Viewing data from:

DYANAVEL XR 5

NDA

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | N210526 | TRIS PHARMA INC

4 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (3)Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Mar. 15, 2027

Mar. 15, 2027

Mar. 15, 2027

Sep. 24, 2038

Feb. 11, 2040

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Tris Pharma, Inc. v. Granules Pharmaceuticals, Inc. 1:2025cv00498 1 patentANDA 220284amphetamine	D. Del.	2025-04-24	Active	—

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 | 4 NDCs

Highest NADAC/Unit

$14.82

per ea

Lowest NADAC/Unit

$7.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24478010801DYANAVEL XR 10 MG TABLET	$14.82	EA	Brand	—	2026-06-17
24478010901DYANAVEL XR 15 MG TABLET	$14.81	EA	Brand	—	2026-06-17
24478011001DYANAVEL XR 20 MG TABLET	$14.80	EA	Brand	—	2026-06-17
24478010601DYANAVEL XR 5 MG TABLET	$7.85	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

$178.49

Highest Price

$391.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24478-0108-01DYANAVEL XR 10MG	$391.68	FSS	Tris Pharma, Inc.	08/31/2028
24478-0108-01DYANAVEL XR 10MG	$336.34	Big4	Tris Pharma, Inc.	08/31/2028
24478-0106-01DYANAVEL XR 5MG	$208.40	FSS	Tris Pharma, Inc.	08/31/2028
24478-0106-01DYANAVEL XR 5MG	$178.49	Big4	Tris Pharma, Inc.	08/31/2028
24478-0109-01DYANAVEL XR 15MG	$391.68	FSS	Tris Pharma, Inc.	08/31/2028
24478-0109-01DYANAVEL XR 15MG	$336.46	Big4	Tris Pharma, Inc.	08/31/2028
24478-0110-01DYANAVEL XR 20MG	$391.68	FSS	Tris Pharma, Inc.	08/31/2028
24478-0110-01DYANAVEL XR 20MG	$336.45	Big4	Tris Pharma, Inc.	08/31/2028

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -10	View Letter (PDF)
Oct 16, 2023	SUPPL -8	View Letter (PDF)
Oct 17, 2022	SUPPL -2	View Letter (PDF)
Jun 2, 2022	SUPPL -1	View Letter (PDF)
Feb 28, 2022	SUPPL -3	View Letter (PDF)
Nov 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 8MG;EQ 2MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 4, 2021

#003 — 12MG;EQ 3MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 4, 2021

#004 — 16MG;EQ 4MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 4, 2021

#001 — 4MG;EQ 1MG BASE

RLD

5 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 4, 2021

Patents (5) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8337890	Mar 15, 2027	—	—	Yes	—	—
8747902	Mar 15, 2027	—	—	Yes	—	—
9675704	Mar 15, 2027	—	—	Yes	—	—
11590081	Sep 24, 2038	—	—	Yes		—
12458592	Feb 11, 2040	—	—	—		—