D. Vt.	2019-07-16	Terminated 2021-06-08	—
UCB, Inc. et al v. Actavis Laboratories UT, Inc. 1:2019cv00474 1 patent	D. Del.	2019-03-06	Terminated 2021-04-07	—
UCB, Inc. et al v. Mylan Technologies, Inc. et al 1:2017cv00322	D. Del.	2017-03-24	Terminated 2019-08-26	—
UCB Inc. et al v. Zydus Worldwide DMCC et al 1:2016cv01023 4 patentsANDA 209473Rotigotine	D. Del.	2016-11-03	Terminated 2020-10-07	—
UCB Inc. et al v. Watson Laboratories Inc. (NV) et al 1:2014cv01083 6 patentsANDA 206348Rotigotine	D. Del.	2014-08-21	Terminated 2017-12-13	—

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

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from BioMedEcon, LLC FDA-2017-P-3486 · 8 docket documents BioMedEcon, LLC filed this citizen petition under 21 C.F.R. § 10.30 and section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require manufacturers of dopamine agonists pramipexole, ropinirole, and rotigotine to add black box warnings, revise product labeling and Medication	Other	2017-06-14	Open	BioMedEcon, LLC

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

Clinical Trials

71 trials from ClinicalTrials.gov, 59 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients NCT01631825	Phase 3	Completed	Otsuka Pharmaceutical Co., Ltd.	321	2009-10 → 2012-06
Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain NCT01744496	Phase 4	Completed	UCB BIOSCIENCES GmbH	68	2012-11 → 2014-01
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects NCT00498108	Phase 3	Completed	UCB Pharma	341	2006-01 → 2007-09
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.NCT00881894	Phase 1	Completed	UCB Pharma	52	2008-10 → 2008-12
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease NCT00505687	Phase 3	Completed	UCB Pharma	186	2005-02 → 2008-12
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome NCT00263068	Phase 3	Completed	UCB Pharma	279	2005-12 → 2007-12
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease NCT00594386	Phase 3	Completed	UCB Pharma	258	2002-08 → 2008-12
Effects of Dopaminergic Therapy in Patients With Alzheimer's Disease NCT03250741	Phase 2	Completed	I.R.C.C.S. Fondazione Santa Lucia	94	2016-06 → 2018-11
Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients NCT01523301	Phase 4	Completed	UCB Korea Co., Ltd.	380	2012-04 → 2014-10
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease NCT00599196	Phase 3	Completed	UCB Pharma	381	2002-08 → 2008-12

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

$28.32

per ea

Lowest NADAC/Unit

$28.16

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50474080403NEUPRO 4 MG/24 HR PATCH	$28.32	EA	Brand	—	2026-06-17
50474080303NEUPRO 3 MG/24 HR PATCH	$28.31	EA	Brand	—	2026-06-17
50474080603NEUPRO 8 MG/24 HR PATCH	$28.29	EA	Brand	—	2026-06-17
50474080203NEUPRO 2 MG/24 HR PATCH	$28.26	EA	Brand	—	2026-06-17
50474080103NEUPRO 1 MG/24 HR PATCH	$28.25	EA	Brand	—	2026-06-17
50474080503NEUPRO 6 MG/24 HR PATCH	$28.16	EA	Brand	—	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 (6 FSS, 6 Big4)

Lowest Price

$636.76

Highest Price

$798.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50474-0801-03NEUPRO 1MG 30 PATCH	$798.82	FSS	UCB, Inc.	09/14/2030
50474-0801-03NEUPRO 1MG 30 PATCH	$636.79	Big4	UCB, Inc.	09/14/2030
50474-0802-03NEUPRO 2MG 30 PATCH	$798.82	FSS	UCB, Inc.	09/14/2030
50474-0802-03NEUPRO 2MG 30 PATCH	$636.88	Big4	UCB, Inc.	09/14/2030
50474-0803-03NEUPRO 3MG 30 PATCH	$798.82	FSS	UCB, Inc.	09/14/2030
50474-0803-03NEUPRO 3MG 30 PATCH	$636.92	Big4	UCB, Inc.	09/14/2030

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 Neupro (2024)

Total Spending

$90.1M

Total Claims

77,655

Beneficiaries

14,920

Avg Cost/Unit

$27.60

Spending Trend

$91.6M(2019)→$95.1M(2020)→$94.6M(2021)→$96.5M(2022)→$92.7M(2023)→$90.1M(2024)

YoY Change:-1.3%

5yr CAGR:+3.8%

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

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDROTIGOTINE

DMF 262362012

INTERQUIM SAROTIGOTINE

DMF 264812012

MATRIX PHARMACORP PRIVATE LTDROTIGOTINE USP

DMF 273702013

OLON SPAROTIGOTINE POLYMORPH II

DMF 275542013

TEVA PHARMACEUTICAL INDUSTRIES LTDROTIGOTINE

DMF 294682015

NEULAND LABORATORIES LTDROTIGOTINE USP

DMF 326842018

SOLARA ACTIVE PHARMA SCIENCES LTDROTIGOTINE USP

DMF 378112022

SICHUAN QINGMU PHARMACEUTICAL CO LTDROTIGOTINE

DMF 383632023

OLON SPAInactiveROTIGOTINE

DMF 258632012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jul 14, 2021	SUPPL -22	View Letter (PDF)
Jul 14, 2021	SUPPL -21	View Letter (PDF)
Apr 28, 2020	SUPPL -17	View Letter (PDF)
Apr 6, 2020	SUPPL -19	View Letter (PDF)
Jan 22, 2019	SUPPL -16	View Letter (PDF)
Dec 20, 2018	SUPPL -15	View Letter (PDF)
Feb 27, 2015	SUPPL -7	View Letter (PDF)
Apr 4, 2012	SUPPL -2	View Letter (PDF)
Apr 4, 2012	SUPPL -1	View Letter (PDF)
May 16, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 2MG/24HR

RLD

4 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: May 9, 2007

Patents (4) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8246979	Sep 1, 2027	—	—	Yes		—
9925150	Mar 1, 2032	—	—	Yes	—	—
10130589	Dec 22, 2030	—	—	Yes	—	—
10350174	Dec 22, 2030	—	—	Yes	—	—

#002 — 4MG/24HR

RLD

4 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: May 9, 2007

#003 — 6MG/24HR

RLD

4 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: May 9, 2007

#004 — 1MG/24HR

RLD

4 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Apr 2, 2012

#005 — 3MG/24HR

RLD

4 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Apr 2, 2012

#006 — 8MG/24HR

RLD

4 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Apr 2, 2012