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LISDEXAMFETAMINE DIMESYLATE

ANDA

LISDEXAMFETAMINE DIMESYLATE | A202802 | ACTAVIS ELIZABETH LLC

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
SHIRE LLC et al v. ACTAVIS ELIZABETH LLC et al 2:2011cv04053 16 patentsANDA 202802lisdexamfetamine dimesylate	D.N.J.	2011-07-14	Terminated 2011-12-09	—

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

Medicare Part D Spending

CMS annual spending data for Lisdexamfetamine Dimesylate (2023)

Total Spending

$15.1M

Total Claims

70,032

Beneficiaries

31,265

Avg Cost/Unit

$6.58

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

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
Sep 12, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.