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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
UCB, Inc. et al v. Mylan Technologies Inc. 2:2022cv00216 1 patentrotigotine	VTD	2022-12-12	Terminated 2024-07-01	—
UCB, Inc. et al v. Mylan Technologies, Inc. et al 2:2019cv00148 6 patentsANDA 209982rotigotine	VTD	2019-08-26	Terminated 2020-07-20	—
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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Neupro (2023)

Total Spending

$92.7M

Total Claims

79,382

Beneficiaries

15,325

Avg Cost/Unit

$27.97

Spending Trend

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

YoY Change:+6.4%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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