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LISDEXAMFETAMINE DIMESYLATE

ANDA

LISDEXAMFETAMINE DIMESYLATE | A214547 | NORWICH PHARMACEUTICALS INC

7 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VYVANSE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Takeda Pharmaceutical Company Limited et al v. Norwich Pharmaceuticals, Inc. et al 1:2020cv00953 18 patentsANDA 214547lisdexamfetamine dimesylate	D. Del.	2020-07-16	Terminated 2020-10-30	—

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

API Supply Chain9 active DMFs1 inactive

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

VERANOVA LPLISDEXAMFETAMINE DIMESYLATE

DMF 224422009

CHATTEM CHEMICALS INCLISDEXAMFETAMINE DIMESYLATE

DMF 322892018

SPECGX LLCLISDEXAMFETAMINE DIMESYLATE

DMF 348232020

NORAMCO LLCLISDEXAMFETAMINE DIMESYLATE DRUG SUBSTANCE

DMF 356452021

AUGUST PHARMACEUTICALS LLCLISDEXAMFETAMINE DIMESYLATE INT

DMF 357542021

ALKEM LABORATORIES LTDLISDEXAMFETAMINE DIMESYLATE

DMF 386672023

VERANOVA LPLISDEXAMFETAMINE DIMESYLATE B1625

DMF 388742023

GRANULES INDIA LTDLISDEXAMFETAMINE DIMESYLATE

DMF 417372025

COHANCE LIFESCIENCES LTDLISDEXAMFETAMINE

DMF 422822025

SPECGX LLCInactiveLISDEXAMFETAMINE DIMESYLATE

DMF 322102017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.