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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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 PHARMOVA 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