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EXELON

NDA

RIVASTIGMINE | N022083 | SANDOZ INC

3 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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS PHARMACEUTICALS CORPORATION et al v. DR. REDDYS LABORATORIES, LTD. et al 1:2015cv07964 2 patentsANDA 208318rivastigmine	D.N.J.	2015-11-06	Terminated 2016-03-02	—
Novartis Pharmaceuticals Corporation et al v. Dr. Reddy's Laboratories, Ltd. et al 1:2015cv01026 2 patentsANDA 208318rivastigmine	D. Del.	2015-11-05	Terminated 2016-11-14	—
Novartis Pharmaceuticals Corporation et al v. Watson Laboratories, Inc. et al 1:2011cv08130 3 patentsrivastigmine	S.D.N.Y.	2011-11-10	Terminated 2011-11-28	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
CONFIDENTIAL Citizen Petition from Zydus Noveltech Inc FDA-2017-P-6923 · 4 docket documents Zydus Noveltech Inc. submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act on December 18, 2017, requesting that FDA establish specific criteria for granting in vivo bioequivalence test waivers for generic and 505(b)(2) applications referencing Exelon Patch	505(q)	2017-12-20	Denied	Zydus Noveltech Inc

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

Clinical Trials

71 trials from ClinicalTrials.gov — 1 recruiting, 58 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Toward a Computationally-Informed, Personalized Treatment for Hallucinations NCT04366518	Early Phase 1	Recruiting	Yale University	35	2021-07-15 → 2032-08
Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease NCT00428389	Phase 3	Completed	Novartis	262	2007-01 → 2008-02
Effect of Heat on Rivastigmine TDS Products NCT03915626	Early Phase 1	Completed	University of Maryland, Baltimore	7	2019-10-04 → 2021-05-04
16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients NCT01948791	Phase 4	Completed	Novartis Pharmaceuticals	222	2014-08 → 2015-09
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease NCT00423085	Phase 3	Completed	Novartis Pharmaceuticals	859	2007-01 → 2010-04
Tolerability of Rivastigmine Before and After Switching From Oral Formulation to Transdermal Patch in Alzheimer's Dementia NCT01585272	Phase 4	Completed	Novartis Pharmaceuticals	121	2012-08 → 2015-06
Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment NCT00171795	Phase 3	Completed	Novartis	67	2002-11 → 2005-05
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.NCT02989402	Phase 4	Completed	Novartis Pharmaceuticals	100	2018-12-31 → 2022-12-08
Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease NCT00561392	Phase 4	Completed	Novartis	208	2007-11 → 2008-11
Exelon Patch and Combination With Memantine Comparative Trial NCT01025466	Phase 4	Completed	Inha University Hospital	206	2008-12 → 2010-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 9 NDCs (6 brand, 3 generic)

Highest NADAC/Unit

$22.02

per ea

Lowest NADAC/Unit

$1.73

per ea

Brand NDCs

Generic NDCs

Avg Brand: $21.95

Avg Generic: $1.80

92% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758014231EXELON 4.6 MG/24HR PATCH	$22.02	EA	Brand	$1.81	2026-06-17
00078050115EXELON 4.6 MG/24HR PATCH	$22.02	EA	Brand	$1.81	2026-06-17
00078050315EXELON 13.3 MG/24HR PATCH	$22.01	EA	Brand	$1.85	2025-09-17
66758014431EXELON 13.3 MG/24HR PATCH	$22.01	EA	Brand	$1.85	2025-12-03
00078050215EXELON 9.5 MG/24HR PATCH	$21.82	EA	Brand	$1.73	2026-06-17
66758014331EXELON 9.5 MG/24HR PATCH	$21.82	EA	Brand	$1.73	2026-06-17

Showing 6 of 9 NDCs.

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

$24.68

Highest Price

$512.39

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0503-15EXELON TTS 13.3MG PATCH	$511.47	FSS	Sandoz, Inc.	08/14/2028
00781-7313-31RIVASTIGMINE 13.3MG/24HR PATCH	$28.40	FSS	Sandoz, Inc.	08/14/2028
00078-0501-15EXELON TTS 4.6MG PATCH	$512.39	FSS	Sandoz, Inc.	08/14/2028
00078-0502-15EXELON TTS 9.5MG PATCH	$511.48	FSS	Sandoz, Inc.	08/14/2028
00781-7304-31RIVASTIGMINE 4.6MG/24HR PATCH	$27.11	FSS	Sandoz, Inc.	08/14/2028
00781-7309-31RIVASTIGMINE 9.5MG/24HR PATCH	$24.68	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 for Rivastigmine (2024)

Total Spending

$69.0M

Total Claims

385,825

Beneficiaries

79,469

Avg Cost/Unit

$4.28

Spending Trend

$149.6M(2019)→$121.4M(2020)→$111.4M(2021)→$104.9M(2022)→$91.9M(2023)→$69.0M(2024)

YoY Change:-31.0%

5yr CAGR:-11.8%

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

API Supply Chain16 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDRIVASTIGMINE HYDROGEN TARTRATE

DMF 172492004

DR REDDYS LABORATORIES LTDRIVASTIGMINE HYDROGEN TARTRATE (PROCESS II )

DMF 217812008

INTERQUIM SARIVASTIGMINE

DMF 229742009

AARTI DRUGS LTDRIVASTIGMINE HYDROGEN TARTRATE

DMF 229972009

ACTAVIS GROUP PTC EHFRIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 232652009

JUBILANT BIOSYS LTDRIVASTIGMINE USP

DMF 245022011

ERREGIERRE SPARIVASTIGMINE

DMF 258712011

MATRIX PHARMACORP PRIVATE LTDRIVASTIGMINE USP (PROCESS II)

DMF 264992012

ZYDUS LIFESCIENCES LTDRIVASTIGMINE USP

DMF 275162013

APOTEX PHARMACHEM INCRIVASTIGMINE USP

DMF 290332015

MSN ORGANICS PRIVATE LTDRIVASTIGMINE USP [ROUTE CODE "RP"]

DMF 291332015

ALEMBIC PHARMACEUTICALS LTDRIVASTIGMINE USP

DMF 291992015

APITORIA PHARMA PRIVATE LTDRIVASTIGMINE USP

DMF 295192015

CAMBREX KARLSKOGA ABRIVASTIGMINE

DMF 298262015

MSN ORGANICS PRIVATE LTDRIVASTIGMINE USP

DMF 365292022

SHODHANA LABORATORIES PRIVATE LTDRIVASTIGMINE

DMF 406012024

MYLAN LABORATORIES LTDInactiveRIVASTIGMINE

DMF 244852010

DR REDDYS LABORATORIES LTDInactiveRIVASTIGMINE

DMF 259102012

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 9, 2024	SUPPL -28	View Letter (PDF)
Dec 21, 2018	SUPPL -26	View Letter (PDF)
Nov 3, 2016	SUPPL -23	View Letter (PDF)
Feb 5, 2015	SUPPL -20	View Letter (PDF)
Jul 1, 2013	SUPPL -19	View Letter (PDF)
Sep 5, 2012	SUPPL -16	View Letter (PDF)
Aug 31, 2010	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 4.6MG/24HR

RLDAB

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jul 6, 2007

No patent or exclusivity listings for this strength.

#002 — 9.5MG/24HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jul 6, 2007

#005 — 13.3MG/24HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Aug 31, 2012