Viewing data from:

ADDERALL XR 10

NDA

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | N021303 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire Development LLC et al v. Rhodes Pharmaceuticals L.P. 1:2017cv01840 2 patentsANDA 210651dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate	D. Del.	2017-12-21	Terminated 2018-04-26	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of SPD465 in Adults With ADHD NCT00202605	Phase 2	Completed	Shire	72	2005-09-29 → 2006-01-06
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
Safety of SPD465 in Treating Adults With ADHD.NCT00152035	Phase 3	Completed	Shire	505	2005-03-10 → 2006-11-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 12 NDCs (6 brand, 6 generic)

Highest NADAC/Unit

$6.81

per ea

Lowest NADAC/Unit

$0.4661

per ea

Brand NDCs

Generic NDCs

Avg Brand: $6.81

Avg Generic: $0.5390

92% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
54092038501ADDERALL XR 15 MG CAPSULE	$6.81	EA	Brand	$0.5546	2026-06-17
54092038101ADDERALL XR 5 MG CAPSULE	$6.81	EA	Brand	$0.4661	2026-06-17
54092038901ADDERALL XR 25 MG CAPSULE	$6.81	EA	Brand	$0.5470	2026-06-17
54092038301ADDERALL XR 10 MG CAPSULE	$6.81	EA	Brand	$0.5315	2026-06-17
54092039101ADDERALL XR 30 MG CAPSULE	$6.81	EA	Brand	$0.5227	2026-06-17
54092038701ADDERALL XR 20 MG CAPSULE	$6.81	EA	Brand	$0.6118	2026-06-17

Showing 6 of 12 NDCs.

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

$224.08

Highest Price

$224.08

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54092-0381-01ADDERALL XR 5MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0383-01ADDERALL XR 10MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0385-01ADDERALL XR 15MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0387-01ADDERALL XR 20MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0389-01ADDERALL XR 25MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0391-01ADDERALL XR 30MG CAP	$224.08	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

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

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2026	SUPPL -40	View Letter (PDF)
Sep 25, 2025	SUPPL -42	View Letter (PDF)
Oct 16, 2023	SUPPL -38	View Letter (PDF)
Feb 28, 2022	SUPPL -36	View Letter (PDF)
Jul 20, 2018	SUPPL -29	View Letter (PDF)
Jan 17, 2017	SUPPL -32	View Letter (PDF)
Apr 21, 2015	SUPPL -31	View Letter (PDF)
Jul 25, 2014	SUPPL -27	View Letter (PDF)
Dec 5, 2013	SUPPL -26	View Letter (PDF)
Jun 18, 2013	SUPPL -24	View Letter (PDF)
Mar 11, 2013	SUPPL -25	View Letter (PDF)
Feb 10, 2012	SUPPL -23	View Letter (PDF)
Nov 18, 2010	SUPPL -20	View Letter (PDF)
Nov 18, 2010	SUPPL -22	View Letter (PDF)
Nov 13, 2008	SUPPL -19	View Letter (PDF)
May 29, 2007	SUPPL -15	View Letter (PDF)
Jul 27, 2006	SUPPL -13	View Letter (PDF)
Jun 20, 2006	SUPPL -10	View Letter (PDF)
Jul 26, 2005	SUPPL -9	View Letter (PDF)
Aug 12, 2004	SUPPL -5	View Letter (PDF)
May 22, 2002	SUPPL -1	View Letter (PDF)
Oct 11, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 2.5MG;2.5MG;2.5MG;2.5MG

RLDAB1

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

No patent or exclusivity listings for this strength.

#006 — 3.75MG;3.75MG;3.75MG;3.75MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002

#002 — 5MG;5MG;5MG;5MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

#004 — 6.25MG;6.25MG;6.25MG;6.25MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002

#003 — 7.5MG;7.5MG;7.5MG;7.5MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

#005 — 1.25MG;1.25MG;1.25MG;1.25MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002