Viewing data from:

XELSTRYM

NDA

DEXTROAMPHETAMINE | N215401 | NOVEN PHARMACEUTICALS INC

4 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

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Today

9456993

Oct. 24, 2033

9474722

Oct. 24, 2033

11559501

Jan. 6, 2042

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

29 trials from ClinicalTrials.gov, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety of SPD465 in Treating Adults With ADHD.NCT00152035	Phase 3	Completed	Shire	505	2005-03-10 → 2006-11-07
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD NCT01220440	Phase 4	Completed	Ostfold Hospital Trust	36	2006-01 → 2008-12
Dextroamphetamine as an Adjunct in Cocaine Treatment - 1 NCT00000304	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	120	1997-08 → 2001-08
Safety and Efficacy of SPD465 in Adults With ADHD NCT00202605	Phase 2	Completed	Shire	72	2005-09-29 → 2006-01-06
Monoamine Contributions to Neurocircuitry in Eating Disorders NCT02020408	Phase 4	Completed	University of California, San Diego	88	2011-05 → 2017-12-31
The Reinforcing Mechanisms of Smoking in Adult ADHD NCT00573859	Phase 1/2	Completed	University of California, Irvine	27	2006-09 → 2010-06
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence NCT00630682	Phase 2	Completed	California Pacific Medical Center Research Institute	60	2006-09 → 2011-08
Efficacy and Safety of SPD465 in Adults With ADHD NCT00150579	Phase 3	Completed	Shire	240	2005-01-27 → 2005-06-14
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.NCT00152022	Phase 3	Completed	Shire	412	2005-04-25 → 2005-11-04
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia NCT03772314	Phase 2	Completed	Emory University	44	2019-04-15 → 2023-05-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$16.29

per ea

Lowest NADAC/Unit

$16.24

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68968021503XELSTRYM 13.5 MG/9 HR PATCH	$16.29	EA	Brand	—	2026-06-17
68968021003XELSTRYM 9 MG/9 HR PATCH	$16.27	EA	Brand	—	2026-06-17
68968020503XELSTRYM 4.5 MG/9 HR PATCH	$16.25	EA	Brand	—	2026-06-17
68968022003XELSTRYM 18 MG/9 HR PATCH	$16.24	EA	Brand	—	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$369.93

Highest Price

$461.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68968-0210-03XELSTRYM 9MG/9HR PATCH	$461.72	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0210-03XELSTRYM 9MG/9HR PATCH	$369.93	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0205-03XELSTRYM 4.5MG/9HR PATCH	$461.72	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0205-03XELSTRYM 4.5MG/9HR PATCH	$370.33	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0215-03XELSTRYM 13.5MG/9HR PATCH	$461.72	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0215-03XELSTRYM 13.5MG/9HR PATCH	$370.25	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0220-03XELSTRYM 18MG/9HR PATCH	$461.72	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0220-03XELSTRYM 18MG/9HR PATCH	$371.43	Big4	Noven Therapeutics, LLC	10/14/2026

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

Medicare Part D Spending

CMS annual spending data for Xelstrym (2024)

Total Spending

$200K

Total Claims

417

Beneficiaries

131

Avg Cost/Unit

$15.86

Spending Trend

$51K(2023)→$200K(2024)

YoY Change:-4.2%

5yr CAGR:-4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs1 inactive

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

VERANOVA LPDEXTROAMPHETAMINE SACCHARATE

DMF 150902000

CAMBREX CHARLES CITY INCDEXTROAMPHETAMINE SACCHARATE

DMF 153052001

SPECGX LLCDEXTROAMPHETAMINE SACCHARATE

DMF 154282001

CURIA NEW YORK INCDEXTROAMPHETAMINE SACCHARATE

DMF 160222002

SPECGX LLCDEXTROAMPHETAMINE BASE

DMF 165672003

CURIA NEW YORK INCDEXTROAMPHETAMINE DRUG INTERMEDIATE

DMF 195172006

VERANOVA LPDEXTROAMPHETAMINE SACCHARATE (PROCESS 2)

DMF 240712010

SIEGFRIED USA LLCDEXTROAMPHETAMINE SACCHARATE

DMF 296032016

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE BASE

DMF 326092018

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE SACCHARATE

DMF 380272025

SIEGFRIED USA LLCDEXTROAMPHETAMINE SACCHARATE

DMF 385432023

SPECGX LLCDEXTROAMPHETAMINE SACCHARATE NP

DMF 413472025

SPECGX LLCDEXTROAMPHETAMINE SULFATE USP NP

DMF 413482025

ISP FREETOWN FINE CHEMICALS INCInactiveDEXTROAMPHETAMINE SACCHARATE

DMF 156082001

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 13, 2026	SUPPL -16	View Letter (PDF)
Sep 25, 2025	SUPPL -15	View Letter (PDF)
Dec 2, 2024	SUPPL -11	View Letter (PDF)
Aug 17, 2022	SUPPL -1	View Letter (PDF)
Mar 23, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 4.5MG/9HR

RLD

3 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9456993	Oct 24, 2033	—	—	Yes		—
9474722	Oct 24, 2033	—	—	Yes	—	—
11559501	Jan 6, 2042	—	—	Yes	—	—

#002 — 9MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

#003 — 13.5MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

#004 — 18MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022