Viewing data from:

DYANAVEL XR

NDA

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | N208147 | TRIS PHARMA INC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Expiring < 1yr (5)Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Mar. 29, 2029

Mar. 15, 2027

Mar. 15, 2027

Mar. 15, 2027

Mar. 15, 2027

Mar. 15, 2027

Sep. 7, 2036

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

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 | 1 NDC

Highest NADAC/Unit

$2.77

per ml

Lowest NADAC/Unit

$2.77

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24478010201DYANAVEL XR 2.5 MG/ML SUSP	$2.77	ML	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1001.28

Highest Price

$1001.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24478-0102-01DYANAVEL TM XR SUSP	$1001.28	FSS	Tris Pharma, Inc.	08/31/2028
24478-0102-01DYANAVEL TM XR SUSP	$1001.28	Big4	Tris Pharma, Inc.	08/31/2028

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

Medicare Part D Spending

CMS annual spending data for Dyanavel XR (2024)

Total Spending

$717K

Total Claims

1,567

Beneficiaries

367

Avg Cost/Unit

$13.81

Spending Trend

$44K(2019)→$31K(2020)→$38K(2021)→$84K(2022)→$483K(2023)→$717K(2024)

YoY Change:-1.5%

5yr CAGR:+50.3%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -18	View Letter (PDF)
Oct 16, 2023	SUPPL -16	View Letter (PDF)
Jun 2, 2022	SUPPL -12	View Letter (PDF)
Feb 28, 2022	SUPPL -13	View Letter (PDF)
Feb 8, 2019	SUPPL -5	View Letter (PDF)
Jan 10, 2017	SUPPL -2	View Letter (PDF)
Oct 22, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/ML;EQ 0.5MG BASE/ML

RLD

7 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;ORAL | Approved: Oct 19, 2015

Patents (7) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8062667	Mar 29, 2029	—	—	Yes	—	—
8597684	Mar 15, 2027	—	—	Yes	—	—
8747902	Mar 15, 2027	—	—	Yes	—	—
8883217	Mar 15, 2027	—	—	Yes	—	—
9675703	Mar 15, 2027	—	—	Yes	—	—
10086087	Mar 15, 2027	—	—	Yes	—	—
11590228	Sep 7, 2036	—	—	Yes		—