Viewing data from:

VYVANSE

NDA

LISDEXAMFETAMINE DIMESYLATE | N208510 | TAKEDA PHARMACEUTICALS USA INC

6 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

39 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate NCT01106430	Phase 3	Completed	Shire	267	2010-06-28 → 2012-07-19
Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers NCT01890785	Phase 1	Completed	Shire	30	2013-07-15 → 2013-08-22
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD NCT02555150	Phase 3	Completed	Rhodes Pharmaceuticals, L.P.	40	2015-09 → 2017-01
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism NCT03337646	Phase 4	Completed	JPM van Stralen Medicine Professional	48	2018-09-26 → 2023-03-31
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder NCT01291173	Phase 2	Completed	Shire	271	2011-05-10 → 2012-01-30
Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity NCT01863459	Phase 4	Completed	Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada	42	2013-04 → 2017-03
Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)NCT00889915	Phase 4	Completed	Duke University	228	2009-04 → 2009-12
Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder NCT02466386	Phase 3	Completed	Shire	113	2015-08-21 → 2020-01-03
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment NCT03926052	Phase 3	Completed	Yale University	61	2019-08-07 → 2024-11-18
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC NCT00746733	Phase 1	Completed	Shire	24	2008-09-08 → 2008-10-26

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$12.37

per ea

Lowest NADAC/Unit

$12.34

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59417012001VYVANSE 60 MG CHEWABLE TABLET	$12.37	EA	Brand	$3.72	2026-06-17
59417011901VYVANSE 50 MG CHEWABLE TABLET	$12.36	EA	Brand	$4.15	2026-06-17
59417011501VYVANSE 10 MG CHEWABLE TABLET	$12.35	EA	Brand	$3.75	2026-06-17
59417011601VYVANSE 20 MG CHEWABLE TABLET	$12.35	EA	Brand	$4.34	2026-06-17
59417011701VYVANSE 30 MG CHEWABLE TABLET	$12.34	EA	Brand	$4.05	2026-06-17
59417011801VYVANSE 40 MG CHEWABLE TABLET	$12.34	EA	Brand	$4.03	2026-06-17

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

$896.25

Highest Price

$897.17

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59417-0119-01VYVANSE 50MG TAB CHEWABLE	$897.17	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
59417-0115-01VYVANSE 10MG TAB CHEWABLE	$897.10	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
59417-0116-01VYVANSE 20MG TAB CHEWABLE	$896.76	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
59417-0117-01VYVANSE 30MG TAB CHEWABLE	$896.28	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
59417-0118-01VYVANSE 40MG TAB CHEWABLE	$896.64	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
59417-0120-01VYVANSE 60MG TAB CHEWABLE	$896.25	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2026	SUPPL -9	View Letter (PDF)
Sep 25, 2025	SUPPL -11	View Letter (PDF)
Oct 16, 2023	SUPPL -7	View Letter (PDF)
Feb 28, 2022	SUPPL -5	View Letter (PDF)
Nov 3, 2021	SUPPL -4	View Letter (PDF)
Aug 2, 2021	SUPPL -3	View Letter (PDF)
Aug 2, 2017	SUPPL -2	View Letter (PDF)
May 23, 2017	SUPPL -1	View Letter (PDF)
Jan 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 10MG

RLDAB

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