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EXELON

NDA

RIVASTIGMINE TARTRATE | N020823 | NOVARTIS PHARMACEUTICALS CORP

4 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Alembic Pharmaceuticals Limited et al 1:2011cv07092 1 patentrivastigmine tartrate	S.D.N.Y.	2011-10-11	Terminated 2012-05-09	—

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 Exelon (2023)

Total Spending

$19.7M

Total Claims

23,311

Beneficiaries

4,339

Avg Cost/Unit

$24.13

Spending Trend

$72.5M(2019)→$58.0M(2020)→$37.7M(2021)→$26.0M(2022)→$19.7M(2023)

YoY Change:-0.1%

5yr CAGR:+1.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs5 inactive

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

CIPLA LTDRIVASTIGMINE TARTRATE USP

DMF 170642003

SUN PHARMACEUTICAL INDUSTRIES LTDRIVASTIGMINE TARTRATE USP

DMF 172892004

ERREGIERRE SPARIVASTIGMINE TARTRATE

DMF 202272007

ORBION PHARMACEUTICALS PRIVATE LTDRIVASTIGMINE TARTRATE

DMF 207532007

ALEMBIC PHARMACEUTICALS LTDRIVASTIGMINE TARTRATE USP

DMF 218002008

APOTEX INCRIVASTIGMINE TARTRATE

DMF 222522008

APITORIA PHARMA PRIVATE LTDRIVASTIGMINE TARTRATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 240862010

MACLEODS PHARMACEUTICALS LTDRIVASTIGMINE TARTRATE

DMF 241532010

JUBILANT PHARMOVA LTDRIVASTIGMINE TARTRATE

DMF 245012011

MSN ORGANICS PRIVATE LTDRIVASTIGMINE TARTRATE USP [ROUTE CODE "RM"]

DMF 280732014

MSN ORGANICS PRIVATE LTDRIVASTIGMINE TARTRATE USP

DMF 357762021

WUXI FORTUNE PHARMACEUTICAL CO LTDRIVASTIGMINE TARTRATE

DMF 408302025

EXCELLA GMBHInactiveRIVASTIGMINE TARTRATE

DMF 214692008

EMCURE PHARMACEUTICALS LTDInactiveRIVASTIGMINE TARTRATE

DMF 222492008

INTERQUIM SAInactiveRIVASTIGMINE TARTRATE

DMF 227732009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveRIVASTIGMINE TARTRATE

DMF 233462009

MYLAN LABORATORIES LTDInactiveRIVASTIGMINE TARTRATE USP

DMF 244422010

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -36	View Letter (PDF)
Nov 3, 2016	SUPPL -35	View Letter (PDF)
Oct 4, 2013	SUPPL -28	View Letter (PDF)
Oct 4, 2013	SUPPL -9	View Letter (PDF)
Oct 4, 2013	SUPPL -27	View Letter (PDF)
Oct 4, 2013	SUPPL -29	View Letter (PDF)
Jul 3, 2006	SUPPL -16	View Letter (PDF)
Sep 24, 2004	SUPPL -14	View Letter (PDF)
May 7, 2004	SUPPL -12	View Letter (PDF)
Apr 21, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#003 — EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 21, 2000

No patent or exclusivity listings for this strength.

#004 — EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 21, 2000

#005 — EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 21, 2000

#006 — EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 21, 2000